FDA Deadline: Service Regulation Report Due Soon

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In Congressional testimony before the House Committee of Energy and Commerce last May, Joseph Robinson, senior vice president of health systems solutions at Philips Healthcare and vice-chair of the board of directors at the Medical Imaging & Technology Alliance (MITA), stumped for a new law that would hold independent service organizations (ISOs) to the same FDA standards for medical device repair as original equipment manufacturers (OEMs).

The bill in question is “HR-2118: The Medical Device Servicing Safety and Accountability Act,” which Robinson testified “takes an important first step toward the accomplishment of this [patient safety] goal by requiring that all ISOs step out of the dark and register with the FDA, file adverse event reports, and maintain a complaint handling system.”

“Service activities performed by an independent, third-party service organization do not have the same oversight or quality, safety and regulatory requirements [as those performed by an OEM],” Robinson said. “Third parties are not even required to register with the FDA … creating an enormous blind spot.”

“These are minimum requirements which would give the agency information on how many businesses are engaging in servicing medical equipment and, we hope, will help get a better handle on adverse events to ensure that they never happen again,” he said.

Robinson went on to allege that, “unfortunately, unregulated third parties have caused a number of patient safety issues in their attempts to repair medical devices,” a familiar refrain among OEMs lobbying for the passage of the bill.

In follow-up testimony, Robert Kerwin, general counsel for the International Association of Medical Equipment Resellers and Servicers (IAMERS), told the body that HR-2118 “is a solution for which there has been no evidence of a problem.”

“If this was such a significant problem, why have we not heard the hospitals clamoring for this?” Kerwin said.

Kerwin continued by noting that OEMs and ISOs already collaborate on multivendor service agreements, that ISOs comprise many professionals who built their careers at OEMs, and that there’s a difference in scale when some of the largest companies in the world are asked to absorb policy changes that the smallest cannot.

“With the extra paperwork comes significant cost to be shouldered,” Kerwin said. “The complaint management system, the staffing, the training, the assessment costs, the outside auditors … This section basically requires every repair that’s done to be catalogued, documented and processed. In an era of smart regulation, this seems to be at odds.”
seems to be at odds.”

It’s a conflict that has emerged in an ever-consolidating health care industry, where hospital margins are razor-thin and the largest players in the business drive closer to vertical integration through channel partnerships, mergers and acquisitions, and recapturing business in secondary markets. But if there’s a patient safety problem, and not a regulatory policy one, it isn’t playing out like that in the marketplace. And as outlined in the FDA Reauthorization Act of 2017 a Congressionally mandated report will be posted on the FDA website in May 2018 regarding the continued quality, safety, and effectiveness of devices with respect to servicing. (See more at 1technation.com/fda-2017-update.)

One of the only people to analyze the FDA data on instances of device safety is Mark Bruley, vice-president emeritus of accident and forensic investigation for the ECRI Institute.

About 20 years ago, Bruley led a team from ECRI that reviewed the FDA MAUDE (Manufacturer and User Facility Device Experience) database, which hosts medical device reports submitted to the agency by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters (health care professionals, patients and consumers).

In 1996, they found that 0.2 percent, or some 240 adverse events out of about 900,000 clinical equipment reports, could have been attributable to servicing or manufacturing concerns, Bruley said. In 2016, the group updated its search of the database – which in the time since had climbed to 4 million reports, some 2.4 million of which involve the servicing of capital equipment – and found that the adverse event rate had fallen by two orders of magnitude, to 0.005 percent.

“If there’s any inkling in that report that the accident was due to ineffective repair, calibration, or servicing, don’t you think the manufacturer would jump right on there and comment to that effect?” Bruley said. “I think there’s every incentive for a manufacturer to comment on whether a servicing problem was the cause of an adverse event. I said, ‘Do your analysis. Let’s see your data.’ Here we are 18 months later, and I’ve seen nothing.”

“No one has done any evidence-based analysis of whether there are any problems or not except me and my colleagues,” Bruley said. “The only thing anyone else gave were anecdotes. Anecdotes are not data. Sometimes the legislation is based not on data, but anecdotes.”

Bruley said that ECRI published its data in June 2016 comments to the FDA along with its search methodologies; the group concluded that there wasn’t any statistically significant correlation among adverse effects and improper servicing.

“Manufacturers who wish to make more money doing their own service are pushing it as a cause celebre absent any evidence that it’s an issue,” Bruley said. “I challenged anyone when I gave testimony in October 2016 – where is your evidence that there is a problem? There are anecdotes. Where is your data from a cogent analysis? They never challenged my data. To date, no one has done the research.”

To Jim Spearman, president of Consensys Imaging, understanding the problem of regulation means recognizing the factionalism that drives most of the arguments.

“No one’s got a clear conscience and clean hands,” Spearman said. “All these different factions have an axe to grind and a cross to bear, and they say the data doesn’t show they have to be regulated. The point is we should all have this discussion.”

Spearman finds faulty the logic that FDA regulations on service and repair currently obligate medical device manufacturers to warranty their equipment until no longer in patient use. He believes that as medical devices are regulated equipment, their servicers – OEM, third-party or otherwise – must prove objectively that they are maintaining the equipment to a standard.

