Following up on last fall’s summit on medical device reprocessing, the Association for the Advancement of Medical Instrumentation (AAMI)—which co-sponsored the summit with the FDA—has released a 40-page summary of the event’s discussions and decisions.
Noting reports of patients infected by contaminated endoscopes, forceps and other devices, "Priority Issues From the AAMI/FDA Medical Device Reprocessing Summit" urged hospitals to “take action” with better policies and procedures.
“AAMI standards committees already are making plans and setting priorities on what can be addressed now and by whom. The FDA continues to seek out and capitalize on opportunities to improve the reprocessing of reusable medical devices through regulatory science,” wrote Mary Logan and Pamela D. Scott in the publication’s introduction. Logan is president of AAMI and Scott is the FDA’s senior science advisor on reprocessing medical devices.
The report laid out seven “clarion themes” that emerged at the Oct. 11-12, 2011 summit:
- Gain consensus on “how clean is clean” and on adequate cleaning validation protocols for reprocessing reusable medical devices.
- Create standardized, clear instructions and repeatable steps for reprocessing whenever possible.
- Pay early, iterative and comprehensive attention to reprocessing requirements throughout the device design process.
- Make human factors and work environment factors priorities when developing reprocessing requirements.
- Improve information collection and sharing to broaden the use of best practices in reprocessing.
- Improve reprocessing competencies by strengthening training, education and certification.
- Create a greater sense of urgency and understanding throughout the healthcare community about the consequences of inadequate reprocessing.
The report also offered 10 “immediate steps: hospitals and other provider facilities can take. These include making sure device manufacturers’ instructions for use (IFU) are readily available in all reprocessing areas, creating a multidisciplinary committee to set a plan for tackling the report’s priority issues throughout the organization and conducting an audit of compliance with standards and regulations.
“Working together, AAMI and the FDA will facilitate collaboration with other organizations, companies and individuals to take the lead on different areas of the reprocessing challenge,” wrote Logan and Scott. “No one group can do this alone, and the answer is not as simple as ‘more standards’ or ‘more regulations.’”
To read the report in PDF format, click here.