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New MedAccred Sterile Device Packaging Industry Accreditation
23 October 2019
The subscribers to the MedAccred program, Medtronic, Johnson & Johnson, Philips, Stryker, BD, Bayer, Baxter, and Boston Scientific, drove a fresh approach to overseeing Sterile Device Packaging suppliers to address this vital process that clearly impacts patient safety. After two years of rigorous development activity, the MedAccred program recently completed the new Sterile Device Packaging audit criteria. To support the initiative, Quality Tech Services, LLC (QTS) in Bloomington, Minnesota piloted the Sterile Device Packaging audit process and is expected to be the first company to achieve accreditation to Sterile Device Packaging in Packaging System Assembly/Filling and Sealing of trays.
The MedAccred team that focused on the development of the Sterile Device Packaging audit criteria and audit process is being led by Mischa Waas, Director Source Quality - Packaging Category, Johnson & Johnson. Other leading companies actively involved in the technical team were Medtronic, Stryker, Philips, BD, and Boston Scientific.
John Klapperich, Vice President of Operations at QTS highlighted the MedAccred audit process stating, “QTS has been audited many times by very experienced and knowledgeable auditors, but the MedAccred audit focused specifically on sterile barrier packaging processes was the most beneficial to enhancing this aspect of our business.”