By Robert Kerwin
IAMERS General Counsel
Shortly before the summer congressional recess, the U.S. Senate passed a bipartisan bill to reauthorize the FDA user fee programs. The Senate User Fee bill followed the House bill and was approved 94-1. President Trump’s spokesperson has announced that the president will sign the bill.
The legislation includes a provision important to hospitals and independent servicers. The provision requires the FDA to issue a report within 270 days of enactment on the continued quality, safety and effectiveness of the servicing of medical devices.
At RSNA 2019, Dunlee is announcing a new product development project to design CT replacement tubes for the next generation of GE CT scanners. The project promises to create an even broader portfolio of Dunlee CT replacement tubes. Read more>>>
The FDA report, which will be posted to its website, will also evaluate comments received from the docket opened by the FDA, as well as the two-day FDA workshop held in October 2016.
The FDA may issue the report in advance of the congressionally-imposed deadline, potentially as soon as next month, according to a reliable industry source who asked not to be named. Since the completion of the two-day workshop, the FDA, principally through a 10-person internal FDA work group, has been hard at work carefully evaluating the comments and testimony received, while also listening to many different stakeholders.
“We appreciate the FDA’s careful consideration of device servicing. We are grateful for their efforts," said IAMERS founder Dave Band, of Advanced Imaging Systems.
ECRI Institute, the American College of Clinical Engineers (ACCE) and other industry observers have noted that, to date, there has been no evidence of systemic servicing issues. Steve Grimes on behalf of ACCE expressed his support for a new quality management system (QMS) standard for service providers. “While we see no evidence of a widespread safety issue to date, ACCE does recognize that service providers could benefit from a QMS standard that will help us ensure a continued high quality of service as we deal with increasingly complex and interconnected medical technology systems.”
IAMERS has been continuing its own efforts to improve independent servicer "best practices".
Last week's meeting
On August 8, Nationwide Imaging Services Inc. hosted a special IAMERS forum on quality management systems. Attending the forum were representatives of AAMI, ACCE, ECRI Institute, AMDSO and the FDA. The FDA attendees included the Director of the Office of Compliance for the Center for Devices and Radiological Health, Robin W. Newman, Consumer Safety Officer Katelyn R. Bittleman, and Electronics Engineer and Scientific Lead Reviewer James Walker. Also attending were several leading servicers including Tim Martin, president of Radon Medical Imaging; Jim Goldner, president of First Source; Hiren Desai, IAMERS ethics chairman; Dave Francoeur, senior director of Brand & Quality for Sodexo; Julie Mardikian, senior compliance auditor for Oxford Instruments Healthcare; and Jimmy Kallam, president of East Coast Medical Systems.