FDA, Medical Instrumentation Group Identify 7 Medical Device Reprocessing Priorities

The Association for the Advancement of Medical Instrumentation and the FDA hosted the 2011 Medical Device Reprocessing Summit to discuss challenges of reprocessing reusable medical devices.

AAMI and the FDA identified seven top priorities for promoting safe medical device reprocessing:

1. Define test soil more clearly and ensure its relevance to real-life situations. One of the goals under the test soil priority is to determine analytical endpoints and clinical relevance for soil types to be able to assess what level of soil could compromise sterilization and disinfection.

2. Create instructions for assessing whether the device is clean.
As many devices do not come apart, it is difficult to verify that lumens and crevices are clean, according to the document.

3. Develop standardized, simple instructions and processes that are repeatable.
AAMI and FDA wrote that instructions need to be simple, cost-effective and replicable by users with a broad range of skills.

4. Elevate reprocessing to the level we need it to be at. AAMI and FDA expressed a need to reeducate people on reprocessing constantly because of turnover and to respect people who do the reprocessing.

5. Write instructions for disassembly and reassembly. Devices should be designed to be cleaned from the beginning of the design process, the organizations wrote.

6. Clarify accountability of users and employers. AAMI and FDA identified a lack of clear standards and communication regarding reprocessing accountability.

7. Establish high-quality training and education standards.
Healthcare providers need to receive adequate training from manufacturers and should have standardized educational materials for correct medical device reprocessing, according to the AAMI and FDA.

Related Articles on Reprocessing:

Endoscope Reprocessing Guidelines Updated Following Infection Outbreaks
Ethicon Endo-Surgery to Acquire Reprocessor SterilMed

10 Important Steps for Sterile Processing in a Surgery Center

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