OMED COMMITTEES

STANDING COMMITTEES

 

Education Committee:
Chairman: Jerome D Waye
650 Park Avenue
New York, NY 10021, USA
Fax: 1-212-2495349
Members: Daldiyono (Indonesia), R Fujita (Japan), Yesus Y Perez (Philippines), A Martin (Italy), L.A. Simon (Hungary), C.B. Williams (UK), N Chopita (Argentina), H Espejo Romeo (Peru), G Machado (Brazil)

Research Committee:
Chairman: Eamonn MM Quigley
University of Nebraska - Medical Ctr
Section of Gastroenterology & Hepatology
600 South 42nd Street
Box 982000
Omaha, NE 68198-2000, USA
Fax: 1-402-559 9004
Members: H.J. Choi (Korea), S Nakazawa (Japan), K Huibregtse (NL), R Lambert (France), J.F. Riemann (Germany), T.H. Wang (ROC), Villa-Gomez (Bolivia), R.A. Kozarek, (USA), A Abrao Neto, (Brazil)

Nominating Committee:
Chairman: T. Sakita (Japan)
Members: G Machado (Brazil), R Llanio (Cuba), H Niwa (Japan), M Crespi (Italy)

Financial Committee:
Chairman: A. Montori (Italy)

"AD HOC" COMMITTEES

Information Committee:
Chairman: Friedrich Hagenmüller
A.K. Altona
Paul-Ehrlich Str. 1
D-22763 Hamburg, GERMANY
Fax: 49-40-88224902
Members: B Krishna Rau (India), Y Oguro (Japan), J St. John (Australia), D Colin- Jones (UK), A Nowak (Poland), W Roesch (Germany), A Celestino (Peru), M Paniagua (Cuba), A Penaloza-Rosas (Colombia)

Terminology and Data Processing Committee:
Chairman: Zdenek Maratka
U5 baterie 40
16200 Praha 6, CZECH REPUBLIC
Fax: 4202-24314574
Members: WSC Chao (Hong Kong), MA Fujino (Japan), S Wilairatana (Thailand), S Brunati (Italy), W Swobodnik (Germany), CW Venables (UK), LAG Juruena Mattos (Brazil), JE Segal (Argentina), M Schapiro (USA)

Minimal Invasive Surgery Committee:
Chairman: Alberto Montori
III Dept. of Surgery
University La Sapienza
00161 Roma, ITALY
Fax: 39-06-44702412
Members: SC Sydney Chung (Hong Kong), Dayasiri Fernando (Sri Lanka), T Yamakawa (Japan), J Perissat (France), A Cuschieri ( UK), G Buess (Germany), AL de Paula (Brazil), P Briceno (Venezuela), J Ruiz (Cuba)

Electronic Communications Committee:
Chairman: J.R. Armengol-Mirò
Secretary: A. Grassi
National Cancer Institute Regina Elena
Viale Regina Elena 291 – 00161 Roma, ITALY
Fax: +39.06.44 57 086 e-mail: mc6512@mclink.it
Members: H.D. Allescher, M. Delvaux, M. Fujino, V. Tejedo Grafia, Cheng-Yi Wang

Ethics Committee (joint with the OMGE Ethics Committee):
Chairman: Jean Escourrou
Service de Gastroenterologie
Hopital de Rangueil
Avenue Jean Poulhes 1
31054 Toulouse Cedex, FRANCE
Fax:33-56132-2176

REPORTS OF STANDING COMMITTEE CHAIRMEN
Education Committee

Education Committee and Research Committee:" Survey on Endoscopic Practice and Priorities throughout the world" Eamonn M.M. Quigley, M.D.

Research Committee

Terminology and Data Processing Committee

Minimally Invasive Surgery Committee

Ethics Committee

Ethics Committee "Medical Ethics in Gastroenterology and Digestive Endoscopy: changing concepts in a changing world" Editor J. Escourrou.

Education Committee
Jerome D. Waye, Chairman (1994-1998)

OUTLINE OF THE ACTIVITIES OF THE OMED
EDUCATION COMMITTEE, MAY 1995

 This Committee has set broad goals for the next four years:
1. A set of teaching video tapes will be made available in each of the major endoscopic specialties. OMED will maintain an up-to-date video library, and copies of tapes will be presented to endoscopy societies, hospitals and chiefs of endoscopy training centers throughout the world.
2. An attempt will be made to establish true "hands on" training programs for beginner endoscopists and for learning advanced techniques. Intensive, short courses have been successfully structured in upper intestinal endoscopy and colonoscopy by Dr. Charles Swan in England. Although these provide only rudimentary entry-level knowledge and are not acceptable in countries where full training programs exist, they will provide the concepts of indications, contraindications and techniques to ensure a safe start in endoscopy.
3. OMED will collect from each national endoscopic society a copy of their constitution, by-laws and guidelines to serve as an international reference source. Information can be shared, and societies that are in the formative stages will no longer need to reinvent the structure of their group anew, nor rewrite guidelines which have already been labored over by other endoscopic societies.
All of these endeavors will need funding to be able to provide the services that are necessary to introduce endoscopy to countries where it is undeveloped and underutilized, to assist in continuing education and to ensure our patients of the safety of the procedure.

ACTIONS BY THE OMED EDUCATION COMMITTEE, MAY 1997

Omed is embarking upon a two-part approach to teaching endoscopy in under developed countries. The overall plan is to present videotape demonstrations of endoscopic procedures to a national meeting at which all people who are interested in gastrointestinal endoscopy and gastroenterology will be invited. The group of people who express an interest in forming endoscopic centers will subsequently (within one year) be invited to attend a practical workshop on endoscopy in that country. Cases will be provided and experts will demonstrate various techniques of basic endoscopic procedures. Lectures and written material will be developed for those basic workshops. The first area contacted for this approach is Africa. Communication has been established with professor Simjee, president of the newly-formed African Federation of Gastroenterology. He has expressed an interest in this program and is currently contacting physicians who may be interested in this approach.

A cadre of teachers in endoscopy is being developed for purposes of teaching endoscopy in underdeveloped countries. If anyone would like to be nominated as a member of the Omed teaching faculty, please contact me with a brief resume detailing your endoscopic experience, the hospitals in which you were trained, a description of the level of expertise, and the types of endoscopy in which you are interested in teaching.

The education committee is attempting to act as a repository for the collection of constitution and by-laws of endoscopic societies throughout the world. This will allow us to know which organizations have established by-laws, and the languages in which they are written. Upon request from any group which is considering formation of an endoscopic society, or which would like further information on patterns which have been developed by other organizations, the names of the endoscopic societies and a specific contact person will be sent so that communications can be established between various endoscopic societies for the exchange of this information. At the present time, the education committee has received twelve responses. The committee has also requested information concerning teaching videotapes and guidelines which have been established for endoscopy. The American Society for Gastrointestinal Endoscopy, seems to have the best-developed set of guidelines. The British Society of Gastroenterology also has several endoscopic guidelines available.

In order to facilitate communication between endoscopic societies and endoscopists worldwide concerning items of interest, Omed is currently on the internet at: www.uni. net/omed. The E-mail address is OMED@uni.net.

Videotapes of the Post-graduate Courses of the last two World Congresses of Gastroenterology, held in Sydney and Los Angeles, are currently available at no cost for national organizations who request them from the Omed General Secretariat. The stipulation is that they will be shown at a National Congress of Gastroenterology within a year after their having been received by the national Society.

They will be also available to individual physicians by request. They are in two formats, Pal and Ntsc. The price for the complete package of 13 videotapes is $ 100 US. This is to defray the cost of videotapes and mailing. The requests should be addressed to Prof. Massimo Crespi, National Cancer Institute "Regina Elena", Viale Regina Elena 291 - 00161 Roma, Italy
Fax: +39.06.4457086 E-mail: as stated above.

OMED EDUCATION COMMITTEE, OCTOBER 1997

The World Organization of Digestive Endoscopy represents organized gastrointestinal endoscopy throughout the world. Many areas of the world are well-served by endoscopic societies, endoscopic organizations, and gastroenterology associations which have active endoscopic components. Each of the many endoscopic organizations throughout the world are autonomous, and most endoscopic organizations or groups of endoscopists develop their own rules, regulations, and organizational structures to suit their particular needs, constituents, and geographic areas. For the most part, rules, regulations, endoscopic guidelines, and organizational structures are developed independently from any other endoscopic organizations. Associations which are well established and have multitudes of members are the groups that characteristically take the lead in the development of practice parameters, practice guidelines, and in the defining of indications, techniques and contraindications for gastrointestinal endocopy. omed has taken upon itself the collation of information from various sources throughout the world and has redefined itself as being the stucture which scan knit the various worldwide organizations into a cohesive array of societies. OMED is the link across all of endoscopy and will disseminate knowledge and education to all of our members, from the highly organized societies to te less-well-developed groups of endoscopists throughout the world.
In an attempt to transmit specific knowledge about endoscopy, OMED has made available the endoscopy videotapes from the last two World Congress of Gastroenterology to any member-constituent GI organization throughout the world. These are available in both PAL and NTSC format, and merely have to be requested by the constituent societies. The intent of OMED is to have these shown at any endoscopic congress held by the individual society, or available to be loaned to any individual or group in that society. Any individual may purchase the entire twelve-videotape packet of World Congress videotapes from the endoscopy courses of the Australia World Congress of Gastroenterology (1990) as well as from the Los Angeles World Congress of Gastroenterology (1994) for US$100 plus mailing. These can be obtained by sending a check directly to: Massimo Crespi, MD - OMED acting president.
The Education Committee has also requested information on constitutions and by-laws from all of the constituent endoscopic organizations. Only a few of the many constituent societies have submitted copies of their constitutions and by-laws, but a list of countries which have sent printed by-laws, will be made available to any organizations who request them.
Some of the larger and more advanced endoscopic societies have multiple guidelines and practice parameters which are "state of the art" position papers. A list will be sent upon request.

The education committee has made initiatives for the "hands-on" teaching of endoscopy in areas in which endoscopy is underdeveloped or under-served. A cadre of teachers is currently available for teaching endoscopy in underdeveloped countries. If any member would like to add their names to the list of available endoscopists who may be requested to travel to foreign countries to begin endoscopic instructions, please contact me with names, addresses, and a curriculum vitae listing hospital affiliations, endoscopic training, current affiliations, and an outline of the endoscopic teaching that you have performed.
All the members of the Education Committee have committed to submitting to the OMED bulletin articles concerning endoscopy in their particular countries. Other endoscopists are encouraged to send in their own experiences in individual countries, unusual endoscopic situations, et cetera. Please send manuscripts directly to: Alberto Montori, MD - OMED News Letter Editor.
OMED is currently on the worldwide web, and can be reached at: "uni.net/omed". This website will be further developed in the future, and is intended to be a bulletin board of worldwide interest in endoscopy. It is hoped that a "chat page" can be formulated to allow interchange between endoscopists throughout the world.
The OMED bulletin will be published twice yearly, and an attempt will be made to disseminate these at all major endoscopic meetings throughout the world; OMED is committed to disseminating knowledge about endoscopy and being the leader in worldwide endoscopy education. Please send in suggestions and comments concerning educational endeavours in the field of gastrointestinal endoscopy.

