New MedAccred Sterilization Audit Criteria

11 February 2020 The MedAccred Sterilization Audit Criteria for sterilization providers has recently been enhanced. The new Audit Criteria assesses a provider’s ability to conform at the highest level of assurance to the international standards for radiation sterilization (ISO 11137), ethylene oxide sterilization (ISO 11135), and the quality management systems requirements of ISO 13485. The audit documentation available to leading medical device companies utilizing the MedAccred Program (MedAccred Subscribers*) will provide a comprehensive record that will demonstrate supplier conformity to a rigorous critical processes audit. Sterilization experts from the leading sterilization and manufacturing companies, and also members of the AAMI/ISO sterilization standards committees, have combined their many years of experience in sterilization management to create the Audit Criteria.  Johnson & Johnson hosted the MedAccred working session to finalize the new Audit Criteria. Representatives from Johnson & Johnson, Boston Scientific, Medtronic, Stryker, BD, Straumann, Flextronics, Steris Isomedix Services, Sterigenics and Steri-Tek were joined by sterilization industry expert, Lisa Foster, the newest member of the MedAccred team to help guide and administer the MedAccred Sterilization program for the medical device industry. Kim Patton, Worldwide Sterilization Program Manager, Corporate Global Sterility Assurance, BD and MedAccred Industry Sterilization Chair lead the meeting and noted, “We have the top people in the industry fully engaged and now audit criteria that provides MedAccred Subscribers with supporting evidence of oversight.  It’s exciting to see the progress made in the last 2 years and 2020 should be a busy time for the Sterilization Task Group.” Lisa Foster explained, “When I first joined the MedAccred team, I immediately saw an opportunity to enhance the rigor of the assessment in order to provide accreditation of sterilization providers beyond reproach by regulators and notified bodies. The new MedAccred Sterilization Audit Criteria has definitely met my goal to increase the rigorousness of the audit process and focuses the audit process on every requirement in these standards.”