This is the current release of the guideline.

Infections caused by a failure to appropriately reprocess endoscopic instruments

Counseling
Evaluation
Management

Family Practice
Gastroenterology
Infectious Diseases
Internal Medicine

Physicians
Public Health Departments

To provide recommendations for situations where breaches in high-level disinfection protocols have occurred and the risk of transmission of bacterial and viral infections is increased

Patients undergoing endoscopy

1. Reporting of reprocessing failure to the institution's designated infection control personnel, local and state public health agencies, the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, and the manufacturers of the involved equipment
2. Notifying patient in a timely manner
3. Early serologic testing including baseline testing for hepatitis B, hepatitis C, and human immunodeficiency virus (HIV) infection
4. Patient counseling
5. Repeat testing

Not stated

Hand-searches of Published Literature (Primary Sources)
Searches of Electronic Databases

In preparing this guideline, a search of the medical literature was performed by PubMed, supplemented by accessing the "related articles" feature of PubMed. Additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants. When little or no data exist from well-designed prospective trials, emphasis is given to results from large series and reports from recognized experts.

Not stated

Expert Consensus (Committee)

Not applicable

Systematic Review

Not stated

Expert Consensus

Guidelines for appropriate use of endoscopy are based on a critical review of the available data and expert consensus at the time the guidelines are drafted.

Grades of Recommendation*

*Adapted from Guyatt G, Sinclair J, Cook D, Jaeschke R, Schunemann H, Pauker S. Moving from evidence to action: grading recommendations—a qualitative approach. In: Guyatt G, Rennie D, eds. Users' guides to the medical literature. Chicago: AMA Press; 2002. p. 599-608.

A formal cost analysis was not performed and published cost analyses were not reviewed.

Internal Peer Review

This document was reviewed and approved by the Governing Board of the American Society for Gastrointestinal Endoscopy.

Recommendations were graded on the strength of the supporting evidence (Grades 1A-3). Definitions of the recommendation grades are presented at the end of the "Major Recommendations" field.

Recommendations (Level of Evidence Grade 3 for All)

1. When a breach of the high-level disinfection protocol is discovered, it should be reported to the institution's designated infection control personnel, local/state public health agencies, the Food and Drug Administration, the Centers for Disease Control and Prevention, and the manufacturers of the involved equipment.
2. Patients at risk should be notified directly of the breach in a timely manner and of the estimated risk of infection. Successful notification or attempts at notification should be documented.
3. Early serologic testing is imperative to distinguish prior infection(s) from those potentially acquired as a result of the breach in the high-level disinfection protocol. In cases where testing is delayed, it may be difficult to exclude the endoscopic procedure as a potential source of the infection.
4. A toll-free helpline should be established to provide information to all patients at risk.
5. Patients should be advised against donating blood and tissue products and engaging in sexual contact without barrier protection until all serologic testing is complete.
6. Personal counseling should be offered to all patients. The risk of infection should be discussed and placed in context to minimize patient anxiety. In addition, the possibility that the patient might previously have a chronic viral infection should be discussed, along with the role of testing in distinguishing preexisting from newly acquired infections.
7. Patients should be asked whether they developed new symptoms suggestive of transmission of enteric bacteria or viruses after the endoscopic procedure. Prior vaccination history for hepatitis A and B should be documented. If patients have undergone prior hepatitis B vaccination, postvaccination titers should be documented if they were measured. An attempt should be made to identify risk factors for hepatitis B, hepatitis C, and human immunodeficiency virus (HIV). If patients have previously undergone testing for these infections, the results should be documented.
8. Baseline serologic testing for hepatitis B, hepatitis C, and HIV should be performed. Patients should be informed about their baseline serology results in a timely manner.
9. Repeat testing, which may include serology and ribonucleic acid (RNA) tests, should be performed in all cases. The timing and the choice of tests will be influenced by the period of time that has elapsed between patient exposure and initial testing, by the presence or absence of patient symptoms, and by the advice of the institution's infectious diseases specialist. Institutions may consider obtaining follow-up testing at 6 weeks, 3 months, and 6 months post procedure. In some situations, additional follow-up testing may be advisable at 1 year post exposure.

Definitions:

Grades of Recommendation*

*Adapted from Guyatt G, Sinclair J, Cook D, Jaeschke R, Schunemann H, Pauker S. Moving from evidence to action: grading recommendations—a qualitative approach. In: Guyatt G, Rennie D, eds. Users' guides to the medical literature. Chicago: AMA Press; 2002. p. 599-608.

None provided

The type of supporting evidence is identified for each recommendation (see "Major Recommendations").

Prompt notification of a significant breach in reprocessing allows patients to take precautions to minimize the risk of transmitting infection to others and allows for early serologic testing. This may help distinguish chronic infections from those potentially acquired at the time of endoscopy and to permit earlier initiation of treatment for newly acquired infections.

• Notifying patients of reprocessing failure can cause unnecessary patient distress in a situation where the risk of infection may be very small.
• Adverse publicity associated with the reporting of a reprocessing outbreak might lead patients to avoid potentially life-saving endoscopic procedures because of an unwarranted fear of infection. This in turn could have deleterious health consequences for the community at large because many significant life- and health-threatening conditions may remain undiagnosed and untreated.

• Further controlled clinical studies may be needed to clarify aspects of this guideline. This guideline may be revised as necessary to account for changes in technology, new data, or other aspects of clinical practice.
• This guideline is intended to be an educational device to provide information that may assist endoscopists in providing care to patients. This guideline is not a rule and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment. Clinical decisions in any particular case involve complex analysis of the patient's condition and available courses of action. Therefore, clinical considerations may lead an endoscopist to take a course of action that varies from these guidelines.

An implementation strategy was not provided.

Staying Healthy

Patient-centeredness
Safety

Not applicable: The guideline was not adapted from another source.

2007 Nov

American Society for Gastrointestinal Endoscopy - Medical Specialty Society

American Society for Gastrointestinal Endoscopy

Standards of Practice Committee

Committee Members: Subhas Banerjee, MD; Douglas B. Nelson, MD; Jason A. Dominitz, MD, MHS; Steven O. Ikenberry, MD; Michelle A. Anderson, MD; Brooks D. Cash, MD; Seng-Ian Gan, MD; M. Edwyn Harrison III, MD; Bo Shen, MD; Todd H. Baron, MD, Chair; Trina Van Guilder, RN, SGNA Representative; Kenneth K. Lee, MD, NAPSGHAN Representative

Not stated

This is the current release of the guideline.

None available

None available

This NGC summary was completed by ECRI Institute on March 4, 2008.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.