REPORT OF THE EDUCATION COMMITTEE OMED, APRIL 1998

The Education Committee consists of the following members:
Nestor A. Chopita, MD
Daldiyono, MD
Rikiya Fujita, MD
Glaciomar Machado, MD
Alessandro Martin, MD
Jesus Y. Perez, MD
Herman Espejo Romeo, MD
Laszlo A. Simon, MD
Jerome D. Waye, MD (Chairman)
Christopher B. Williams, MD.
The Education Committee has applied itself over the past four years to several areas with the purpose of bringing information concerning various aspects of endoscopy to endoscopists throughout the world. The major thrust of the Education Committee is not in the training of endoscopists in a formal fellowship program, but rather is focused on bringing information to physicians who already perform endoscopy and educating doctors about endoscopy in countries where there is a need for further endoscopic expertise.
Videotapes from the past two World Congresses of Gastroenterology (Australia, 1990 and USA, 1994) are now available as a package. The price for the entire package is US$100. This is available in either PAL or NTSC format, and is available upon request form Prof. Massimo Crespi, President of OMED. Constituent member societies of OMED may acquire a copy of these videotapes free of charge providing that they agree to show these videotapes at national meetings of their endoscopic societies.
The Education Committee has arranged for a live demonstration endoscopy course to be held in Moscow on April 23-24, 1998. This course will be presented in conjunction with the Olympus Corporation, who will supply equipment and arrange for video transmission.
The Education Committee currently has a list of constitutions and by-laws which is available on request. These constitutions and by-laws had been submitted by member endoscopic societies of OMED three years ago. The Education Committee is currently seeking information from every constituent endoscopic society as to the availability of educational aids for gastrointestinal endoscopy. The aids would include slide series, brochures, written material, and videotapes. A letter has been sent to every president of each constituent endoscopic society throughout the world seeking such information.If any individual members have knowledge of educational material which contain information concerning gastrointestinal endoscopy, please contact Dr. Waye with a listing of this information.
The Education Committee is currently working on developing a brochure for the performance of live courses in endoscopy. Live tele-endoscopic courses are of great benefit in the education of large numbers of physicians in the performance of endoscopic procedures. A section of this brochure will address small, focused endoscopy courses. OMED desires to establish standards for patient safety, patient selection, the performance of such live courses, and patient privacy. The Education Committee is also concerned with the selection of "experts" in endoscopic procedures, and desires to eliminate any risk to the patient from being a subject in a "live" endoscopic course. Most physicians who agree to produce such a course, are, in general, not knowledgeable about the various forms of transmission to a nearby or remote location, and would benefit by having a "primer" on the conduct of these courses. Anybody with a special expertise in the development or production of live courses or is knowledgeable about the video requirements should contact Dr. Waye with such information.
Stimulated by an excellent response from the Research Committee on a previous questionnaire, the Education Committee is collaborating with the Research Committee to distribute a questionnaire worldwide to collect further information on endoscopic practices. The questionnaire is currently in the development phase, and will be distributed during 1998.

MINUTES OF THE MEETING OF THE OMED EDUCATION, MAY 1998

OMED conducted a live endoscopy demonstration in Moscow on April 23-24, 1998. The meeting was sponsored by Olympus and Wilson-Cook. The local organizers were Drs. Poddubny and Fedorov. Approximately 400 Russian physicians attended the two-day workshop, where they saw a wide range of endoscopic procedures including ERCP, stone extraction, endoscopic ultrasound, endoscopic mucosal resection and colonoscopic polypectomy. Several lectures were also given by the faculty members, which consisted of Dr. Massimo Crespi, MD (President, OMED), Dr. Alberto Montori, MD (Treasurer, OMED), Dr. Melvin Schapiro, MD (Vice President, OMED), Dr. Aksel Kruse, MD (Denmark), Dr. Paul Fockens, MD (Amsterdam), Dr. J.R. Armengol Mirò, MD (Barcelona) and Dr. Jerome Waye, MD (New York).
The meeting was a great success and was considered a great benefit to all of the registrants who had traveled from all different parts of Russia to attend the workshop. At the present time various locations are being explored for future workshops.
The committee has developed a list of all the guidelines and brochures concerning endoscopy, as well as the video-educational material available throughout the world. The United States, Japan and Australia have the largest number of published guidelines and instructional videotape material concerning endoscopy. The Education Committee will try to adapt currently published guidelines in English for use by the international fraternity of endoscopy. Permission must be obtained from countries which already have developed guidelines. Once the guidelines have been reformulated for their international applicability, the will be published in the OMED bulletin and on the internet site. We thank the individual societies who responded to our request for information.
OMED had made available a 12-pack packet of videotapes from the Sidney World Congress of Gastroenterology and the Los Angeles World Congresses of Gastroenterology.
These videotapes are available without charge upon request by any of the constituent endoscopic societies, and are available for $100 for anyone else who is interested. If interested, contact Dr. Massimo Crespi and specify whether the video format desired il PAL or NTSC.
The Research Committee, in conjunction with the Education Committee, has distributed a questionnaire about "endoscopic practice and priorities throughout the world".
We urge all of the constituent societies to answer the survey promptly so that information can be gathered on several topics, including the availability of endoscopy in various parts of the world, the types of endoscopy which are considered to be of greatest benefit throughout the world, and the degree of training required for performing endoscopy. The information from this survey will serve to focus the future thrusts of endoscopy for both educational purposes and research needs.
The Education Committee is currently developing a brochure on the requirements for live courses in endoscopy. This will consist of two parts, a technical portion concerning types of transmission, number of cameras, and the adequacy of facilities. The second part will consist of patient selection, patients safeguards, and the role of the nurse/assistant during live demonstration.

OMED has its own web page, which is found at www.uni.net/omed.

The E-mail address is OMED@uni.net.

TEACHING ENDOSCOPY BY INTERACTIVE VIDEOTAPES, MAY 1997
(Melvin Schapiro, MD)

Teaching endoscopy has evolved from artist’s reproduction of endoscopic findings, through the direct capture of high quality still and video images. The limitations of teaching were primarily related to the need for a one on one or very small group experience. The electronic endoscope brought large screen T-V to the teaching environment and a large number of remote transmissions from international centers soon evolved via satellite or telephone lines. The two most important limiting factors to the remote, live transmission technology are the down time during complicated cases, and the costs involved for a one time use.
A radically different approach has been developed by Advance Medical Ventures, a Hollywood based company that utilizes professional motion picture production and editing crews as well as state-of-the-art presentations designed to capture the "live atmosphere".
The format is the presentation of a wide range of pretaped video sequences of procedures actually performed by experts in their individual endoscopy units. In addition to large screen projection, a high quality sound reproduction system and multiple high resolution video monitors are spaced through out the presentation center allowing close-up demonstrations of the technical aspects of complicated therapeutic endoscopic techniques that were performed under real practice situations.
The direct video reproductions are enhanced by split screen technology allowing the audience to focus on many aspects of the procedures with simultaneous visualization of the high resolution endoscopic images. The use of stop-start and rapid rewind methods have been combined with both recorded and live voice-over explanations by the on-site faculty presenters who were filmed in their own units
The audience is further involved in the sessions through the use of interactive "touch-pad" questions and the presence of an expert endoscopic "facilitator" who anticipates questions and the need to review special technical aspects of the presentations. The facilitator is as well scripted with time code associated material so that by watching a special monitor he can amplify certain teaching points agreed with by the faculty in pre-presentation rehearsal sessions.
A special teaching technique is further provided by "telestrator" technology that allows the expert presenter to draw over or provide diagramming to emphasize particular concepts.
This teaching concept was developed over five years ago and has been utilized at the World Congresses of Gastroenterology Post-graduate Endoscopy course in Los Angeles in 1994 and at the American Society for Gastrointestinal Endoscopy’s annual Post -graduate teaching course in San Francisco in 1996. Parts of the program have been reproduced internationally at the UEGW, and at regional society meetings. New endoscopic material is provided every two years so that the latest in technology is provided as well as the opportunity for individuals who have attended previous presentations to return for new material. The attendance evaluations have universally indicated that the program is extremely well received.
The high quality video material has been reproduced on video cassettes for international distribution, and lends itself to the new electronic formats such as DVD and CD-ROM. This enables continued study outside of the presentation environment.
The teaching format has been used by small groups such as a hospital that invites 50 physicians to a meeting, or by large groups with attendance exceeding 2000. Further information concerning presentations and materials are available on the AMV home page: http:/www.amv.com.

" SURVEY ON ENDOSCOPIC PRACTICE AND PRIORITIES THROUGHOUT THE WORLD"
All the member Societies already received the questionnaire.

Those which did not yet reply are invited to do so as soon as possible.

SURVEY ON ENDOSCOPIC PRACTICE AND PRIORITIES THROUGHOUT THE WORLD DEVELOPED BY RESEARCH AND EDUCATION COMMITTEES OF OMED: CHAIRS EAMONN M.M. QUIGLEY, M.D.,JEROME D. WAYE, M.D.
Please Submit Responses to: Eamonn M.M. Quigley, M.D. Gastroenterology and Hepatology University of Nebraska Medical Center Omaha, NE 68198-2000, USA, FAX.+001.402-559-9004, E-MAIL: equigley@mail.unmc.edu

1. Who performs endoscopy in your country? For each type of practitioner, please estimate the percentage of all endoscopy that is performed by these individuals.

A. Upper Gastrointestinal Endoscopy

------- % Family Practitioner
------- % General Internist/General Physician
------- % Gastroenterologist
------- % Surgeon
------- % Other (Please clarify)

B. Colonoscopy

------- % Family Practitioner
------- % General Internist/General Physician
------- % Gastroenterologist
------- % Surgeon
------- % Other (Please clarify)

C. ERCP and Other Interventional Procedures

------- % Family Practitioner
------- % General Internist/General Physician
------- % Gastroenterologist
--------% Surgeon
--------% Other (Please clarify)

2. In your country, please estimate the proportion (as %) of endoscopic examinations that are performed at the following sites:

% hospital inpatient
% hospital outpatient (ambulatory)
% private clinic, attached to a hospital
% free-standing private clinic, not associated with a hospital

Surgical Residency
Gastroenterology Fellowship
Fellowship training in endoscopy other than that provided in
Gastroenterology.

3. Which of the following endoscopic procedures are available in your country? For each, state whether they are

A. Not available
B. Available only at a few center
C. Available only at major referral hospitals or
D. Available widely in community-type hospitals or physician's offices.

