Earlier today at an Energy and Commerce Subcommittee on Health hearing on the Medical Device User Fee Act (MDUFA IV), the chairman of the Medical Imaging & Technology Alliance (MITA) called on the U.S. Food and Drug Administration (FDA) to require consistent regulation of third-party and original equipment manufacturer (OEM) medical device servicers to ensure patient safety and proper device functionality, according to a statement on the MITA website.
Joe Robinson, chairman of the MITA board of directors and senior vice president of health systems solutions at Philips Healthcare, said that medical imaging device manufacturers have discovered tin foil, sheet metal screws, non-labeled wiring, hand-secured wire nuts, zip ties and tape used by third-party service companies in attempts to repair imaging equipment such as CT, MRI, and ultrasound, according to the MITA statement.
Robinson said the medical imaging industry strongly supports H.R. 2118, “Medical Device Servicing Safety and Accountability Act,” introduced by Reps. Ryan Costello (R-PA) and Scott Peters (D-CA) earlier this week, according to MITA.
The bipartisan bill adds regulation for the servicing of medical devices by requiring third-party servicers to register with the FDA, submit adverse event reports, and hold themselves accountable by maintaining a complaint handling system.
“Many third-party servicers do operate safely and effectively, as do the devices they service. But by not operating under the same FDA regulatory structure as OEMs, third-party servicers are forcing patients to take a leap of faith about the upkeep of the device. That’s a risk patients shouldn’t have to take,” Robinson said according to the MITA report.
According to MITA, Robinson also called Costello and Peters’ bill a “reasonable and common-sense solution that will protect patients who rely on the safety, effectiveness and reliability of our technologies and not be costly or burdensome to third-party servicers.”
However, not everyone supports the proposed legislation.
Robert J. Kerwin, General Counsel, International Association of Medical Equipment Remarketers and Servicers Inc. (IAMERS) also testified before the committee today. His testimony reflects a common belief among many in the healthcare technology management industry.
A summary of Kerwin’s testimony, as posted on the Energy and Commerce Committee website, makes a case against the proposed legislation.
“This Legislation is a solution for which there has been no evidence to support there is a problem,” according to the posted summary of Kerwin’s remarks. “The respected scientific research institute, ECRI Institute, after reviewing the FDA MAUDE reports, submitted to the FDA in March 2016 a report (110 pages) which concluded that there is no evidence to date that a patient safety problem exists. The American College of Clinical Engineering also stated that there is no real-world evidence to support further regulation. This legislation will require independent servicers to absorb the cost of complying with the Quality System Regulations as if the servicers were manufacturers or pass these costs along. This Legislation will hurt rural and regional healthcare. Rural and regional hospitals rely heavily on independent servicers for competition and lower prices and if the independent servicer is not available, this greatly impacts the rural hospitals. Some servicers will not be able to compete.”
In his testimony Kerwin relied on facts and data collected by the FDA.
“In March 2016, the FDA opened a public docket to solicit comment on (among other things) whether to regulate servicers. The FDA received comments from 177 interested parties. It is interesting to note that there was almost a complete absence of negative comments from hospitals and group medical practices with respect to independent service organizations,” Kerwin states. “It is perhaps worth repeating then … if this legislation is truly addressing a serious health care issue, why is there no clamor from the hospitals to impose a change? Respectfully we urge the Committee not simply to accept the statement of IAMERS but look at the comments submitted on the FDA Public Docket by independent industry observers. The nationally recognized leader in performance measurement, the Joint Commission, in its comment filed in the FDA docket, stated that the Joint Commission ‘has no knowledge of any statistically significant level of safety problems resulting from the activities of any kind of maintenance/service provider.’ In its comment, Penn State Health stated ‘[v]ery little evidence of systemic problems exists.’ Citing four statistical analyses which reviewed the root cause of events, Penn State further stated the ‘analyses above clearly show that inappropriate servicing and maintenance is not a statistically significant root cause for safety events.’ ”
“In October 2016, the FDA held a two-day workshop on October 27-28, 2016 entitled the ‘Public Workshop-Refurbishing, Remarketing, Remanufacturing and Servicing of Medical Devices Performed by Third Party Entities and Original Equipment Manufacturers.’ Over 500 people attended in person and many more attended via web access,’ Kerwin adds. “Over 40 speakers presented and 20 additional attendees voiced their opinions. MITA showed pictures of equipment issues, attributed to nameless independents and advocated for further regulation. The American College of Clinical Engineering offered that there was a lack of real world evidence to support MITA’s advocacy for additional regulation. IAMERS advocated that the FDA should not regulate by anecdote. The FDA has advised that it is preparing a summary of the information gathered at the workshop. In the last few months, the FDA has contacted stakeholders to clarify and confirm stakeholder information and identify takeaways from the workshop. The FDA report has not, yet, issued.”
For more information about the issue, visit the Energy and Commerce Committee website.
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