ALERT
Medical Devices

Date: 2000-11-01

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November 1, 2000 M.D.A. No. 114

To: Hospital Administrators

Attention: Hospital Risk Management, Infection Control, Surgical Services and Operating Room, Ambulatory Surgical Centres, Practitioners who use automated endoscope reprocessors

Subject: REVISION TO M.D.A. No. 112: Infections from Endoscopes Inadequately Reprocessed by Automatic Endoscope Reprocessing Units

Medical Devices Alert No. 112, issued on June 30, 2000, advised hospitals of the potential for serious infections from endoscopes that are inadequately decontaminated by an automatic endoscope reprocessing unit (AERU) and gave recommendations for reducing the risk of infection. Several health care professionals have pointed out that Recommendation 4 in Section A, "Choosing an AERU", does not apply to AERUs that use a reusable disinfectant. This was not clear from the text of the Alert. Therefore, please see the revised recommendations in Section A on page 2.

The US Centers for Disease Control and Prevention and the US FDA recently published reports¹,² on cases of apparent patient-to-patient infections following procedures with bronchoscopes that had been inadequately reprocessed by AERUs. The reports identified inconsistencies between the reprocessing instructions provided by the AERU manufacturer and the endoscope manufacturer and found that broncho-scopes were inadequately reprocessed when inappropriate channel connectors were used with the AERU.

The Health Products and Food Branch is also aware of instances where health care facilities have identified growth of pathogenic organisms in critical components of the AERU even when recommended AERU maintenance had been followed.

Recommendations

The Health Products and Food Branch recommends that health care facilities that reprocess endoscopes take the following precautions.

A. Choosing an AERU

Before you purchase an AERU, make sure that it meets the following criteria:

• the AERU is licensed for sale in Canada
  
  
• there are no potential reservoirs of infections - areas in the AERU where water or disinfectant can stagnate
  
  
• the AERU can effectively irrigate all channels of any endoscope to be processed in the AERU, ensuring effective contact between the chemical disinfectant and the channel walls
  
  
• for wash cycles ensure that all wash fluids (water and chemicals) are completely drained and discarded following each wash cycle ensuring that there are no potential reservoirs of infections (areas in the AERU where water can stagnate) and reuse of contaminated wash fluid is not possible
  
  
• for the disinfection cycle, ensure that water and chemicals are completely drained between cycles:
  
  If the AERU uses a single-use disinfectant ensure that the disinfectant is completely drained and discarded after each cycle.
  
  If the AERU uses a reusable disinfectant, ensure that the minimum effective concentration (MEC) is monitored daily using test strips available from the supplier of the disinfectant. Discard the disinfectant in accordance with local regulations at the end of the disinfectant's specified reuse life (as specified by the disinfectant supplier) or following a failed MEC test, whichever comes first.
  
  
• the cycle length can be adjusted to correspond with the type of endoscope and its intended use, to ensure high-level disinfection or sterilization
  
  
• the manufacturer of the AERU identifies by brand and model each endoscope that may be effectively reprocessed in the AERU and the limitations of the AERU in processing certain models of endoscopes and accessories.
  
  

B. Cleaning and Reprocessing Procedures

1. Ensure that the cleaning and reprocessing procedures used by the staff are current and effective. Use the guidelines developed by the Canadian Society of Gastroenter-ology Nurses Association³ and the US Society of Gastroenterology Nurses Association ⁴ to evaluate the reprocessing recom-mendations received from AERU manufacturers and endoscope manufacturers.

2. Ensure that all staff who handle soiled endoscopes are fully trained to handle and clean endoscopes in accordance with the endoscope manufacturer's specific instructions for each brand and model. Ensure that the written procedures are being followed exactly.

3. The following steps are critical regard-less of whether your facility manually reprocesses the endoscopes or uses an AERU.

• Flush the endoscope immediately after every procedure.
  
  
• Before any automated or manual disinfection or sterilization procedure:
  
  
  1. clean the endoscope manually, meticulously removing all organic material in or on the endoscope; and
  2. rinse all parts and lumens thoroughly with copious amounts of water and dry them before placing the scope in the reprocessing unit. This drying step avoids dilution of the disinfectant concentration or interaction between the water and the sterilant.

4. Follow your endoscope manufacturer's directions for reprocessing that specific brand and model. Check with the manu-facturer of the endoscope to determine that the specific brands and models of endo-scopes you use can be reprocessed in an AERU and whether specific steps are re-quired for automated reprocessing. Not all endoscopes can be reprocessed using an AERU.

5. If some brands and models of endoscopes used in your facility are not specifically indicated in the AERU labelling, ask the manufacturer of the AERU if these endoscopes have been tested with the AERU.

6. Be sure to reconcile any differences in processing recommendations between the endoscope manufacturer, the AERU manufacturer and the manufacturer of the disinfectant, particularly with respect to the instructions for the use of channel connectors or capping of specific channels.

7. In the absence of detailed written instructions for processing the specific model of endoscope, the endoscope must be reprocessed manually.

8. Regardless of whether you manually reprocess or use an AERU, incorporate a final drying step in your reprocessing protocol; flush all channels with alcohol, followed by purging of channels with air to remove the alcohol (see American Society for Testing and Materials Standard F1518-94).

9. Implement a comprehensive quality assurance program.

Your QA program should include:

1. Visual inspection of the reprocessing procedure and reprocessed endoscopes to identify conditions that may affect cleaning and disinfection processes.
   
   
2. Assurance that all manufacturers' recommended maintenance schedules for endoscopes and for AERUs are performed.
   
   
3. Use of appropriate process monitors for the disinfectant in the AERU or in manual basins.
   
   
4. Records of the use of each endoscope, showing the patient upon which it was used, the type of procedure and the reprocessing process and unit used.
   
   
5. Regular review of the training given to reprocessing staff, including additional staff training and supervised practice each time a new endoscopy model is introduced into the facility.
   
   
6. A surveillance system capable of detecting clusters of infections or pseudo-infections associated with endoscopic procedures.
   
   

Reporting Adverse Events

Reports of adverse incidents involving the use of endoscopes and AERUs and inquiries concerning this Alert may be made by calling the toll-free Medical Devices Hotline at 1-800-267-9675, or by contacting:

The Director,
Medical Devices Bureau,
Room 1605,
Main Statistics Canada Building,
Tunney's Pasture, A.L. 0301H1,
Ottawa, Ontario, K1A 0L2
Tel: 613-957-4786, fax: 613-957-7318

Diane Gorman
Assistant Deputy Minister

References: