First MedAccred Sterilization Pilot Audit Takes Place

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First MedAccred Sterilization Pilot Audit Takes Place

17 September 2015

Synergy Health plc facilities in Costa Rica have become the first company to pilot the MedAccred Sterilization audit criteria.

This follows the successful development of “Audit Criteria for Sterilization” (AC8113, AC8113/1 and AC8113/2) which includes “Radiation” (Electron Beam and Gamma) and Ethylene Oxide by the MedAccred Sterilization Task Group.  The members of the Task Group come from companies including DePuy Synthes, Philips HealthTech, Stryker, Baxter Healthcare, Becton, Dickinson & Co., DSM Biotech, Synergy Health and Flextronics. The Sterilization audit criteria draw from Industry Standards as well as the most common customer specifications.

Joe Pinto, Executive Vice President and Chief Operating Officer of PRI commented: “Being the first to pilot something new is not easy, but it is a vital part of the process. By volunteering to perform this essential function, Synergy Health plc is making a valuable contribution to MedAccred but more importantly, in the long-term, to the continual improvement of the industry as a whole, and to patient safety.”

Wendy Gould, VP Regulatory Affairs & Quality at Synergy Health plc said “We look forward to making it easier for our customers to do business with us, leveraging the MedAccred program will reduce their costs and improve audit consistency”.

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.

The data from the pilot audit will be used to validate the audit criteria, and make adjustments as needed, to ensure that it is a robust, relevant assessment tool that adds value for the medical device industry.

Benefits of MedAccred:

  • Provides consistent/standardized critical process accreditation accepted by 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
  • Medical device industry-accepted and consistent technical requirements leading to process discipline, greater operational efficiency and continuous improvement resulting in higher quality and lower overall cost