After considering feedback from vendors that perform servicing and repair of reusable medical devices, the Centers for Disease Control and Prevention (CDC) is amending an advisory it issued Sept. 11, 2015, to remove the following sentence:
“If health care facilities contract maintenance and repair of these devices to third-party vendors, health care facilities should verify that these vendors are approved or certified by the manufacturer to provide those services.”
The Department of Health (DOH) forwarded the updated advisory to all Pennsylvania physicians subscribed to receive alerts through its alert network.
“We are making this change because there are currently no formal standardized programs or processes through which all manufacturers certify third-party vendors, says the alert. “We are also further clarifying that health care 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 health care facility) and that the training program includes the specific devices used by the healthcare facility.”
According to the alert, health care facilities should arrange for a health care 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 manufacturer. The following actions should be performed:
- 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
- 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.
- Health care facilities should maintain current documentation of trainings and competencies.
- If the health care facility hires a contractor for device reprocessing, the facility should verify that the contractor has an appropriate training program (i.e., consistent with what would be required in the health care facility) and that the training program includes the specific devices the health care facility uses.
- 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.
- Training should be required and provided:
Audit and Feedback
- Health care facilities should regularly audit (monitor and document) adherence to cleaning, disinfection, sterilization, and device storage 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., print out of flow rate, time, and temperature, use of chemical indicators for monitoring high-level disinfectant concentration)
- Audits should be conducted in all areas of the facility where reprocessing occurs.
- Health care facilities should provide feedback from audits to personnel regarding their adherence to cleaning, disinfection, and sterilization procedures.
Infection Control Policies and Procedures
- Health care 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.
- Health care facilities should have protocols to ensure that health care 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).
- Health care 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.
- Health care 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.
- Health care 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
Education from PAMED Helps You Improve Infection Control
In an online, on-demand CME course from PAMED, you can:
- Gain knowledge concerning practicing effective infection control protocols to reduce transmission of infections
- Identify improvements needed with regards to current routine infection control practices
- Practice effective communication with a goal of reducing the potential for transmission of infections
- Establish appropriate standard precautions to decrease transmission of infections
- Recognize key infection control practices
- Formulate improvements associated with infection control to reduce transmission and improve the health of the patient
Pennsylvania physicians can purchase an infection control plan from PMSCO Healthcare Consulting, a subsidiary of PAMED, which can be customized and includes policies and forms for your practice. PAMED members receive a discount.