“What are you doing to ensure that they are being maintained to their regulatory compliant status?” Spearman said. “You should have no problem with any independent body coming in and checking them. All OEMs are mandated by the FDA to keep those records. If a third-party provider is servicing a piece of equipment, they are largely unaccountable to the FDA until an adverse event happens.”

“We come back to this fundamental question of why are we skirting the regulations?” Spearman said. “Doctors are regulated and so are airline pilots.”

Spearman also objected to the argument that regulatory processes need necessarily be financially onerous and complicated in order to be effective. Consensys has held to the ISO 13485 standard since 2010, with annual audits and a three-year recertification process. The 2016 version of the same standard includes mandatory regulatory reporting; thanks to it, “We have objective evidence that we’re regulatory-compliant,” Spearman said.

But even in instances where third-party servicers would be motivated to report their findings to the agency, sometimes it’s not in their best interests to do so, he noted.

“We took over a site in Texas, and there were 30 to 40 ultrasound trans-vaginal probes that had been illegally modified by a previous servicer,” Spearman said. “We locked them down and said they were not fit for service. I asked, ‘Do I have to notify the OEM, and do I have to notify the FDA?’”

Perhaps counter-intuitively, the answer from Spearman’s legal counsel was to not voluntarily report, so as to avoid potential liability for a problem his business did not create. He was instead advised to allow his attorneys to report it to the agencies involved to maintain his privilege of anonymity. If even such relatively benign events are at all commonplace, Spearman doesn’t hold out much hope for a regulatory solution that moves toward a higher standard of equipment and patient safety without encumbering one or more of the parties involved.

“The FDA knows this is the third rail on a subway, and they’re going to get zapped if they touch this thing,” he said. “It comes down to lobby money and funding. If you [aggravate] Congress, what are your chances of getting funding?”

Spearman also noted the break in the logic of FDA only looking to enforce the standards of service and maintenance in limited instances.

“You’re going to look the other way when the warranty expires, until a patient gets injured, and then you’re going to lock the thing down when you investigate because it’s a regulated medical device?” Spearman said. “You have regulations in law, but you are intentionally not looking to enforce them?”

More than likely, Spearman believes the FDA will pass on issuing any new enforcement of medical device repair and allow Congressional attitudes to shape the future of the law. He thinks that unless the agency sees an overwhelming amount of data that there is a legitimate health crisis related to the improper servicing of medical devices, it won’t move to regulate servicing any more than it has. Pressed to guess where the agency might lean, the 2016 ISO 13485 standard is a fitting benchmark (and one that an FDA spokesperson cited at the March 2018 International Conference on Medical Device Standards and Regulations), Spearman said. Absent any other regulatory moves, he believes the agency is likely to direct ISOs and OEMs to work together more closely for access to service manuals, training and preventive maintenance tools.

Yet Spearman noted, “we have more fundamental disconnects to this issue,” including the enforcement of existing statutes, which he pointed out is scattershot at best.

“I don’t know what to anticipate because half the stuff they say they’re going to do never happens,” agreed Sarah Lee, COO of Medical Imaging Technologies Inc. (MIT). “XR-29 was two years ago, and none of my customers are actually getting money taken away from reimbursement. We just wait to see if it’s going to happen.”

The difficulty of distinction between enforcement and compliance isn’t something that only affects regulators; rather, there’s a pass-through effect that organizations operating in the health care space feel as they await word from on high that something is changing.

“I don’t think it’s a bad thing to have ISOs have to report problems,” Lee said, citing the existence of “one-man fly-by-nights” that ISOs and OEMs alike criticize as unscrupulous and dangerous in comparison with the structured operations of more established companies.

“I think it’s the big companies against us,” Lee said. “They sit on the boards to make these rules; they’re out to help themselves.”

She said she would feel less threatened by the notion of additional regulation if there hadn’t been such longstanding efforts by larger manufacturers to discredit, in broad strokes, independent vendors and their operations.

“There are third parties that are good, and others that aren’t so good,” Lee said. “At the same time, I’ve never heard of anybody getting injured patient-wise that wasn’t something a tech did. I’ve never heard of any system error or anybody in the service industry making something harmful happen.”

One antidote to instances of adverse events is training, said MIT owner Rick Player.

“We do a lot of it internally, but we send staff off to third-party schools like RSTI (Radiologic Services Training Institute) or parts providers, and sometimes the OEMs,” Player said. “All this equipment has to be inspected on a yearly basis, and if it’s not in compliance, once you get too big, they have to look at who’s doing the service.”

“As far as what’s coming out of Washington, we can’t control any of that,” he said. “There’s no teeth. It’s just irritating. Ain’t a lot you can do.”

Player said smaller operators in the medical device field haven’t been afforded the same access to legislative remedies that larger businesses with lobbying agencies have. He marks it as a battle of “anti-business sentiment” and described “having been in business for 31 years of being hated by our government.”

“If you’re a small business in this country, it’s a fight,” Player said.

If you’re a big business in this country, it seems it’s still a fight, albeit one played out on Capitol Hill.

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