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Brief Summary

GUIDELINE TITLE

Reprocessing failure.

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

BRIEF SUMMARY CONTENT

 
RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

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*

Grade of Recommendation Clarity of Benefit Methodologic Strength/
Supporting Evidence
Implications
1A Clear Randomized trials without important limitations Strong recommendation; can be applied to most clinical settings
1B Clear Randomized trials with important limitations (inconsistent results, nonfatal methodologic flaws) Strong recommendation; likely to apply to most practice settings
1C+ Clear Overwhelming evidence from observational studies Strong recommendation; can apply to most practice settings in most situations
1C Clear Observational studies Intermediate-strength recommendation; may change when stronger evidence is available
2A Unclear Randomized trials without important limitations Intermediate-strength recommendation; best action may differ depending on circumstances or patients' or societal values
2B Unclear Randomized trials with important limitations (inconsistent results, nonfatal methodologic flaws) Weak recommendation; alternative approaches may be better under some circumstances
2C Unclear Observational studies Very weak recommendation; alternative approaches likely to be better under some circumstances
3 Unclear Expert opinion only Weak recommendation; likely to change as data become available

*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.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

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

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

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

DATE RELEASED

2007 Nov

GUIDELINE DEVELOPER(S)

American Society for Gastrointestinal Endoscopy - Medical Specialty Society

SOURCE(S) OF FUNDING

American Society for Gastrointestinal Endoscopy

GUIDELINE COMMITTEE

Standards of Practice Committee

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

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

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

Electronic copies: Available from the American Society for Gastrointestinal Endoscopy Web site.

Print copies: Available from the American Society for Gastrointestinal Endoscopy, 1520 Kensington Road, Suite 202, Oak Brook, IL 60523

AVAILABILITY OF COMPANION DOCUMENTS

None available

PATIENT RESOURCES

None available

NGC STATUS

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

COPYRIGHT STATEMENT

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

DISCLAIMER

NGC DISCLAIMER

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