A B C D

Esophago- gastroduodenoscopy/upper gastrointestinal endoscopy
Endoscopic therapy of gastrointestinal hemorrhage
Endoscopic therapy of esophageal/gastric varices
Endoscopic placement of gastrostomy/jejunostomy tubes
Colonoscopy
Colonoscopic Polypectomy
ERCP
ERCP with Sphincterotomy
ERCP with Sphincterotomy and placement of stents
Esophageal dilatation and placement of prosthesis
Enteroscopy
Endoscopic Ultrasound
Endoscopic laser therapy of tumors

4. What are the most common indications for the major endoscopic procedures in your country? For each procedure, list the top 3 indications:

A. Upper Gastrointestinal Endoscopy (diagnostic)
B. Upper Gastrointestinal Endoscopy (therapeutic)
C. ERCP
D. Colonoscopy (diagnostic)
E. Colonoscopy (therapeutic)

5. What is the prevailing practice of patient preparation/sedation/anesthesia in your country for:

A. Upper Gastrointestinal Endoscopy

No sedation
Conscious Sedation with Benzodizapine/Opiate/Other (please specify)
General Anesthesia

B. Colonoscopy

No sedation
Conscious Sedation with Benzodizapine/Opiate/Other (please specify)
General Anesthesia

If conscious sedation or anesthesia are employed, who administers these?

The endoscopist
An anesthesiologist
Other (please specify)

6. What are the guidelines for disinfection of endoscopes and accessories in your country?

No generally accepted guidelines - each institution has its own
National guidelines developed by national GI/endoscopic societies
National guidelines mandated by governmental agency

7. In general, would you regard the approach to the disinfection of endoscopes and accessories in your country as...

Adequate
Inadequate

8. What are the major problems in terms of the disinfection of endoscopes in your country?

A. Are there particular or unique infections or infectious agents that cause problems with disinfection in your country" Please specify
B. Do cost concerns limit the performance of disinfection of endoscopes and accessories? If so, please specify.
C. Is there access to adequately trained personnel for the disinfection of endoscopes and accessories?

9. What is the average time taken to clean and disinfect an instrument between uses in your country?

--------------- minutes.

10. What is the disinfectant most commonly used in your country?

11. What do you perceive to be the greatest unmet need in the area of endoscopy in your country? Please list

A. Clinical problems that you feel would benefit from additional endoscopic expertise or technology:
B.    The endoscopic procedures that you would most like to see developed in
your country.

Research Committee
Eamonn M.M. Quigley, Chairman (1994-1996)

OMED RESEARCH COMMITTEE, SAPRIL 1997

Following the resignation of Dr. Stiel, it was my great honor to be nominated to succeed him as Chair of the Research Committee, which became effective in May 1996. I now have the pleasure of updating you on current and planned activities of the Research Committee. Several activities are currently in hand.
A major priority for the Research Committee is the development of an international database on endoscopic priorities. If the Research Committee is to serve as a voice for endoscopic research in the future it is clear that we need data to indicate the important priorities for the development of endoscopy in various parts of the world. Each member of the Research Committee has, therefore, been charged with compiling a list of the most important diagnostic and therapeutic uses of endoscopy in their part of the world. This data will be collated and should be of considerable assistance in the development of research and educational strategies appropriate to different parts of the world. It is my impression that, contrary to popular belief, endoscopy may, in fact, be a very important and almost basic medical tool in many parts of the world, including the developing world, yet priorities may be quite different.
In the past, the Research Committee, Omed and the World Congress have addressed the issue of endoscopic disinfection. I am pleased to announce that the Organizing Committee of the Vienna World Congress have asked me to chair a working party on minimal standards for endoscopic disinfection. While this will be performed within the auspices of a separate working party, the results of this group should be of considerable value to Omed and its Research Committee. Along similar lines, the Omed Research Committee is also working to develop a consensus document on minimal standards for the performance of endoscopy. Our goal here is to establish, through data generated by members of the Research Committee, what are, indeed, the basic requirements for the performance of diagnostic and/or therapeutic endoscopy in various parts of the world. This information should, again, help to provide an appreciation of variations in endoscopic priorities throughout the world, help delineate areas of mutual interest and also assist in developing specific protocols for different parts of the world. Building on this, we also hope to address the standardization of accessory equipment.
A proposal for a multicenter study of Barrett’s esophagus, intestinal metaplasia and adenocarcinoma is under review and proposal in the area of endoscopic hemostasis and laparoscopy will be considered.
The Research Committee will meet in Washington DC, at the time of Digestive Diseases Week – we anticipate lively discussion, and I look forward to updating you of the continuing activities of the Omed Research Committee.

ACTIVITIES OF RESEARCH COMMITTEE OF OMED, APRIL 1998

In association with Dr. Jerome Waye, Chair of the Education Committee of OMED, the Research Committee has been working over the past several months to develop a comprehensive questionnaire on endoscopic priorities throughout the world. This has now been finalized and is about to be distributed to the constituent national societies of OMED. This questionnaire will address several areas, including what endoscopic procedures are performed, who performs them and what has been their training. The purpose is to develop a database on endoscopic practice, training and facilities throughout the world, to provide a basis for further education, training and research initiative in this area. We look forward to the active participation of the constituent national societies in this process and we hope that all of you will complete this questionnaire and, also, that you will communicate with either Dr. Waye or Dr. Quigley regarding any comments or criticisms on the questionnaire. We believe that this is a vital prerequisite to developing short- and long-term strategies for OMED throughout the world.

SUMMARY OF THE SURVEY CONDUCTED BY THE RESEARCH COMMITTEE OF THE S.I.E.D.

During 1997, the Research Committee of the Interamerican Society of Gastrointestinal Endoscopy (SIED), conducted a survey directed to all the Societies of Gastrointestinal Endoscopy within the Latin-American area on "Endoscopic equipment, Accessories, Disinfection and Endoscopy training". As illustrated by the response rate, the survey was well received among constituent societies. A total of 58 endoscopy centers completed the survey: 19 from Brazil, 18 from Argentina, 9 from Colombia, 5 from Uruguay, 4 from Bolivia, 2 from the Dominican Republic and 1 from Peru.
Endoscopic Examinations:
Regarding the frequency of the various endoscopic studies, there was only minor variation between centers: the most frequent studies being esophagogastroduodenoscopy (comprising 65% to 70% of all studies), colonoscopy (20% to 23%) and duodenoscopy (10% to 15%).
Endoscopic Equipment:
Only four of the centers used videoendoscopes exclusively. Most (30) used both videoendoscopes and fiberscopes; a significant number (20), also utilized videocameras, i.e., an adaptor connection to transform a fiberoptic image into a video image. Only 3 centers did no possess video equipment. Fiberscopes are, therefore, still widely used in Latin American countries, even though videoendoscopes are increasing in popularity.
Of those centers that use fiberscopes, 80% use immersible equipment. Of importance in relation to disinfection, 13% of all centers continue to use non-immersible endoscopes and 7% use both immersible and non-immersible. Given the fact that non-immersible equipment has not been manufactured for several years, it can be concluded that a significant number of centers still use this outdated equipment. Of all videoendoscope systems, 60% were housed in endoscopy centers and 40% in public hospitals. This distribuction was similar in all countries with the exception of Argentina where 75% of videoendoscopes were in private and 25% in public centers. This difference in distribution may be explained by the fact that, in Argentina, videoendoscopy is frequently reimbursed at a higher rate than fiberoscopy. In 75% of responses from centers in all other countries, it was stated that both types of endoscopy were reimbursed at a similar rate. It should be noted that 28% of centers responding to the questionnaire did not answer this question; these conclusions are, therefore, drawn from an incomplete sample.
Costs of Endoscopy:
Inquiries regarding fees charged for endoscopic studies provided widely variable responses: charges for diagnostic videoesophagogastro-duodenoscopy ranged from U.S.$ 150 to 600, in various countries. In those countries where there was a difference in fees between video and fiberoscopy (notably Argentina), fiberoscopy was reimbursed at half, or even less, of the rate for videoendoscopy. In general, the fee quoted included the use of the equipment and accessories, as well as, nursing support and other ancillary services. The fee for therapeutic endoscopy varied widely and it was very difficult to draw any conclusions.
Cleaning and Disinfection:
All centers performed manual cleasing of endoscopes and accessories with a neutral detergent or an enzymatic soap and then disinfected with 2% glutataldehyde. Six centers used ethylene oxide for accessories and only 4 used automated "washing machines". Seventy-five percent disinfected equipment after each examination; 25% performed this, only at the end of the day or following cases with known infectious diseases.
With regard to who performs cleaning and disinfection, 41 centers stated that disinfection is performed by trained paramedical personnel; 28 stated that disinfection is carried out by the physician (in several centers both of those options were operative) and only 3 centers use operating room personnel who do not have specific training in endoscopic cleaning and disinfection.
With regard to protection of staff: 100% of responders use gloves, 53,5% protective goggles, 48,3% chin straps, 39,6% disposable aprons and 15,5% boots. Some centers took precautions only in those cases where they knew that the patient was HIV (+).
Accessories:
With regard to access to accessories, 40 centers responded that accessories can be easily obtained in their own countries; 15 experienced some difficulties and 3 did not answer this question. The reasons for such difficulties included the following: high price, absence of hospital budget, lack of stock in the country and a bureaucracy that hinders purchase of accessories. When asked about what accessories are used in the different centers, most (50) use well-known international brands; 12 (from Argentina and Brazil), use national brands (domestically manufactured) and 9 (in Argentina, Bolivia and Brazil) use self-manufactured accessories. Accessory prices vary widely. For example, the price of a papillotomy knife ranged from U.S. $200 to 700 and a polypectomy snare from U.S. $65 to 500. In Argentina and Brazil, domestic brands are, on average, half the price. In Latin America, accessories are, onaverage, twice or three times more expensive than in USA or Europe and this is a major problem for endoscopy centers. All centers stated that they re-use accessories that have previously been disinfected with 2% glutaraldehyde or ethylene oxide.
Endoscopy Training and Certification:
With regard to gastrointestinal endoscopy training, all countries responded that their gastroenterology residencies include training in gastrointestinal endoscopy; both diagnostic and therapeutic. The location of such gastroenterology training is as follows: University Center 51, Private Institution 19, Public Hospital 18. Thirty-five centers responded that specialized, concentrated, endoscopic training experiences were available in their country; in addition to a standard gastroenterology residency. The duration of this additional endoscopy training is variable, but they generally last between one years and two. With regard to the administration of these specialized endoscopic training portions, 27 responses stated that these were administered by Universities, 12 by Scientific Societies, 10 by private and 5 by other hospitals. When asked about wherether a higher qualification in gastroenterology enables a physician to perform endoscopies, all countries answered affirmatively except for Brazil where 14 Centers answered positively an 5 negatively.

With regard to the granting of certification in gastroenterology and endoscopy, 25 answered that such certification is granted by Scientific Societies, 20 by Universities, 16 by Medical Colleges and 9 by a giverment Ministry. In some countries more that one mechanism was operative. In Peru, the Dominican Republic and Uruguay, certification does not require a practival demonstration of endoscopic skills. In other countries requirements appeared to vary. In Brazil 18 Centers stated that a practical demonstration is required; one stated that it is not. In Colombia, 4 answered positively and 5 negatively; in Argentina, 2 answered positively and 16 negatively and in Bolivia, 2 answered positively and 2 negatively.
The last question was whether centers were prepared to receive foreign doctors for endoscopy training. To this, 45 answered affirmatively, 6 negatively and 7 did not answer.
Nevertheless, in all countries that responded to the survey there is at least one center willing to receive foreign trainees.

