Some key issues that impact Central Sterile Supply Department professionals are garnering greater attention from the U.S. Food and Drug Administration (FDA), specifically, those dealing with the reprocessing of reusable medical devices and ways the agency can train FDA medical device reviewers to better assess device design and an instrument’s ability to be effectively cleaned.

This level of heightened attention by the FDA should come as little surprise to CSSD professionals. After all, the agency has been increasingly vocal in its desire to assume a more active role in medical device related issues, particularly those that pertain to device instrument processing. This push by the FDA to expand its involvement in such areas comes in light of highly publicized incidents surrounding patient exposure to contaminated equipment.

September 26, 2011, marked the deadline for public comments to the FDA on federal regulations dealing with the reprocessing of reusable devices; IAHCSMM submitted detailed, thorough comments on the issue. The push for the regulations stemmed from what the agency described as “an ongoing effort to address patient exposure to inadequately reprocessed reusable medical devices.” The FDA published a notice for public comment July 28 in the Federal Register and asked for input on “reprocessing quality, device design as it relates to the reprocessing of reusable medical devices, reprocessing methodologies, validation methodologies and health care best practices.”

Further elevating its commitment to the issue, the FDA joined forces with the Association for the Advancement of Medical Instrumentation (AAMI), co-hosting the Medical Device Reprocessing Summit October 11-12, 2011, in Silver Spring, Md. The Summit built upon the FDA’s June 8-9, 2011, public meeting on the issue, and had representation from leaders from industry, regulatory bodies and associations; clinicians from health institutions; subject experts, patient safety officers; researchers and others to identify, discuss and formulate strategic initiatives and priorities to improve the safe reprocessing of reusable medical devices. Kicking off the Summit was a presentation on “Defining ‘Clean’” – a session that, among other things, aimed to identify key factors for consideration when defining “clean” for handling and further reprocessing, and pinpoint the greatest challenges to end user verification of the manufacturer-recommended device cleaning processes.

The Summit also targeted “Design Issues with Reusable Medical Devices,” identifying design features the present challenges to reprocessing and needed manufacturing design improvements to facilitate better reprocessing. Other session topics included Human Factor Considerations in Reprocessing Procedures and Instructions; “Competency Requirements for Reprocessing Staff; Reprocessing Standards Activities; Considerations for Selecting Test Soils and Evaluating; Standardized Reprocessing Requirements and Terminology and Establishing Action Plans and Deliverables from the Summit.

Review process overhaul underway

Moving forward, medical device design may be more closely evaluated now that the Reviewer Certification Program, which began as a pilot in April 2010 with participants from the Center for Devices and Radiological Health’s Division of Anesthesia, General Hospital, and Infection Control and Dental Devices, has officially launched (the program will include all new device reviewers).

The program includes up to 18 months of training, aimed at complementing the skills and knowledge that new reviewers bring to CDRH from fields such as biomedical engineering and health care. Reviewers in the program will complete online training modules, instructor-led courses, and obtain practical experience in the medical device review process. Courses include medical devices, food and drug law and regulatory requirements, the CDRH review process, device design, and the impact of human factors.

“We are investing resources so that new device reviewers at CDRH are equipped to handle the range of issues that arise during the premarket device reviews,” noted CDRH director Jeffrey Shuren, M.D. “This investment will improve the quality of submission review and make the process more consistent and predictable.”

CDRH is also developing a pilot Experiential Learning Program for premarket reviewers. The program will include visits to academic institutions, manufacturers, research organizations and health care facilities, and is intended to give reviewers a better understanding of how medical devices are designed, manufactured and used. The program will also help new medical device reviewers understand the challenges of technology development and the impact of medical devices on patient care.

“Providing our review staff with opportunities to experience medical device development and use from outside the agency will provide new reviewers with a broader view of the regulatory process for medical devices,” Shuren said. The Experiential Learning Program is in the design stage and scheduled to begin as a pilot program in 2012.

Enhancing staff training is one of the 25 action items listed in the FDA’s Plan of Action for Implementation of 510(k) and Science Recommendations announced earlier this year to increase the predictability and transparency of regulatory pathways, and to strengthen the 510(k) process. The 510(k) is the most common pathway to market for medical devices.