Synergy Health in Alajuela, Costa Rica has become the first company to receive MedAccred sterilization accreditation, on January 5, 2016.
This follows the successful development of the MedAccred Audit Criteria for Sterilization by the MedAccred Sterilization Task Group (AC8113, AC8113/1 and AC8113/2). The audit criteria include Radiation (Electron Beam and Gamma) and Ethylene Oxide. The members of the Task Group come from companies including Johnson & Johnson, Philips, Stryker, Baxter Healthcare, Becton, Dickinson & Co., DSM Biotech, Synergy Health and Flex. The Sterilization audit criteria draw from Industry Standards as well as the most common customer specifications.
MedAccred is an industry managed supply chain oversight program that bolsters patient safety. It does this through clarification of requirements and better identifying how they apply to critical processes used in the production of medical devices.
Sterilization is just one area for MedAccred: there is also activity in other critical process areas such as Cable and Wire Harness, Heat Treating, Plastics, Printed Circuit Board Assemblies, and Welding.
Benefits of MedAccred:
Provides consistent/standardized critical process accreditation accepted by leaders in the Medical Device Industry resulting in fewer redundant onsite audits by multiple OEMs
Conducts in-depth critical process audits that are compliant and consistent to accepted industry/technical standards and conducted by Subject Matter Experts
Provides 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.)
Improves flow down of OEM requirements to sub-tier suppliers