COMMENTARY BY EAMONN M.M. QUINGLEY, CHAIRMAN RESEARCH COMMITTEE OMED

Dr. Rainoldi and his colleagues are to be congratulated on this important survey. This report illustrates that meaningful surveys are feasible an worthwhile. Several important findings deserve emphasis. These include the persistence of non-immersible endoscopes in a minority of centers and significant variations in policies for cleaning, disinfection ,and staff protection.
Reflecting high costs and difficulties with accessory cleaning, re-use of accessories following disinfection seems universal and should be contrasted with emerging policies regarding single-use in Europe an North America. While the basic components of gastroenterology training appear similar, the details of endoscopic training and certification, in particular, vary considerably both between and within various countries. Surveys such as this provide "real" data on endoscopic practive and should serve as the basis for future projects in endoscopic research, training and education.

WORLD CONGRESS OF GASTOENTEREOLOGY, WORKING PARTY
ON "MINIMAL STANDARD FOR ENDOSCOPIC DISINFECTION", May 1998
Intermediate Report

Present: Eamonn Quigley, MD (USA-Chair), Habib Ben Khelifa, MD (Tunisia), Nestor Chopita, MD (Argentina), Axel Kruse, MD (Denmark), Kazuei Ogoshi, MD (Japan), Rakesh Tandon, MD, PhD (India)
Excused Absence: Walter Bond, MS (USA), Alistair Cowen, MD, FRACP (Australia), Richard Kozarek, MD (USA)
 I)The following interns were distributed:

A. Monograph "Clinical Risks of Infection Associated with Endoscopy" by Dr. Cowen
B. Correspondence to Dr. Quigley from Dr. Bond, draft monograph, "Standard practice for the reprocessing of reusable, heat-stable endoscopic accessory instruments (EAI) used with flexible fiberoptic and video gastrointestinal endoscopes, Correspondence to Dr. Cowen from Dr. Bond regarding his monograph, monograph on "Disinfection, Sterilization and Antisepsis in Health Care", published by the Association for Professionals Infection Control in Epidemiology and draft from CDC on "Creutzfeldt-Jakob disease. Current epidemiology, risk factors and decontamination.
C. Comments on the draft proposal by Dr. Ben Khelifa
D. Comments on the experience in Latin America with endoscopic disinfection from Dr. Chopita

II) Dr. Quigley summarized the format and the order of presentation for the Working Party in Vienna. The presentation for the Working Party is scheduled between 4-6 pm on Monday afternoon September 7, 1998. Following a brief introduction by Dr. Quigley, three-20-minute presentations will follow as follows:

A. Walter W. Bond, MS "Microbiological Considerations in Disinfection and Endoscopy.
B. Alistai Cowen, MD "Clinical Risk of Infection Associated with Endoscop
C. Rakesh Tandon, MD "Endoscopic Disinfection – Practices and Recommendations for Endoscopes and Accessories"

1. This will be followed by a discussion within the panel with particular emphasis on experience in different parts of the world and on controversial issues, in particular, the reuse of accessories.
2. This will be followed by an open discussion and concluding remarks by Dr. Quigley.

III) The remainder of the meeting was taken up with a detailed discussion of Prof. Tandon’s presentation on "Endoscopic Disinfection – Practices and Recommendations for Endoscopes and Accessories". The details of this presentation will be circulated to the members of the committee following receipt of the complete document from Prof. Tandon. The most extensive discussion has surrounded a number of areas which remain controversial.
These are as follows:

A. The issue of reuse of accessories. While it was agreed that some accessories such as sclerotherapy needles should never be reused, there was some divergence of opinion with regard to the reuse of some common accessories such as biopsy forceps and sphinctertomes, The problems here appears to be in relation to the cleaning of these accessories rather than their disinfection.
B. The other contentious issue related to the "soaking time" in disinfectant. This is clearly a major issue which has enormous impact, particularly in the developing world. Again, there was divergence of opinion varying from the 10 minutes recommended by the Gastroenterological Nurses Society of Australia and Gastroenterological Nurses Society of Australia to the 20 minutes recommended in Britain and Europe. Indeed, times of up to two hours had been recommended in some reports.
C. The issued of cleaning, manual vs. machine was discussed in some detail. With regard to manual cleaning, the importance of adequate training of personnel, adequate protection and adequate ventilation were emphasized. Some discussion took place with regard to automated systems, their potential benefits an limitations.
D. There was consensus that non-immersible instruments should not be recommended.
E. While most data relates to 2% glutaraldahyde, there are problems with its use, in particular, with the issue of sensitivity in personnel, which apparently has led to its prohibition in Germany and Denmark. What should the Working Party recommended as an alternative? Should this be paracetic acid or are there other possibilities?
F. Are there some infectious agents that we cannot protect against, in particular, prions and MAI? What should be our statement with regard to these?
G. What should be our position on alternative methods of disinfection such as thermal, superoxide water, etc? Should these be mentioned if there is insufficient data or availability?

IV) Dr. Quigley undertook to distribute the three draft documents to all of the Working Party once these have been received.
There being no further business, the meeting was adjourned.

REPORT OF "AD HOC" COMMITTEES CHAIRMEN

Terminology and Data Processing Committee
Zdnek Maratka, Chairman (1994-1998)

TERMINOLOGY COMMITTEE REPORT, July 1993

The Committee of Terminology in Digestive Endoscopy was founded in 1976 by the European Scociety for Gastrointestinal Endoscopy (ESGE) and was raised to a Committee of the World Society (OMED) in 1978. Its activity has included regular meetings at the European and World Congresses of ESGE and OMED and elaboration of a standard endoscopic terminology suitable for daily practice and computer-aided endoscopic reports. The collaboration within the Committees in the three zones of OMED as well as continuing discussions have resulted in a series of publications, especially the manual of standard endoscopic terminology: Terminology, Definitions and Diagnostic Criteria in Digestive Endoscopy, 1st ed. [Scan J Gastroenterol 1984, 19 (suppl 103): 1–74]. The 2nd revised edition appeared in English (1989), German (1989), Italian (1989), Czech (1989), French (1990); all published by Normed Verlag, Bod Homburg, Germany. The Spanish, Portuguese and Norwegian editions are in preparation as well as the 3rd English edition. This book has been complemented by an atlas of endoscopic pictures presenting the most common findings with a standard description and interpretation (by the same publisher). Five video films have been produced by F. Costentino) documenting standard terminology in upper and lower digestive endoscopy (so far published in English, Italian and German). The publications and video films have been included in the educational programmes of endoscopic and gastroenterological societies.

TWENTY YEAR ANNIVERSARY OF THE OMED
TERMINOLOGY COMMITTEE, April 1998

The evolution of endoscopic terminology and nomenclature has been mentioned in previcus reports (1) but a 20 years anniversary of the committee gives the opportunity to recall the story shortly.

In the seventies the need for a standardized endoscopic terminology became more and more apparent and with the advent of computers was urgent. One of the first innovations which I introduced after being elected President of the European Society for Gastrointestinal Endoscopy (ESGE) in 1976 was founding the Terminology Committee. A round table conference was organized at the IV World Congress of Digestive Endoscopy in Madrid (1978) which aroused unexpected interest and incited inviting representatives of the other zones to participate in future activities. Thus the ESGE Committee was raised to an OMED Committee and since then bore the name Committee for Terminology and Computerization in Digestive Fndoscopy of the World Society of Digestive Endoscopy (OMED).The achievements of this committee during its 20 years existence can be summarized as follows.

First it was necessary to establish basic rules for endoscopic terminology. Three essential requirements were put forward:

1) Endoscopic terminology must be based on visual perception and denomination of macroscopic features as seen through the scope.
2) Accepted terms must be classified and arranged in a system according to the character of the finding; OMED’s classification distinguished nine categories of findings referring to lumen, contents, wall, peristalsis, mucosa, hemorrhage, flat changes, protrusions and depressed/excavated lesions. The list of all terms belonging to the discipline represents a comprehensive database: the OMED nomenclature.
3) The endoscope findings designated by appropriate terms specific for the endoscopic method are interpreted in terms of clinical diagnosis by means of accessory methods like biopsy, if necessary.

Developing a consistent endoscopic terminology was considered to be the primary goal of endeavor. A draft was prepared and repeatedly circulated to the members of the Committee and relevant experts to insure the greatest possible consensus. At all international Congresses symposia and round table conferences were held and the present state of the document was discussed and comments respected.
In 1984 the first publication appeared and gained wide acceptance; it was quickly translated in other languages and updated in further editions (2). At present the forth English edition is ready-to-print. In addition to the book, an atlas (3) and videos (4) were published. A CD-ROM in 5 languages presenting gastroenterology as a discipline viewed by the eyes of the endoscopist and using the OMED nomenclature was published under the name Normedia-Gastro (5). All this work was accomplished thanks to sponsoring by pharmaceutical and endoscopic industry companies as well as by perfect collaboration with Normed Verlag, Bad Homburg.
The OMED nomenclature aims at being a possibly complete list of terms used in digestive endoscopy organized in a hierarchical system and provided by definitions and diagnostic criteria. Being such it should represent a fundamental database. For practical purposes this exhaustive list can be tailored to suit different computer programs, e.g. Minimal Standards for a computerized endoscopic database (6) facilitating a correct formulation of endoscopic records. Customized databases of this kind, however, should use the standardized nomenclature and should not depart from agreed categorization and terminology.

It has been a privilege to chair the OMED Terminology Committee for these 20 years and to see its achievements being accepted by the endoscopic community and further developed by the ESGE Committee for Minimal Standards for Tenninology and Documentation in Digestive Endoscopy.

REFERENCES

  1. ESGE News Letter No.11 (1978) p.7; No.15 (1989) p. 1,5; No. 17 (1983) p. 8; ESGE News- Acta Endoscop. 15 (1987) p. 5; 20 (1988) p. VI; Bulletin OMED III. (1986) p.13; V. (1994) p. 25; OMED News Letter No. 1 (1993) p. 21.
  2. Maratka Z. et al. Terminology, Definitions and Diagnostic Criteria in Digistive Endoscopy, Scandinavian Journal Gastroenterology 19 (1984) Suppl. 103, Normed Verlag, Bad Homburg. English 1984, 1989, 1994; German 1984, 1989; Italian 1986, 1989; Spanish 1986, 1994; Portuguese 1986, 1994; Czech 1989, French 1990; Russian 1996; Norwegian 1996; Brazilian 1995.
  3. Maratka Z. et al. Illustrated Terminology, Definitions and Diagnostic Criteria in Digestive Endoscopy, Normed Verlag, Bad Homburg, English 1992, French 1992, German 1993.
  4. Cosentino F. et al. 5 Videos OMED nomenclature. Normed Verlag, Bad Homburg. English; Italian; German; 1991.
  5. Maratka M., Armengol Mirò J.R. et al. Normedia-Gastro CD-ROM, Normed Verlag, Bad Homburg, 1996.
  6. Crespi M., Delvaux M., Schapiro M. et al. Minimal Standards for a Computerized Endoscopic Database, Am J Gastroenterol 89 (1994) p. 144-153, ESGE Committee for Minimal Standards for Terminology and Documentation in Digestive Endoscopy: Minimal Standard Terminology for Databases in Digestive Endoscopy, Normed Verlag, Bad Homburg, English 1995, Italian 1998.

