Guideline:
Reprocessing failure
Bibliographic Source(s)
- Standards of Practice Committee Banerjee S Nelson DB Dominitz JA Ikenberry SO Anderson MA Cash BD Gan SI Harrison ME 3rd Shen B Baron TH Van Guilder T Lee KK. Reprocessing failure. Gastrointest Endosc 2007 Nov;66(5):869-71. [5 references] PubMed
Guideline Status
This is the current release of the guideline.
Guideline Category
Counseling
Evaluation
Management
Intended Users
Physicians
Public Health Departments
Guideline Objective(s)
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
Target Population
Patients undergoing endoscopy
Interventions and Practices Considered
- 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
- Notifying patient in a timely manner
- Early serologic testing including baseline testing for hepatitis B hepatitis C and human immunodeficiency virus (HIV) infection
- Patient counseling
- Repeat testing
Major Outcomes Considered
Not stated
Methods Used to Collect/Select Evidence
Hand-searches of Published Literature (Primary Sources)
Searches of Electronic Databases
Description of Methods used to Collect/Select the Evidence
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.
Number of Source Documents
Not stated
Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus (Committee)
Rating Scheme for the Strength of the Evidence
Not applicable
Methods Used to Analyze the Evidence
Systematic Review
Description of the Methods Used to Analyze the Evidence
Not stated
Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations
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.
Rating Scheme for the Strength of the Recommendations
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.
Cost Analysis
A formal cost analysis was not performed and published cost analyses were not reviewed.
Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation
This document was reviewed and approved by the Governing Board of the American Society for Gastrointestinal Endoscopy.
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)
- 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.
- 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.
- 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.
- A toll-free helpline should be established to provide information to all patients at risk.
- Patients should be advised against donating blood and tissue products and engaging in sexual contact without barrier protection until all serologic testing is complete.
- 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.
- 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.
- 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.
- 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
Type of Evidence supporting the Recommendations
The type of supporting evidence is identified for each recommendation (see "Major Recommendations").
Potential Benefits
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.
Potential Harms
- 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.
Qualifying Statements
- 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.
Description of Implementation Strategy
An implementation strategy was not provided.
IOM Care Need
Staying Healthy
IOM Domain
Patient-centeredness
Safety
Bibliographic Source(s)
- Standards of Practice Committee Banerjee S Nelson DB Dominitz JA Ikenberry SO Anderson MA Cash BD Gan SI Harrison ME 3rd Shen B Baron TH Van Guilder T Lee KK. Reprocessing failure. Gastrointest Endosc 2007 Nov;66(5):869-71. [5 references] PubMed
Adaptation
Not applicable: The guideline was not adapted from another source.
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.
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