In May 2018, the FDA released a report titled "FDA Report on the Quality, Safety and Effectiveness of Servicing of Medical Devices," issued by the Secretary of Health and Human Services and in accordance with The Food and Drug Administration Reauthorization Act (FDARA). The FDA examined product servicing by manufacturers, healthcare establishments and third-party providers who refurbish, recondition, rebuild, remarket, service and repair medical devices.
The research was evaluated from information presented at a public workshop/meeting, responses to a request for comments, and the evaluation of objective evidence related to the quality, safety and effectiveness of medical device servicing.
Important key findings:
- "The objective evidence indicates that many OEMs and third party entities provide high quality, safe, and effective servicing of medical devices, and
- The continued availability of third party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system."
The conclusions above validate the importance of third-party entities, like Novasyte, to provide quality, field technical services on medical device products at every stage of the product lifecycle.
As a result of these findings, the FDA confirmed there is no objective evidence or need to impose additional regulatory requirements at this time in order to keep patients safe, as all parties are taking the necessary steps to maintaining quality products. With that said, they have outlined the following action items the FDA will be taking:
- "Promote the adoption of quality management principles by medical device servicers;
- Clarify the difference between servicing and remanufacturing;
- Strengthen cybersecurity practices associated with servicing of medical devices;
- Foster evidence development to assess the quality, safety, and effectiveness of medical device servicing; and
- Establish 'Collaborative Communities' where public and private sector members can work together to solve challenges associated with delivering high quality, safe and effective servicing of medical devices."
"In alignment with action item 1 above, here at Novasyte we pride ourselves in having the highest-quality teams and a quality management system that is ISO 9001:2015 certified," said Joe Andrew, SVP of Operations and Quality. "Defined service processes executed by highly-trained teams is not only imperative for producing accurate results for patient safety, but it can also impact the ongoing effectiveness of many devices. Our commitment to quality allows us to provide field technical support services that have repeatable results and real-time reporting - two key factors that drive our ongoing client satisfaction net promoter score of 81."