Minimally Invasive Surgery Committee
Alberto Montori, Chairman (1994-1998)

THE IMPACT OF ENDOSCOPY
ON DIGESTIVE SURGERY

Having been trained as a surgeon in the so-called pre-endoscopic era, I have no doubt that the impact of endoscopy on digestive surgery has been tremendous. In an attempt to identify and analyse the key points of such tremendous impact, I draw my readers’ attention to three different aspects.
The importance of endoscopy in obtaining early diagnosis, its influence on clinical judgement and its role in surgery, by suggesting the most      appropriate surgical approach and technique through a correct diagnosis of the lesion.
 The contribution of digestive endoscopy to a better knowledge of the pathophysiology of several gastrointestinal diseases with enormous consequent benefit in the surgical decision-making process.
The host of therapeutic applications which have become more and more widespread and sophisticated and which have arisen because of the direct visual inspection that endoscopy allows.
Therapeutic endoscopy has perhaps had the most visible impact in terms of reducing morbidity and mortality in the emergency as well as in the high-risk patient. Its application and the consequent refinement of indications for surgery has also produced a reduction in the number of surgical operations performed and has shortened hospitalization periods, thus producing a reduction in the cost of management of surgical patients.
In my opinion, endoscopy has also had an impact on the evolution of digestive surgery. In fact, the same principles of flexible endoscopy have inspired the diffusion of "minimal access surgery" via laparoscopy, which represents a great progress in gastrointestinal surgery.
On the basis of these brief observations, I recommend that gastrointestinal endoscopy be considered a complementary aid to surgery and not a contrasting technique. It has led to a multidisciplinary approach to the gastroenterological patient and to a better co-operation between physicians and surgeons.

FIRST CLINICAL APPLICATIONS IN TELESURGERY
PRESENTED AT 6TH WORLD CONGRESS OF ENDOSCOPIC
SURGERY IN ROME, JUNE 1998

Based on recent scientific and clinical experience of the first applications in telesurgery, the 6th World Congress of Endoscopic Surgery in Rome added two special sessions to include presentations by Professor Guy-Bernard Cadiere, of St. Pierre Hospital in Belgium, and Doctor Anno Diegeler, of the Leipzig Heart Center in Germany. These two surgeons were invited to present their initial results and experience using the Intuitive computer-enhanced surgery system.
Professor Cadiere performed the world’s first computer-enhanced Nissen Fundoplication procedure and Doctor Diegeler and his team performed the world’s first videoscopic coronary artery bypass surgery.
The World Congress of Endoscopic Surgery provides a scientific forum in which to debate and exchange scientific experiences in the field of Minimally Invasive Surgery. While moving toward the next millennium, technologies such as this system will be one of the most significant advancements in endoscopy, helping to redefine minimally invasive surgery as we know it today.
Intuitive is developing a computer-enhanced minimally invasive surgery system that uses proprietary electronics, advanced robotics, and enhanced visualization to greatly improve surgical technique and take surgical precision far beyond what is possible today.
The system is a new surgical technology intended to eliminate the major obstacles to widespread adoption of Minimally Invasive Surgery. It is designed to transform a broad range of open procedures to Minimally Invasive Procedures by making MIS more precise and easier to perform.
Using state-of-the-art computing, sophisticated software and highly-specialized micro-surgical instruments, this system combines the natural hand movements used in traditional open surgery, with the less traumatic approach of Minimally Invasive Surgery – thereby delivering the best of both techniques.
Using this system, surgeons will perform procedures seated at the console while viewing a high-resolution 3-D video image of the surgical field.
The surgeon’s hands rest below the monitor and hold instruments that provide the flexibility of those used in open surgery. Highly-specialized technology simultaneous transfers the surgeon’s exact hand movements made at the console to precise microsurgical movements of the instruments at the operative site.
With this remote control it is nowadays possible to operate with precision and these surgical procedures can be done based on scientific and clinical experience of the application in telesurgery.

ULTRACISION – THE ARMONIC SCALPEL

As we know, electrosurgical units are more often based on monopolar energy sources which transmit the electrical power to the patient by means of a metallic pad placed on the skin. Once the surgeon activates the unit, a flow of electrical energy passes through the patient tissues and, according to the frequency and intensity, cauterisation or cutting is obtained.
Complications from the diffusion of energy to healthy structures or skin burns are frequently reported. Armonic dissection is a totally different approach to obtain sectioning of tissue and simultaneous hemostasis with no risks of inadvertent injury to the surrounding structures.
The Ultracision – Armonic Scalpel is composed by a current generator connected to a piezoelectric transducer which is located inside the handle used by the surgeon. The transducer transforms the electric power into mechanic energy, then transferred to a blade. The blade vibrates linerly for a distance varying between 50 and 100 microns at a frequency of about 55,000 times per second. The blade is incorporated in a mechanism in the shape of scissors. Only tissues incorporated by the surgeons between the two blades undergo the mechanical dissection energy. Low temperature heath is generated, which contributes to vessel coagulation without carbonisation of tissue, a normal effect of most monopolar electrosurgical units.
Therefore, Armonic Dissection and Ultracision guarantee one of the most precise and less invasive dissection methods available today provided by Ethicon Endo-Surgery a Johnson & Johnson Company.

OMED POSTGRADUATE COURSE ORGANIZED
WITHIN THE 6th WORLD CONGRESS OF ENDOSCOPIC SURGERY Rome, JUNE 1998

The Postgraduate Course was organized under the auspices of the OMED, the EAES and the SAGES. The coordinators were J.R. Armengol Mirò, M.D. and M. Crespi, M.D. for OMED, Sir A. Cuschieri, M.D. and J.J. Jakimowicz, M.D. for EAES and J. Ponsky, M.D. and G. Van Stiegman, M.D. for SAGES
This interesting and successful Course was followed by 322 participants for 10 hours a day.
This Postgraduate Course with live interactive demonstrations (16 patients operated in 2 days) with Satellite connection with the Auditoruim of Alitalia where the Nurses’ Seminar took place and with the Hospitals in Milan and Taranto.
The Postgraduate Course was dedicated to "Diagnostic and Interventional Flexible Endoscopy; Interventional Radiology and Endoscopic Surgery: Competing, Complementary, Combined?". The contribution and participation of about 40 specialists in the different minimally invasive methods has brought up the possibility of managing patients through a cooperative efforts. When involved in the management of patients, only the knowledge of the possibilities and limits of each diagnostic and therapeutic approach makes it possible to achieve the best outcome with the lowest morbidity and costs. The Postgraduate Course has been focused mainly on all management options of digestive diseases of surgical interest, including interventional radiology and flexible endoscopy, with updating of all new-coming technologies, from the ultimate imaging technologies to the future role of telerobotics and virtual reality. The technological evolution has been indicated as the path for future wider and wider application of the principles of Minimally Invasive Surgery.

Nonetheless, technology has not been the only commitment of the Course, where special regard has been given to the study and treatment of pre-cancerous lesions, early cancers and other malignancies. Therefore, at the end of the Course, the new profile for the Surgeons of the 3rd millennium has been drawn: an expert in sophisticated technology; good hand skills but also deep cultural roots.

Ethics Committee
Endoscopy and ethics, May 1996

ENDOSCOPY AND ETHICS, MAY 1996

Hippocrate’s Oath has been considered as the physicians’ legal and moral code in the whole world for twenty two centuries.
The Code of Nuremberg defines the conditions in which experiments on human subjects may be authorited. The difterent Ethics Committees, and more recently, Laws about Bio-Ethics attest of the fundamental questions that science and medical technics improvements bring, modifying continuously what gives the worth to life and death to Human being Endoscopy in Gastroenterology, and the permanent development of its diagnostic and therapeutic possibilities, raise new questioning about medical power and medical know how.
Concerning this invasive procedure, Ethics defines collective rules of "logic" and "good practice" that can’t be limited in their dimensions by an individual choice.
These measures allow to establish some rules of conduct we must respect to avoid drifts regarding the patient and the technique.

Even if these basic principles seem obvious and established, to ensure patient’s security ancl cornfolt before, during and after intervention.

ETHICS COMMITTEE REPORT

Among the activities of the Committee, is the publication of the book "Medical Ethics in Gastroenterology and Digestive Endoscopy: changing concepts in a changing world" Editor J. Escourrou, with articles from N Antaki (Syria), Ben Khelifa
- A. Kilani (Tunisie), M.A. Latorzeff - J. Escourrou (France), J. Campos (Colombia), F. Villardell (Spain), M.C. Milano (Argentina), J.H. Solhaug (Norway), B.H. Novis (Israel), C. Francesconi (Brazil) - C. Stanciu (Romania).
The passionate and competent work of Professor Escourrou during his chairmanship of the OMED Ethics Committee has produced a booklet which will be, for several years, a reference text for gastroenterologists and endoscopists. This book is distributed at the World Congress in Vienna and is available through the OMED Secretariat.

In a changing medical world, characterized by an increasing confrontation with administrative rules, budget restrictions, litigations, but also with a decrease of compassion and distorted human relationships, the doctors are confronted too often with difficult and sometimes painful decisions. This publication, which faces these problems from different points of view, will refresh to all of us our duties and obligations and give us the opportunity to stop for a while and ask ourselves: where we are?
We may be proud that Professor Jean Escourrou and his co-authors, under the auspices of OMED, were able to produce such a valuable reference work.

Medical Ethics, Gastroenterology and Digestive Endoscopy : changing concepts in a changing world

Editor Prof. Jean Escourrou, Chairman of the OMED Ethics Committee
An OMED Newsletter Publication
Editor: Prof. Alberto Montori
Co-Editor: Prof. Massimo Crespi
Rome, Italy 1998

The passionate and competent work of Professor Escourrou during his chairmanship of the OMED Ethics Committee has produced the present booklet which will be, for several years, a reference text for gastroenterologists and endoscopists.
In a changing medical world, characterized by an increasing confrontation with administrative rules, budget restrictions, litigations, but also with a decrease of compassion and distorted human relationships, the doctors are confronted too often with difficult and sometimes painful decisions. This publication, which faces these problems from different points of view, will refresh to all of us our duties and obligations and give us the opportunity to stop for a while and ask ourselves: where we are?

I am proud that Professor Jean Escourrou and his co-authors, under the auspices of OMED, were able to produce such a valuable reference work. Thank you Jean, thank you all.

