Solar Atmospheres Inc., Souderton,Pa., announces that it has become the first company to receive MedAccred critical process re-accreditation. Furthermore, the company expanded its scope of accreditation to include Hardness Testing and Metallography & Microindentation Hardness. MedAccred is an industry-managed critical process supply chain oversight program developed by leading medical device companies to improve device quality and enhance patient safety.
The effort to establish MedAccred began in 2010 when the Performance Review Institute (PRI) was asked to consider the development of a Nadcap style special process supplier accreditation program for the medical device industry.
An industry roundtable was organized and convened in 2012 among interested medical device companies and PRI. Following this roundtable meeting, briefings were held with the FDA Center for Devices and Radiological Health’s (CDRH) Office of Compliance and the FDA’s Office of Global Operations within the Office of the Commissioner. The program purpose and scope was discussed, along with the results of proof of concept audits conducted to demonstrate the program’s viability. The FDA provided positive feedback and strong encouragement to pursue the development of the program.
By 2014, several critical process Task Groups were operating on a formal basis. Program documents were drafted, circulated, and approved by the executives of the participating companies, and audit criteria had been published in several critical process areas. Solar Atmospheres committed to hosting the first MedAccred audit. In early 2015, the first MedAccred critical process accreditation was issued to Solar Atmospheres or Heat Treating.
Today’s functioning critical process Task Groups include Cable & Wire Harnesses, Heat Treating, Plastics Injection Molding, Printed Circuit Board Assemblies, Sterilization, and Welding. The industry-managed task groups develop audit criteria, conduct audits, and award MedAccred Critical Process Accreditations to leading suppliers at all tiers in the Medical Device Supply Chain. Many companies are seeking MedAccred Accreditation to demonstrate their commitment to quality and patient safety.
Future MedAccred Task Groups under consideration for development include Material Testing Laboratories, Assemblies, PCBs, Batteries, Chemical Processing, NDT, Cleaning, Coating, Optics, and Packaging.
Active OEM and Contract Manufacturer participants include Johnson & Johnson, Philips, Stryker, GE Healthcare, Medtronic, NYPRO Jabil, Steris, etc. The list of participating suppliers is growing steadily.
