US working group formed to improve medical device quality
Representatives from the medical device industry, the U.S. government, and industry associations have formed a working group to identify and recommend best practices to improve medical device quality and enhance supply chain resiliency.
The purpose of the Best Practices in Supply Chain Resiliency and Quality Working Group is to improve medical device quality and supply chain resiliency by expanding MedAccred adoption through the tiers in the supply chain, identifying best practices to supplement efforts in quality assurance and procurement strategies, and to help mitigate supply chain risks. The working group will provide clear considerations for key stakeholders, including medical device OEMs and contract manufacturers, U.S. FDA, U.S. Department of Commerce, NIST (National Institute of Standards and Technology) Manufacturing Extension Partnership (NIST MEP), MedAccred, MedMMAP, Medical Device Innovation Consortium (MDIC), Notified Bodies, Homeland Security, and others.
As part of its efforts, the working group will seek and evaluate lessons learned from other industries including aerospace and automotive. A critical outcome will be to identify the highest value critical manufacturing processes in medical device development with the aim of implementing the MedAccred program to mitigate supply chain risk, reduce quality escapes and improve patient safety.
The new working group was inspired by the U.S. FDA Center for Devices and Radiological Health’s (CDRH) Case for Quality Initiative, which seeks to collaboratively advance the quality, safety, and effectiveness of medical devices to improve patient safety and clinical outcomes. The working group is being chaired by the MedAccred program, which is administered by the Performance Review Institute.
Bob Lizewski, vice president, MedAccred, chairman of the FDA Working Group, said: “This new working group brings together MedAccred, the FDA, U.S. Department of Commerce, and the medical device industry to improve quality, reduce supply chain risks and make best use of technology. By working together, we aim to review and adapt best practices from across the medical device industry and develop practical recommendations towards improving patient safety while also reducing the cost to business.”