Professor Massimo Crespi President OMED

FOREWORD
Sir Thomas Percival was the first to recognize the necessity of collective thought on the development of new medical procedures back in 1803. The first " Ethical code " concerning research on human beings was developed after the Nuremberg trial, and has since been completed at different meetings.

As Greenberger said, Ethics is a domain of truth or error, where intelligent and sensitive people can sincerely differ. Indeed, countries can have a different conception of Ethics according to the different social values and/or religions in a given society. This concept is constantly questioned due to progress in the fields of biology and medicine. It is not uniform or static, and doesn’t concern medicine alone. Contrary to morals which are based on individual conscience, the notion of ethics is decided on, is arbitrary and must correspond to a collectif consensus ;
In this work, the reader will find the reflections of authors from different countries on existing ethical relationships in numerous fields. Thus, N. Antaki (Allepo, Syria) has analysed particularly well the link between ethics - the goal of which is the common well - being, and morals, which correspond to personal obligations. Habib Ben Khalifa (Tunis) has developed the duties of the gastroenterologist, especially as regards the need to follow the procedure according to the rules, yet respecting the ethical aspect. From this point of view informed consent is the basis of the respect of the patient. The evolution of means of communication and data-processing mean that new problems concerning the respect of the medical secret have arisen. These two aspects have been particularly well analysed by J. Campos (Bogota) and F. Villardell (Barcelona). The limitation of financial means generates a real conflict when it comes to respecting ethics. The same is true for ethics and scientific progress, dealt with by Claudia Milano (Buenos -Aires) and J. Solhaug (Oslo) Numerous practical elements concerning Helicobacter Pylori are illustrated in the chapter by B. Novis (Tel-Aviv). Finally I would like to thank C. Stanciu (Roumania) President of the Ethical Committee of the WGO (World Gastoenterological Organization) together with Carlos Francisconi (Porto Alegre, Brasil) for having dealt with the responsibilities of Ethical Committees when faced with the different problems that transgress this notion. This notion of ethics that requires each thing and every act to be in the right place. This book should enable physicians in general, and gastroenterologists in particular, to exerce their activity whilst respecting restraints and the four basic principles which are the very backbone of Ethics : -the respect of the invidivual, -the respect of knowledge, -the responsability of the researcher and -the refusal of profit.

Jean Escourrou, France

AUTHORS

ANTAKI Nabil MD. President of the endoscopy section of the Syrian Society of Gastroenterology,
PO BOX 6448 Aleppo - SYRIA

BEN KHELIFA Habib MD. Gastroenterology Unit – Hopital Habib Thameur Tunis - TUNISIA

CAMPOS Jaime M.D. Associate Professor, Dean,Faculty of Medicine. National University of Colombia
Bogota - COLOMBIA

ESCOURROU Jean M.D. Professor of Hepatogastroenterology, University Hospital Rangueil
31403 Toulouse - FRANCE

FRANCISCONI Carlos M.D., FACG, Chief, Gastroenterology Division, Hospital de Clínicas de Porto Alegre,
BRAZIL

KILANI A. MD. Gastroenterology Unit – Hopital Habib Thameur, Tunis - TUNISIA

LATORZEFF Marie Ange MD. Hospital LA GRAVE,Toulouse - FRANCE

MILANO Claudia, M.D. Specialist in Gastroenterology.Specialist in Clinical Oncology.
Hospital Nacional Profesor Alejandro Posadas, Buenos Aires - ARGENTINA.

NOVIS B.H. MD. Meir Hospital, Kfar Saba and the Sackler School of Medicine, Tel Aviv University
ISRAEL

SOLHAUG Jan Helge M.D. Dept of Surgery, Diakonhjemmets Sykehus, Oslo - NORWAY

STANCIU Carol, MD. University Hospital " St. Spiridon " Iind Medical Clinic Gastroenterology B-dul Independentei 6600 Iasi - ROMANIA

VILLARDELL Francisco, MD DSc FRCP FACP Postgraduate School of Gastroenterology,
Autonomous University, Hospital Sant Pau Barcelona - SPAIN

CONTENT


ETHICS AND RELIGION
N. Antaki
1
DUTIES OF THE ENDOSCOPIST
Ben Khelifa - A. Kilani
6
DOCTRINE OF INFORMED CONSENT
M.A. Latorzeff - J. Escourrou
18
ETHICS AND MEDIA
Campos
23
ETHICS, ENDOSCOPY AND COMPUTERS
Villardell
29
ETHICS AND MONEY
A view of ethics, money and collective resources.
M.C. Milano
40
ENDOSCOPY AND CLINICAL TRIALS
J.H. Solhaug
47
HELICOBACTER PYLORI DIAGNOSTIC AND THERAPEUTIC
MEASURES : ETHICAL ASPECTS
B.H. Novis
60
BIOETHICS COMMITTEES
C. Francesconi - C. Stanciu
66

ETHICS AND RELIGION

N. ANTAKI

Ethics and Morals have etymologically the same meaning, Ethics stemming from the Greek ethos and morals from the Latin adjective moralis (1). But, in reality, these two words convey two different concepts. For a long time, morals, defining the good and the bad, were used as a reference, as a rule of conduct for science which had to abstain from everything that was morally bad. It can be of religious or philosophical inspiration. Religious morals, taking its roots in faith, doctrine, sacred texts and tradition, can differ according to the different religions; this is why there are several religious morals as opposed to just one. For the catholic religion, for example, moral conscience urges to love, to call upon the good and avoid the bad (2). It prescribes to man the ways and rules of conduct leading to the promised beatitude (3). Morals takes its roots in the faith that man was created as the image of God, and that God made the total gift of himself in Jesus his son; this faith is the basis of catholic moral precepts which respect life and human dignity.
Morals concerns what "should be" as opposed to "what is". It is defined by four essential lines (4-5): inwardness: which calls upon one's own conviction, one's own implication. It is not a simple exterior conformity.
Idealism: Morals is demanding, it suggests an ideal, it leads to a better self. It even demands heroism in certain cases.
Universality: its precepts and authority extend to all men.

Immutability: it is permanent whatever the changes in history. But with the passing of centuries, societies no longer had in common à unanimous religious tradition nor a belief in the universality of moral faith inscribed in the heart of human nature, which replaced it since the age of enlightenment. we cannot assume that we all have the same concept of what is good.

Medical ethics were born because, on the one hand, the world and societies became pluralists and one cannot impose à specific moral to all. We have been lead to tolerate, for moral reasons, what we sometimes ourselves condemn for moral reasons (6); and on the other hand because religious morals have sometimes been unable to face new situations in the biomedical field.
It was attempted to set up the rules of common morals, named ethics, applicable to all, ranging from the texts of the Human Rights to the rules established in Nuremberg and in Helsinki. Then the legislator intervened by voting the bioethic laws.
These ethics are the putting into practice of principles of different origins and place themselves downstream from morals. Instead of being à moral of conviction (religious) it has become a moral of compromise (7). For some, it represents the smallest common denominator acceptable by all. For others, this compromise is meant to bring the different elements of society together on demanding issues (8)

Civil ethics have replaced, in the biomedical field, religious morals. If morals is defined by inwardness, idealism, universality and immutability, bioethics is on the contrary (9): pluralist = aiming to protect diversities.
minimalist = it is realistic. A law which is inapplicable is a bad law
exteriorized - it demands exterior obedience and does not care about personal feelings.
circumstantial = it addresses particular communities at a given time.

Bioethics presents itself as an alternative, although complementary, to indifference or the incapability of morals to establish a dialogue with the sciences of life (10). But it is admitted as evidence that ethical decisions are precarious and in a large measure arbitrary because they are the result of negotiations which can be challenged as new generations of speakers take part in the debate (11).
Religion and ethics meet on many issues. They can nevertheless diverge on important matters such as voluntary interruption of pregnancy, contraception, in vitro fertilization ... In gastroenterology and in digestive endoscopy, ethics and religions have identical positions on many issues.

Ethics and religion in gastroenterology
Many issues in the practice of gastroenterology and digestive endoscopy raise ethical problems such as organ transplants, blood transfusion, medical responsibility, clinical research and experimentation on humans, euthanasia and informed consent. 0n many of these issues, the different religions have a similar approach and a similar attitude. The religious approach considers that issues relating to the respect of the human being, its integrity and life cannot be resolved by simple reference to conscience, be it common or universal, but by reference to Faith, doctrine and sacred texts.
As far as the position of the different religions on gastroenterology ethics is concerned, it varies according to the problems. The different religions are unanimous in allowing clinical research and experimentation on man as long as they do not represent a threat to the life or health of the volunteer, that he has given his free and informed consent and that their aims are therapeutic.

They are unanimous in prohibiting active euthanasia as nobody has the right to take away life even if the person concerned is in a vegetative state of life, because as stipulated in the Jewish Theology, a fraction of infinity stays infinity (12). If there are controversies on passive euthanasia, all religions nevertheless agree not to confuse the maintenance of life and therapeutic relentlessness.
Informed consent and medical responsibility also make unanimity and medical ethics meet the morals of the different religions on these issues. Blood transfusion is acceptable and even desirable for all religions except, for Jehovah’s witnesses (13-16). Even in 1927, well before the perfecting of transfusion techniques, Jehovah’s witnesses explained that according to the Alliance concluded between Jehovah and Humanity, no blood should be consumed in order to respect the sacred character of life. Based on this doctrine they quoted the formal command given by God to Noah: "Everything that moves and has life will be your nourishment. But you will not eat flesh with its soul, that is to say blood. You will be answerable to me for your blood " (GN 9:3 . 5). According to them, this ban was permanent and involved all those wanting to remain faithful to the Alliance. It is for Jehovah’s witnesses a fundamental belief, à conviction with profound implications as it touches their eternal salvation.

During the decades following the declaration of these principles by their religious leaders, the witnesses have remained attached to the belief that one cannot accept blood even in life-threatening situations. They have rejected most of the new techniques refusing not only total blood but also red cells concentrates, plasma, white blood cells and platelets.

However there are a few methods on which their position is not as clear. It is the case of albumin, immunoglobulins, and preparation for hemophiliacs. Laws and jurisprudence are currently clear enough to allow Jehovah’s witnesses to refuse transfusions and to clear hospitals and doctors of their responsibility. The position is clear and without ambiguity: the patient’s will must be respected on condition that it is freely expressed. The discovery of the hepatic virus .B, C and G and the ravages of Aids have given more arguments to those who reprove transfusion against somebody's will, transfusion not being as safe as doctors once thought. Refusal of transfusion can go against the personal morals of the doctor, telling him to do everything to preserve the life and health of his patient, but bioethics bases itself on the immutable principle of respecting the wish of the person who has the right to refuse a treatment even at the cost of his life.

