Hundreds of pages of comments submitted ahead of workshop
The Food and Drug Administration (FDA) has announced a public workshop entitled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers.” The topics to be discussed are the current regulatory environment for these activities, the definitions of the various terms FDA proposed in its prior Federal Register notice on this subject, and whether these activities should appropriately be regulated by FDA or a non-governmental organization.
The Food and Drug Administration’s call for public comments on March 4, 2016, regarding this topic generated hundreds of pages of comments from individuals, indepentdent service organizations (ISOs), industry associations and original equipment manufacturers (OEMs). The comments are available online at https://www.regulations.gov/document?D=FDA-2016-N-0436-0001.
FDA said it took this action, in part, because various stakeholders expressed concerns about the quality, safety, and continued effectiveness of medical devices that have been subject to one or more of these activities. The docket asked that OEMs, ISOs, health care establishments and third-party entities review proposed terms and definitions and provide edits if applicable. The docket also sought insights into basic concepts with regard to these activities.
Comments submitted to the FDA include concerns regarding competition, the cost of health care in the United States, patient safety and more.
“In conclusion, while I think the FDA needs to analyze its policies on a regular basis in order to insure safety to U.S. citizens, there is no clear reason for this other than stakeholders have initiated this process for perhaps their own financial gain,” writes Thomas G. Green, Owner/President, Paragon Service. “Without refurbishers or ISOs in the US providing high quality products and services at lower costs charged by the manufacturers, costs would be substantially higher and quality would be less. I encourage the FDA to embrace the great work that is done by the refurbishers and ISOs in this country and the essential role they play in cost containment and safety.”
GE Healthcare’s comments address safety and effectiveness of medical devices.
“Under the current regulatory framework, original equipment manufacturers are responsible for ensuring that the devices they put on the market are both safe and effective for their intended use. Furthermore as an OEM, GE Healthcare is committed to ensuring the continued safety and effectiveness of our devices after they are in commerce and in use,” the comments from GE Healthcare state. “In today’s healthcare environment, many organizations are involved in the servicing, refurbishing, remanufacturing and as-is remarketing of medical devices. Regulations related to third party entities range from minimal to none at all, a situation which by its very nature limits the amount of data available to assess the continued safety and effectiveness of devices in use by healthcare providers.”
Many comments focused on patient safety including those from Mark E. Bruley, ECRI Institute Vice President, Accident and Forensic Investigation.
ECRI came to a conclusion that patient safety is not being impacted in a negative manner by the current practices used to maintain medical equipment.
“Based on the results of the ECRI Institute’s detailed database searches spanning the past 10 years, and on its monitoring of medical device problems and hazards for more than 40 years, we do not believe that a safety problem exists with the servicing, maintenance, and repair of medical devices by either third-party organizations or OEMs,” the ECRI comments read.
AAMI President and CEO Mary Logan points out that regulation of medical device service, repair and maintenance is a hot topic in the comments and encourages all interested parties to participate in the upcoming FDA workshop.
“I was very pleased to see the mix of thoughtful responses in the approximately 170 comments that were submitted to the FDA. Sterilization professionals, clinicians, manufacturers, third-party repair companies, parts suppliers, ISOs, and HTM professionals all have different perspectives on the subject, and the FDA has heard from all of them,” Logan says. “Not surprisingly, some individuals and organizations are opposed to the idea of regulation, while others support greater FDA oversight. It’s clear that everyone in the community puts patient safety first and foremost, and that was affirming to see. I would encourage everyone who works with healthcare technology to participate in the upcoming FDA public workshop on October 27 and 28.”
The FDA says the purpose of the workshop is to convene interested parties to discuss regulatory aspects of third-party processes: refurbishing, reconditioning, rebuilding, remarketing, remanufacturing and servicing and address “Working Questions” that the FDA designed from the comments made to the docket, to promote understanding of challenges and best practices to mitigate risks associated with these activities.
The workshop will be held Thursday, October 27, 2016, from 8:30 a.m. to 5 p.m. and Friday, October 28, 2016 from 8:30 a.m. to 4 p.m. at the FDA White Oak Campus in Silver Spring, Maryland. Online registration to attend the workshop is available through the FDA website.
The meeting will be webcast (general sessions only). No registration is required for the webcast.
For additional information about the workshop, contact Felicia Brayboy by phone at 301-796-8086 or via email at Felicia.Brayboy@fda.hhs.gov.
