(You are encouraged to copy and distribute this information)
September 10, 1999
To: Director, Hospital Risk Management
Director, Hospital Administration
Director, Ambulatory Surgical Centers
Director, Infection Control
Director, Surgical Services/Operating Room
All Practitioners Who Use Bronchoscopes or Other Flexible Endoscopes
All Practitioners Who Use Automated Endoscope Reprocessors
This is to alert you to several incidents in which patients developed serious infections after being examined with bronchoscopes that apparently were inadequately reprocessed in an automated endoscope reprocessor (AER) and to provide recommendations that may help to reduce future incidents. FDA and CDC recognize the benefit of endoscopy as a medical procedure, but both agencies are concerned that endoscopes be properly prepared for patient contact.
Nature of Problem
In a recent publication titled "Bronchoscopy-related infections and pseudoinfections New York, 1996 and 1998" (MMWR 1999; 48(26); 557-560), CDC reported apparent patient-to-patient transmission of infections following bronchoscopic procedures that used bronchoscopes that were inadequately reprocessed by AERs. Investigation of the reported incidents revealed that:
FDA also is aware from its Medical Device Reporting (MDR) program that some users are using AERs to reprocess endoscopes that should not be processed in AERs. This practice may have resulted in damaged endoscopes and also raises questions about whether such processing results in an endoscope that is properly prepared for patient contact.
Manufacturer Labeling for Endoscopes and AERs
Endoscope users should be aware that FDA requires certain information in the labeling of these devices. Since 1996, the Agency has requested manufacturers of reusable medical devices to recommend at least one reprocessing method in their device labeling. The level of reprocessing should be based on the devices contact with the patient and the risk for disease transmission. Generally, endoscope manufacturers provide manual reprocessing instructions for each endoscope model. Following these instructions should result in endoscopes that are patient-ready.
FDA has also requested that the labeling of the AER include instructions for reprocessing specific models of endoscopes. The instructions should be based on the results of validation studies with the specific endoscope models. The 1993 FDA guidance for AER manufacturers recommended that the AER labeling:
Recommendations
We recommend that healthcare facilities responsible for preparing endoscopes for patient contact do the following:
- Visual inspections of the equipment to identify conditions that may affect the cleaning or disinfecting processes.
- Assurance that all manufacturer-recommended maintenance schedules and services are performed for endoscopes and AERs used in your facility.
- Use of appropriate process monitors as recommended by your AER and germicide manufacturers.
- Records of the use of each endoscope, showing the patient upon whom it was used, the type of procedure involved, and the system used to reprocess the endoscope.
- A surveillance system capable of detecting clusters of infections or pseudoinfections associated with endoscopic procedures.
Reporting adverse events
FDA is interested in additional data on adverse events involving the use of endoscopes and AERs. Healthcare professionals employed by healthcare facilities that are subject to FDAs user facility reporting requirements should follow the reporting procedures established by their facilities. The reports can be submitted by phone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; via the MedWatch website at www.fda.gov/medwatch; or by mail to: MedWatch, FDA, HF-2, 5600 Fishers Lane, Rockville, MD 20857.
Getting more information
Questions regarding this advisory can be e-mailed to phann@cdrh.fda.gov; faxed to Merrith Wilson at 301-594-2968; or submitted in writing to Merrith Wilson at FDA, CDRH, Office of Surveillance and Biometrics at 1350 Piccard Drive, Mail Stop HFZ-510, Rockville, MD 20850.
All of FDAs medical device postmarket safety notifications can be found on the
World Wide Web at http://www.fda.gov/cdrh/safety.html.
Postmarket safety notifications can also be obtained through email on the day they are
released by subscribing to our list server. To subscribe, visit:
http://service.govdelivery.com/service/subscribe.html?code=USFDACDRH_10
Sincerely yours,
David W. Feigal, Jr., MD, MPH Director Center for Devices and Radiological Health Food and Drug Administration |
James M. Hughes, MD Director National Center for Infectious Diseases Centers for Disease Control and Prevention |
Suggested Reading and Sources of Additional Information
Agerton T, et al. Transmission of a highly drug-resistant strain (strain W1) of Mycobacterium tuberculosis. JAMA 1997; 278:1073-77.
American Society for Testing and Materials (ASTM): F1518-94 Standard practice for cleaning and disinfection of flexible fiberoptic and video endoscopes used in the examination of the hollow viscera. Vol. 13.01 Medical Devices. Annual Book of ASTM Standards 1998: 834-39 (their website is http://www.astm.org/).
Bennett SN, et al. Bronchoscopy-associated Mycobacterium xenopi pseudoinfections. Am J Resp Crit Care Med 1994; 150:245-50.
Blanc DS, et al. Nosocomial infections and pseudoinfections from contaminated bronchoscopes: two-year follow-up using molecular markers. Infec Control Hosp Epidemiol 1997; 18:134-36.
Bronowicki JP, et al. Patient-to-patient transmission of hepatitis C virus during colonoscopy. New Eng J Med 1997; 337:237-40.
Centers for Disease Control and Prevention. Bronchoscope-related infections and pseudoinfections-New York, 1996 and 1998. MMWR 1999; 48(26); 557-560. (A copy of this article can be downloaded from the CDC Web site at http://www2.cdc.gov/mmwr/.)
Deva AK, et al. Detection of persistent vegetative bacteria and amplified viral nucleic acid from in-use testing of gastrointestinal endoscopes. J Hosp Infec 1998; 39:149-57.
ECRI: Recommended protocol for reprocessing immersible flexible endoscopes. Health Devices 1999; 28(5-6): 178.
FDA, Center for Devices and Radiological Health. FDA Reviewer Guidance: Labeling reusable medical devices for reprocessing in health care facilities. (A copy of this document can be obtained from CDRHs Facts-on-Demand system by calling 1-800-899-0381 from a touch-tone telephone. At the main F-O-D voice prompt, press #1 to access DSMA Facts, at the second voice prompt press #2 and enter document #198.)
Kovacs BJ, et al. High-level disinfection of gastrointestinal endoscopes: are current guidelines adequate? Am J Gastroenterol 1999; 94:1546-50.
Maloney S, et al. Mycobacterium abscessus pseudoinfection traced to an automated endoscope washer: utility of epidemiological and laboratory investigation. J Infect Dis 1994; 169:1166-69.
Martin MA, et al. APIC guideline for infection control in flexible endoscopy. Am J Infect Control 1994; 22(1): 19-38.
Rutala WA. Disinfection and sterilization of patient-care items. Infect Control Hosp Epidemiol 1996; 17:377-84.
Society of Gastroenterology Nurses and Associates (SGNA). Endoscope cleaning and high level disinfection self study module, SGNA, Inc.
Updated September 10, 1999
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