Let us now talk about organ transplants. Religious morals and medical ethics admit that transplants should be a gift, clear, free and anonymous. In addition, most religions have in common (17):
- The respect of the wishes of the deceased.
- The certainty of the irreversible character of death.
- The respect of the appearance of the corpse.
Unanimously a preliminary consent is requested from the donor (free consent and revocable at any time), that the gift is free, based on the principle of the non patrimoniality of the human-body (free, anonymous and non- patentability of the body and its parts) (18). In addition, they proclaim that transplants should only be carried out with the therapeutic aim to save a human life and not to experiment.
On all these points, the Catholic, 0rthodox, Protestant, Muslim, Buddhist and part of Judaism religions agree. 0n the other hand, Hinduism and Shintoism are against transplants, this is why there are virtually no hepatic transplants in Japan except from partial transplants from live donors (19-23). The problem lies with the criteria of the definition of death. For the above mentioned religions and for ethics, the death criteria is cerebral death, which allows the taking of viable organs. 0n the other hand, for Islam, the death criteria is not the cerebral death, but the definitive stopping of the heart (24), therefore making it impracticable to transplant from dead donors. But a progressive tendency (rejected by the strict Islam) accepts, since the Amman Conference of 1986, cerebral death as an alternative to the definitive stopping of theheart in the definition of death.
For strict Judaism, death is defined as the simultaneous abolition, total and irreversible, of the respiratory, cardiac and neurologic functions, making transplants impossible. But the favorable tendency towards transplants has increased thanks to two ideas (25):

- The kidney taken and transplanted is alive again due to the transplant and therefore outside the laws on the respect of the body.
- The transplant aims at saving the life of the receiver and it prevails on all the interdictions of the Torah.

Remains the problem of the consent. If the informed, clear and revocable consent is an essential condition for all religions, two divergent points emerge:

- For Islam, even if a donor has given his consent while still alive, it is the right of his heirs to dispose of his body after his death. They can annul the consent given and refuse the organ donation expressed by the deceased (26). On the other hand, to increase the number of organs to be transplanted, some laws no longer request a clear or active consent and accept a presumed consent, i.e. the non-refusal of transplant by the donor while still alive.
As far as organ transplants from a live donor are concerned (partial liver), religions and ethics accept this as long as there are no other alternatives and if there is no negative impact on the life or health of the donor and if the consent is given freely (quid psychological pressure on a parent donor to his child?).
Finally we are heading for the concept of the death of the Brainstem as opposed to cerebral death.

REFERENCES:

  1. GOLD F,, Ethique, éthique medical, bioéthique. Repères et situation
    éthiques en médecine. Ellipses, 1996. 10-18.
  2. GAUDIUM et SPES, Ch, 16, Concile Vatican II
  3. CATECHISME DE L'EGLISE CATHOLIQUE, Mame/Pl on, 1992;405
  4. CATECHISME DE L'EGLISE CATHOLIQUE, Mame/Plon, 1992;406-407
  5. DURANT G La bioéthique, méthodes et fondement, Les cahiers scientifiques,
    Montréal, ACFAS, 1989; p.87-96
  6. FAGOT.LARGEAULT A., La réflexion philosophique en bioéthique. Les fondements de la bioéthique, De Boeck, Université, 1992, p, 11-26
  7. GOLD F., Ethique, éthique médicale, bioéthique. Repères et situations
    éthiques en médecine. Ellipses, 1996,p,10-18
  8. GOLD F., Idem
  9. DURANT G Ethique, droit et régulation alternative. Les fondements de la
    bioéthique, De Boech Université, 1992, p.63-75
  10. DOUCET H., la contribution du théologien en bioéthique. Les fondements de la
    bioéthique. De Boech Université, 1992, p.49-62
  11. FAGOT.LARGEAULT A., La réflexion philosophique en bioéthique, Les cahiers
    scientifiques, Montréal, ACFAS, 1989, p. 3-16
  12. GUEDJ P; La recherche médicale dans le Judaïsme, la lettre de RAMBAM, Medica Judaica 23:11
  13. DEVINE R., Save the Body-Lose the Soul; Health Progress, June 1989
  14. THOMAS J.M. Meeting the surgical and ethical challenge presented by Jehovah's
    Witnesses, Canadian medical association journal, vol 128 1153-1154, 1983
  15. GARAY A., GONI P., La valeur juridique de l'attestation de refus de
    transfusion sanguine. Les petites Affiches, N 97, p.14-18, 1993
  16. JAMA, vol. 246,2471-2472, 1981
  17. JACOB I., prélèvements d'organes, Revivre, N° 54, 1992
  18. Loi N 94-654 du 29 Juillet 1994, le dictionnaire permanent Bioéthique e
    Biotechnologies, Editions législatives.
  19. KREIS H., Ethique et transplantation, Administration numéro spécial,
    p;37-49, 1997
  20. VERSPIEREN P. Transplantation et catholicisme, Administration numéro spécial p.51-53, 1997
  21. BOUBAKEUR D., l'Islam et la transplantation, Administration numéro spécial,
    p.57-60, 1997
  22. BOTBOL E., Ethique Juive et transplantation d'organes, Administration numéro
    spécial, p.61-64, 1997
  23. ABEL 0., l'éthique protestante, Administration numéro spécial p.65-66, 1997
  24. .ALBOUTI S.R., kadaya fikhiye mouassira, edition Farabi-Damas p.128-131,1994
  25. NAJMAN A., Greffes d'organes, une éthique de la décision, la lettre de RAMBAM, Médica Judaica N° 20, p.11-13
  26. ALBOUTI S.R., kadaya fikhiye mouassira, edition Farabi.Damas p.132, 1994
  27. THOUVENIN D., Les règles juridiques organisant l'activité de transplantation
  28. d'organes, Administration p.29-36, 1997

DUTIES OF THE ENDOSCOPIST
H. BEN KHELIFA, A. KILANI

INTRODUCTION 
PRIMUM NON NOCERE
Gastro intestinal endoscopy (G.I) is neither infallible nor absolutely safe, and thus becomes a subject of medical ethics which rely on 2 principles (1) :
1/Autonomy of the endoscopist,
2/Beneficence, nonmaleficence and justice for the patient.
The endoscopist must always consider the patient’s best interest and keep in mind that diagnostic and therapeutic safety are foremost, and that endoscopy is not solely guiding the endoscope. So, the duties of the endoscopist play in 3 ways :

  1. He must be competent
  2. The endoscopy unit must be properly organized
  3. The examination must be assessed with standards of care and
    quality assurance.

COMPETENCE OF THE ENDOSCOPIST
Competence in endoscopy assumes a combination of technical and cognitive skills, and requires correct interpretation of abnormal findings. In most countries the proper background is considered to be a formal postgraduate training in gastroenterology.

a)Training :The trainee must learn when endoscopy is indicated
(2 , 3 ) , how to reduce the possible danger of a false diagnosis, and of an iatrogenic lesion,  and how to use endoscopically derived informations in clinical practice ( 4 ). An ethical problem arises in teaching endoscopy (8). The welfare of the patient must always be ensured , so that he is never endangered or exposed to excessive discomfort by the teaching process.
b) Maintaining competency in endoscopic skills is mandatory ,and so, the learning process does not stop at the end of the training period, but should be an ongoing educational process (6-7-8). It is imperative that the endoscopist documents his continuing education effort in the rapidly developing field of GI endoscopy. Self training must occur on a background of basic endoscopic skills , and each endoscopist must assess when additional formal training is necessary before undertaking a new kind of endoscopic procedure (6).

THE ENDOSCOPY UNIT
The endoscopy unit should be properly designed and establish guidelines to render the examination efficient and safe (1O) with :

  1. Room, allowing ideally the endoscopic examination of upper gastrointestinal tract separated from the examination of the distal gastrointestinal tract ( 11 ).
  2. Furnishings and fittings : Examination table, storage space for accessories, sufficient endoscopes, electrocautery devices etc...
  3. Cleaning and disinfection area with good standards.
  4. Radiography room, when procedures utilizing radiological equipment are
    performed.
  5. Preparation and recovery room with cardiopulmonary resuscitation
    equipment for emergency cases.
  6. Photodocumentation of pertinent findings.
  7. If endoscopic procedures are performed in the outpatient or office setting, standards similar to those of the hospital endoscopy unit must be maintained. The one described above is an ideal setting and there is today the need to improve the existing services at least to that standard.

PREPROCEDURAL ASSESSMENT

  1. CONSULTATION : is a very important step during which the endoscopist should :
    document information related to the patient’s history, physical
    examination, relevant X-ray and laboratory data.
    evaluate clearly indication of endoscopy : this point is very
    important.
    inquire about the current medications, and drugs allergy of the patient,
    determine risk of the procedure to optimally manage problems related to pre-existing medical condition, and to allow appropriate post procedural care in the event of any adverse reaction.
    This kind of approach has to be tailored to the level of education of the patient and to the standards of medical practice within the individual country. 
  2. INFORMED CONSENT 
    The performance of endoscopy must take into account both the patient’s autonomy and the question of fairness in the patient-doctor relationship (12 ). With respect to autonomy, the patient has always the right to refuse endoscopy . But gastroenterologists have not only an ethical and moral duty to obtain informed consent prior to procedures, but a legal one as well. It is an absolute precondition of therapeutic endoscopy, or endoscopy for research purposes ( 13, 14 ). The endoscopist should be certain to explain the procedure to the patient, including what will occur before, during, and after it is completed. The nature of the procedure should be described, the benefits outlined, the risks and complications must be detailed . All reasonable alternatives to the proposed procedure should be presented. The informed consent gives a good opportunity to communicate with the patient and to develop mutual respect. The endoscopist must be mindful of the fact that informed consent is a process of disclosure and deliberations, not merely the signing of a form.
    Exceptions to informed consent are (13) emergency, incompetence, therapeutic privilege, waiver and legal mandate .
    Consents in offices are as important as those obtained in hospitals. It is best to have consent witnessed.
  3. WRITTEN INFORMATION AND PSYCHOLOGICAL ASPECTS OF G.I
    ENDOSCOPY.
    The use of written information ( 16 ) is a useful supplement to personal instructions and advice given by the doctor or nurse prior to the procedure but is not a substitute for the physician-patient interaction. Patient input is pivotal in designing patient - directed information material.
    Psychological techniques ( 15 ) can also be used to assist patients in coping with the stress of endoscopy by providing a variety of strategies , including the provision of information, relaxation, cognitive-behaviour approaches and modelling. Being treated as a whole person and not just a subject for investigation makes a major contribution to satisfactory procedure.
  1. EXAMINATION STANDARDS OF CARE
    These define the responsibilities that a physician gastroenterologist who performs endoscopy must fulfil in the care of any patient. The level of care required is that which a reasonable and prudent physician should deliver in the management of any patient, including the following :

a) Endoscopic competence of the endoscopist and his staff and appropriate endoscopy suite. These problems were discussed above.
b) Infection control,
c) Sedation and monitoring ,
d) Personal and expanded duty ,
e) Endoscopic complications, claims and risk management ,
f) Quality assurance.

