Warning that continuing infection control lapses are endangering patients, the CDC and the FDA recently issued a joint alert calling for healthcare facilities to review policies and practices in cleaning and processing reusable medical devices.
“Recent infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety,” the agencies said in a health advisory issued Sept. 11.1 “Healthcare facilities (e.g., hospitals, ambulatory surgical centers, clinics, and doctors’ offices) that utilize reusable medical devices are urged to immediately review current reprocessing practices at their facility to ensure they are complying with all steps as directed by the device manufacturers, and have in place appropriate policies and procedures that are consistent with current standards and guidelines.”
The agencies cited recent reports of patients being notified that they might be at increased risk for infection due to lapses in basic cleaning, disinfection, and sterilization of medical devices. These events involved failures to follow manufacturers’ reprocessing instructions for critical (e.g., surgical instruments) and semi-critical items (e.g., endoscopes). (Editor’s note: A story in the October 2015 issue of Same-Day Surgery, “Scopes still contaminated after cleaning, study shows,” explained how bacteria can survive on endoscopes, despite a multi-step cleaning and disinfecting process.)
The advisory did not cite specific incidents, but the problem is chronic and is in evidence frequently in the media as healthcare facilities reach out to patients and warn them of possible exposures. There have been outbreaks of carbapenem-resistant Enterobacteriaceae linked to duodenoscopes, which are notoriously difficult to clean and disinfect.
In a follow-up statement, the CDC and FDA rescinded the following recommendation: If healthcare facilities contract maintenance and repair of these devices to third-party vendors, healthcare facilities should verify that these vendors are approved or certified by the manufacturer to provide those services. “We are making this change because there are currently no formal standardized programs or processes through which all manufacturers certify third-party vendors,” the agencies said in the statement. “We are also further clarifying that healthcare facilities which hire contractors to perform device reprocessing should verify that the contractor has an appropriate training program (i.e., consistent with what would be required in the healthcare facility) and that the training program includes the specific devices used by the healthcare facility.” (View the update at http://1.usa.gov/1JPcaPs.)
The FDA ordered the three manufacturers of duodenoscopes marketed in the United States to conduct post-market surveillance studies to better understand how the devices are reprocessed. The manufacturers — Olympus America, Fujifilm Medical Systems, U.S.A., and Hoya Corp. (Pentax Life Care Division) — were given 30 days to submit post-market surveillance plans to the FDA. These proposals must detail their plans to conduct studies to evaluate, among other things, how well healthcare personnel are following instructions to clean and disinfect duodenoscopes between patients and to better understand the rate of contamination of clinically used duodenoscopes.
The Joint Commission recently said that standards related to “infections with equipment/devices/supplies” are among those with the highest noncompliance for the first half of 2015 for ambulatory facilities, hospitals, and office-based surgeons. (For the entire list, go to http://bit.ly/1U6QRUN.)
Recent examples of questionable practices cited by the CDC in published reports2 include the following:
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The Bellevue Clinic and Surgery Center of Seattle Children’s Hospital notified some 10,000 patients this year they could be at risk for infection because of improperly cleaned surgical instruments going back to 2010.
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Last year, Pennsylvania authorities found that a surgery center failed to perform high-level disinfection of sigmoidoscope biopsy ports and to sterilize various forceps.
The CDC and FDA recommend that healthcare facilities arrange for a healthcare professional with expertise in device reprocessing to immediately assess their reprocessing procedures. This assessment should ensure that reprocessing is done correctly, including allowing enough time for reprocessing personnel to follow all steps recommended by the device manufacturers. In addition, other key recommended actions and interventions include the following:
• Training.
Healthcare facilities should provide training to all personnel who reprocess medical devices. Training should be required and provided, upon hire or prior to provision of services at the facility, at least once a year thereafter, and when new devices or protocols are introduced (including changes in the manufacturer’s instructions for use during the device’s life cycle).
Personnel should be required to demonstrate competency with device reprocessing (i.e., trainer observes correct technique) prior to being allowed to perform reprocessing independently. Healthcare facilities should maintain current documentation of trainings and competencies.
Copies of manufacturers’ instructions for operating and reprocessing each type of reusable device should be readily available to staff and inspectors. This file should include instructions for use of chemical disinfectants.
• Audits and feedback.
Healthcare facilities should regularly audit (monitor and document) adherence to cleaning, disinfection, sterilization, and device storage procedures. Audits should be conducted in all areas of the facility where reprocessing occurs. Healthcare facilities should provide feedback from audits to personnel regarding their adherence to cleaning, disinfection, and sterilization procedures. Audits should assess all reprocessing steps, including:
— performing prompt cleaning after use, prior to disinfection or sterilization procedures;
— using disinfectants in accordance with manufacturers’ instructions (e.g., dilution, contact time, storage, shelf-life);
— monitoring sterilizer performance (e.g., use of chemical and biological indicators, read-outs of sterilizer cycle parameters, appropriate record-keeping);
— monitoring automated endoscope reprocessor performance (e.g., printout of flow rate, time, and temperature; use of chemical indicators for monitoring high-level disinfectant concentration).
• Infection control policies and procedures.
Healthcare facilities should allow adequate time for reprocessing to ensure adherence to all steps recommended by the device manufacturer, including drying, proper storage, and transport of reprocessed devices. Considerations should be made regarding scheduling of procedures and supply of devices to ensure adequate time is allotted for reprocessing.
Facilities should have protocols to ensure that healthcare personnel can readily identify devices that have been properly reprocessed and are ready for patient use (e.g., tagging system, storage in a designated area).
Facilities should have policies and procedures outlining facility response in the event of a recognized reprocessing error or failure. Healthcare personnel should assess the cause of the error or failure and the exposure event in order to determine the potential risk of infection. The procedure should include how patients who might have been exposed to an improperly reprocessed medical device would be identified, notified, and followed.
Individuals responsible for infection prevention and reprocessing at the healthcare facility should be consulted whenever new devices will be purchased or introduced to ensure that infection control considerations are included in the purchasing decision as well as subsequent implementation of appropriate reprocessing policies and procedures and to ensure that the recommended reprocessing equipment is available at the healthcare facility.
Facilities should maintain documentation of reprocessing activities, including maintenance records for reprocessing equipment (e.g., autoclaves, automated endoscope reprocessors, medical washers and washer-disinfectors, water treatment systems), sterilization records (physical, chemical, and biological indicator results), and records verifying high-level disinfectants were tested and replaced appropriately.
Healthcare facilities should follow manufacturer recommendations for maintenance and repair of medical devices that are used to perform reprocessing functions as well as medical devices that are reprocessed. (See story in this issue with recommendations for bronchoscope reprocessing.)
REFERENCES
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CDC and FDA. Health Advisory. Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices. Sept. 11, 2015; accessed at http://emergency.cdc.gov/han/han00382.asp.
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Lowes R. Dirty reusable instruments also plague outpatient settings, CDC warns. Medscape Medical News. Sept. 11, 2015; accessed at http://www.medscape.com/viewarticle/850894.
