The Medical Device Innovation Consortium (MDIC) has released its Final Pilot Report evaluating the MedAccred® Sterilization Audit and Accreditation Program. The Final Pilot Report provides recommendations for FDA’s consideration regarding the potential use of MedAccred audit data in risk-based inspection planning and resource allocation. Coordinated by MDIC, the pilot study examined the program’s alignment with industry quality standards and its potential to enhance quality assurance within the medical device sector. Following the pilot study, MDIC found the MedAccred audit and accreditation program robust and comprehensive concerning the covered Sterilization processes combined with a thorough evaluation of the Quality Management System (QMS) requirements.

Developed and administered by the Performance Review Institute (PRI), MedAccred provides expert-led audits aimed at reducing redundant evaluations, optimizing resource use for original equipment manufacturers (OEMs), and improving operational efficiency for contract sterilizers. MedAccred provides consistent and standardized critical process accreditation accepted by the medical device industry resulting in fewer redundant onsite audits by multiple OEMs. This is achieved by conducting in-depth critical process audits that are compliant and consistent to accepted industry/technical standards and conducted by Subject Matter Experts while providing greater visibility of the supply chain to all levels and sub-tiers that provide critical processes, consistent with regulatory requirements (e.g., FDA, ISO 13485, MDD, etc.) Representatives from the FDA participated in the development of the report and offered insights on the potential of MedAccred audit data in risk-based inspection planning and resource allocation. An FDA representative involved in the study commented, “The audit was thorough and covered all critical areas of an EO sterilization process…I was impressed with the MedAccred audit.” Another noted, “The audit was conducted well, in an organized and logical approach…Technical issues such as validation gaps were given high priority.”

OEM subscribers, including Boston Scientific, Medtronic, and Stryker fund and manage the MedAccred program, demonstrating industry-wide collaboration in advancing quality and safety standards in medical technology. This collaborative effort is further reinforced by the findings of the Final Pilot Report, which highlights key benefits of the MedAccred Accreditation and Audity Program, such as reducing redundant audits, improving resource allocation for OEMs, and supporting product sterility and patient safety through comprehensive, expert-let assessments.