  1. INFECTION CONTROL :
    Infection during the endoscopic procedure is possible in certain situations for the patient or the personnel at risk, and requires that standards of prevention be followed. Infection can be transmitted by means of inadequately cleaned endoscopes, contaminated water bottles and irrigating solutions, improper use of inadequately designed automatic endoscope washing machines, use of substandard disinfectant solutions, and inadequate drying of the endoscope channels prior to overnight storage ( 17,18 ,19).

The endoscopic devices must be considered semi-critical material and should therefore be sterilized or at least receive high level disinfection. Liquid chemical agents are used almost exclusively for disinfection. Several alternative preparations are recommended  : Of these glutaraldehyde at 2 % concentration is the disinfectant most used and recommended as a first choice in various International guidelines (2O). The disinfection of accessories must be of a high level. The re-use of accessories labelled " for single use only " as a potential means to reduce costs has not been carefully evaluated, but should be allowed only if disinfection is effective (22).
A recent study was reported about the use of acidic electrolytic water potency for endoscope disinfection, safety for the tissues of the subject, and low cost (19 ).
As regards the time of contact between the disinfectant and the endoscope, not less than 1O minutes are recommended. Mechanical cleaning is the first and most important step, followed by high-level disinfection .The protection of the personnel is also important. Standards to prevent contact with infectious blood or body fluids must be maintained. Recent document on disinfection has been published on behalf of the ESGE (19).
Prophylactic antibiotics are recommended by ASGE (21) in patients with prothetic valves and surgically constructed systemic pulmonary shunts. For the British Society of Gastroenterology (16), it is also recommended when the patient is at a high risk of endocarditis, or of symptomatic bacteraemia as a consequence of immunosuppression or neutropenia. In most circumstances, parenteral Amoxicillline and Gentamycin are recommended. The addition of Metronidazole is needed in patients with neutropenia. Antibiotics prophlaxis is also recommended for all patients undergoing ERCP with evidence of biliary stasis or pancreatic pseudo-cyst ( 22 ).

  1. ENDOSCOPIC SEDATION AND MONITORING
    The goal of preparation for all endoscopic procedures should be to make a safe, comfortable, accurate and complete examination. A reassuring confident attitude on the part of the examiner and technical assistants and a calm, educated and motivated patient contribute to an optimal examination.

a) Sedation : consists in reducing the level of consciousness induced by medications used to facilitate acceptance of endoscopic procedures and to increase the comfort and safety of the examination (2). Benzodiazepines are the most commonly used agents in endoscopy and the most frequently prescribed drugs are Diazepam and Midozolam. Analgesia is almost associated, induced by the use of medications primarily opiates. Intravenous sedation is certainly worth recommending, especially for therapeutic endoscopic procedures ; however, it has been clearly shown that it carries significant risks ( 26, 33).
b) Monitoring : ( 27,29) is mandatory and prudent, and consists in the continuous assessment of the patient’s status, before, during, and after the administration of sedatives. It improves the outcome, by decreasing the risks of sedation and of the procedure, and should detect early signs of patient distress, before compromise to vital functions occurs. Most endoscopists are currently employing electronic monitoring equipment , but the best monitors of a patient’s safety are the physicians and skilled assistants working as a team. Nothing replaces clinical assessment, and it is important to underline that the ultimate responsibility for protecting patients lies with the endoscopist and cannot be assigned to an assistant or an electronic monitoring device.
However, both may greatly improve the ability to detect patient distress in time , when intervention will prevent an otherwise adverse outcome.
Emergency assistance, as well as transport to local intensive care units should be readily available. Whenever possible and appropriate the cooperation of an anesthesiologist will avoid a lot of problems and reduce the responsibilities of the endoscopist .
c) Standard clinical monitoring should include heart rate, blood pressure and respiratory rate, before sedation, during the procedure and immediately after , as well as before discharge from the recovery area. Oxymetry is useful for detecting decrease in oxygen saturation which usually carries little clinical risk. Continuous electrocardiographic rhythm is also used. Devices are now available to monitor all these parameters.
d) Out patient and sedation :
The standard practice as documented by multiple surveys ( 25, 27) is to carry out digestive endoscopy as a routine on an outpatient basis. It is also important to note that one half of the world regards upper G.I endoscopy without sedation as being the norm , and some authors suggest that endoscopy without sedation should be encouraged for routine examinations ( 32). The safety aspects point strongly to increased use of topical pharyngeal anesthesia and the reduction in the use of sedation ( 24). The use of throat spray for diagnostic endoscopy is quite acceptable to patients in routine diagnostic uppergastrointestinal endoscopy as it improves tolerance and facilitates examination (28, 29).
In fact, the vast majority of endoscopic procedures can be performed without sedation ( 32).

  1. PRACTICE AND DUTIE
  1. PERSONAL DUTIES
    The physician-patient relationship is usually entered into implicitly and consensually. The endoscopist has to be diligent with his patient, and to do the procedure with consciousness, prudence, and in accordance with the endoscopic standards of care. But it is imperative to know when his duty begins and ends and to be clear as to his role in the management of the patient.
  2. EXPANDED DUTY
    The physician endoscopist must be aware that as his role expands, so do his duties and legal responsibilities, because he assumes several roles which may lead to vicarious liability, which is the extension of liability from a party who is negligent to a second party who has had nothing to do with the negligent act ( 34 ). Vicarious liability from the wrongs of others, must be considered, but varies with the physician’s level of involvement in the care of each patient (34) :
    - As a consultant , it is the duty of the endoscopist to define whether he or the referring physician will be responsible for reevaluating the patient at a later date.
    - As a teacher,  he is responsible not only for his own negligent acts, but for those of his trainees.
    - As an employer, he may be liable for the mistakes of his personnel, and he has to demand a definitive level of professional behaviour from his employees.
    - As an administrator, he has duty to the patients who receive care in his unit, and the endoscopic practice must be within reasonable standards of care. This includes not only the level of endoscopic physician practice, but also that of the unit itself.
  3. PATIENT SURVEILLANCE :
    Screening of patients for potential medical problems is the duty of each physician, which will be limited or expanded, dependent upon the physician’s role in each patient’s health care. In the area of gastrointestinal disease, the majority of the guidelines published pertained to cancer detection and follow-up.
    If the physician endoscopist functions as the patient’s primary care physician, it is his duty to initiate early detection of cancer in asymptomatic people, and also to monitor surveillance of premalignant lesions of the upper G.I tract, colonic polyps, and colorectal cancer ( 33, 34 ). It is the duty of the physician to be familiar with the recommendations of the G.I Societies and to discuss these with his patient and document that discussion
  1. ENDOSCOPIC COMPLICATIONS, CLAIMS AND RISK
    MANAGEMENT
  1. COMPLICATIONS and bad results can and do occur in the normal course of endoscopy ( 41, 42, 43) It is acceptable to experience a complication which has nothing to do with the ( worth (  of the endoscopist. Several authors have attempted to establish the definition of complications and negative outcomes based on : life threating and residual disability ( 37 ) or on thresholds and grades ( 38 ).
    The complication rate of upper gastrointestinal endoscopy is about 0,1% , with cardiopulmonary events predominating. The typical complication of colonoscopy ,perforation, is seen in O, 2 %. The relevant ERCP specific complication is acute pancreatitis in about 1 %, followed by acute cholangitis ( 39, 4O ).
  2. ENDOSCOPIC CLAIMS : the risk of malpractice is real and unavoidable.
    Iatrogenic injury resulting from provider error is a common occurrence as the hospital care of medical and surgical patients. The rate is about 1 % : EGD and flexible sigmoidoscopy represent 8O % of the files, colonoscopy and pancreatobiliary procedures 1O % .The most common allegations associated with endoscopy are : improper performance (5O %) diagnostic error (25%), but perforation and post biopsy or post-polypectomy bleeding are the only endoscopic iatrogenic injury.
  3. RISK MANAGEMENT :
    consists in collecting and using data to minimize loss (443)
    Objectives are :

a) Define instances that place the endoscopist at risk
b) Determine the frequency and significance of these instances,
c) Apply risk treatment to individual cases,
d) Develop remedial and preventive measures.

There are several simple and easy risk techniques which can be incorporated into practice routine (47).

  1. Become familiar with the basics of tort law .
  2. Maintain a positive attitude in patient relationship.
  3. Clearly define the role and responsibility of the endoscopist
  4. Discuss fully complications which may or do occur
  5. Obtain written informed consent
  6. Document all aspects of the patient care
  7. Insure that the office staff is well-trained and interacts well with
    the patients.

The occurrence of complications is not malpractice per se, whereas the failure to make a timely diagnosis of the complication, may be. Documentation is the shield against malpractice claims.

  1. QUALITY ASSURANCE
    Designed to objectively and systematically monitor and evaluate the quality and appropriateness of care, pursue opportunities to improve patient care, and resolve identified problems, and must include   a plan that describes the programme’s objectives, organization, scope, and mechanisms for overseeing the effectiveness of monitoring, evaluation, and problem-solving activities.
    The major elements of a programme for quality assurance in G.I endoscopy are :
    Documentation with procedure reports, and endoscopic unit record. This includes the use of an appropriate terminology like the one defined by the OMED, and ESGE (3).
    Procedure review including :
    appropriateness of indications (45, 46 ), and absence of contra-indications. In any case an even wider statement of " reasons for " the procedure is advisable, possible, on precoded format (3).
    technical performance review.
  1. DOCUMENTATION :
  1. PREPROCEDURAL  : is mandatory and the most effective risk management tool available to the endoscopist once a medical malpractice issue arises. It should be complete, concise, and legal as discussed above.
  2. PROCEDURE REPORT : including patient identification, endoscopist, instrument and medications used (site, amount and time of administration) monitoring devices, anatomic extent of examination, tissue or fluid samples taken, findings, results of any therapeutic intervention, photographs or video-recorded if any, complications, diagnostic impression, recommendations, disposition and follow-up. Again it is important to comply with an agreed system, like the one acknowledged by ESGE (3).
  3. POST-PROCEDURE DOCUMENTATION : must record the patient’s vital signs. Follow-up instructions should be given to patient about driving, activity, medications. A contact emergency phone is also strongly advised.
  4. COMPLICATIONS : if one occurs, it should be documented in the record : what happened, how it happened, the patient’s response in terms of symptoms and vital signs, the actions taken by the endoscopist, and any further actions required.
  5. MAINTENANCE OF THE MEDICAL RECORD : confidentiality maintenance is the duty of the physician and his staff.
  1. PROCEDURE REVIEW
  1. INDICATION OF THE ENDOSCOPY :
    Will be discussed. Is endoscopy the best tool for diagnosis and therapy ? Independent judgement of the indication may lead to a decision against performing endoscopy. When the endoscopist hesitates about an indication he has to ask other colleagues and discuss with them the opportunity of the examination. The decision to perform a diagnostic procedure must take into account the probability and net benefit of identifying or discarding significant disease . In contrast the decision not to perform the procedure must evaluate among other elements, the risk of not detecting a significant disease. Ideally, the use of appropriateness criteria should result in improved patient outcomes as measured not only by morbidity and mortality, but also by quality of life, satisfacti