John Davis Bell‚MD
John Davis Bell‚MD

It is with great pleasure that I introduce the new AACI clinical excellence standard relating to endoscopy care, and facility competence and excellence. For many years the issue of management and appropriate supervision of endoscope and other re-useable medical equipment (RME) requirements particularly relating to decontamination and reprocessing has mostly gone without questioning the realities involved in this most important area of patient care

In particular are the dangerous assumptions that infection control risks are minimal and that patient likelihood of falling victim to this hazard is remote. The figure of 1:1.8 million is often used to categorize the relative rate of infection associated with endoscopy procedures the current literature. However, there are some questions to be asked before this rate is accepted as valid.

1) Where did this figure come from and how was it generated? The answer is likely from 2006 in relationship to ENT procedures done in undefined populations with unspecified endoscope types and unknown sterilization or decontamination methodology. Even with this information it is difficult to imagine that the resulting conclusion relating to  infection rates is anything more than a statistical calculation. A wise man once said, “there three kinds of lies…lies, damn lies, and statistics.”

2) The real question here is what is the risk of infection associated with endoscopy given today’s clinical methodology in the general population? The unfortunate answer is “we don’t know.” We don’t know because of the variables involved. These variables include population, types of endoscopes used, methodology for decontamination and validation (if any) for these procedures, preservation of the decontaminated status of the instrument to the point of use, and most importantly, the availability of accurate and validated data from clinical sources providing this care.

In general, hospitals in the public sector are not eager to publish data which may impugn their failed processes for obvious reasons. However there is data from governmental hospitals in the US starting around 2010 and going forward to illustrate the potential risk of infections relating to improperly processed RME. The rate is alarmingly high and involves thousands of patients. This situation was not fully illuminated until congressional investigations and public outcry insisted. The positive aspect of this is that it focused some light on the myriad of issues  involved. The public awareness has contributed to public concern.

The question remains, what is the risk of infection associated with endoscopy in the general population? The answer is:  this depends on the patient, the validity of the decontamination process , the quality of the endoscope and its ability to be decontaminated effectively, the skill and knowledge of the personnel involved in these processes, and the dedication of the institution to monitor, measure, validate, analyze, correct, and improve on a continual basis. It also involves the training, skill, competence, and continuing education of practitioners, administrative management, and those involved with the environment of care.

In the end, we can assume that if you operate with a dirty tool, an infection is likely to result as pointed out above. We have ways to sterilize and assure the result of most RME, but owners of the central sterilization process in most hospitals will tell you that decontamination of flexible endoscopes is a much more difficult and elusive goal to achieve and to validate. Additionally, distribution and storage often spoils the successful cleaning effort. The need for effective control and a benchmark for establishing  quality processes relating to endoscopy service provision  is vital and overdue.

The AACI Standard on Endoscopy Excellence has been developed as a result of years of monitoring and evaluating endoscopy providers in the US, inclusive of  veteran, public health, and private healthcare institutions. Additionally providers  in the  EU have contributed to this compendium of knowledge. The Standard addresses and outlines the responsibilities incumbent upon institutions providing this care in a manner so as to insure positive outcomes. It is designed to accommodate individual and situational variability in  resources and intended scope of service. It provides a pathway for adhering to and developing new standards of care, the ability to document and validate excellence in all processes, and to continue the growth in customer satisfaction. It ensures the establishment of a safe setting for staff in the work place and for patient care.