About a year after considering Congressional testimony from a variety of medical device servicing and manufacturing groups, the U.S. Food and Drug Administration (FDA) in May issued a long-awaited guidance document on “the quality, safety and effectiveness of servicing of medical devices” (FDARA 710).
The 28-page report qualified a number of concerns in the medical device space from the agency’s perspective, including a handful of key points that could establish future ground rules for the interaction among original equipment manufacturers (OEMs) and third-party independent service organizations (ISOs).
In short, the agency’s key conclusions:
As a result of those findings, FDA said it will pursue the following:
Although the FDA report reads like a vindication of the long-held position of third-party parts, sales and service providers that their work is valuable to the U.S. health care system, many of those working in the field aren’t crowing in its wake.
“I don’t think we were looking for a victory,” said Rick Staab, CEO of The InterMed Group of Alachua, Florida. “What we did do is substantiate that there is not anything indicating that there’s a problem with third-party service organizations. FDA responded and said, ‘These independent service groups are clearly a need for our health care system.’ ”
“They just realized what we were saying,” Staab said. “FDA could have been plain vanilla and said, ‘We’re going to continue to investigate.’ They came back with a very strong stance, which is good.”
Staab said that the FDA document doesn’t change dramatically the landscape of the medical equipment industry, but rather confirms the need for OEM and ISO business groups to come together around discussions of what data ought to be tracked. Top on its priority list is the challenge of mitigating or eliminating risks to patient safety, but responding to that challenge involves cultivating a multiplicity of perspectives from various types of players in the field. It also involves curating objective and universal standards for device maintenance, and sharing methodologies for doing so across the industry.
“I think when we dig, what we should do as an industry is work together, both OEM and independents, to come up with the information that we can analyze to say, ‘We need to make changes [to our operating procedures],’ ” Staab said. “Even if you make changes, how do you know that they’re successful if you don’t know what you’re tracking? What we have to do before we make further regulation is to determine where we’re getting the information from to make these decisions. What do the numbers tell us? Are we better or worse at this?”
Staab believes that more clearly defined standards will also go a long way toward alleviating categorical criticisms leveled at non-OEM vendors. A popular narrative among critics of the ISO industry is that companies that don’t build medical devices don’t know how to service and maintain them, or that allowing ISOs to do so would be dangerous. Instead, Staab thinks greater definition of and access to OEM specifications can help the industry reach a higher ground on the whole.
“You can better our industry, or make sure that people are aware of what’s required in our industry, if you address what’s loose right now,” he said. “Overall, the entire industry is concerned with the anomalies – the people that are out there changing the intended function of the device because it’s cheaper for them to do. Everybody knows that’s not right. You just have to figure out how are we going to capture that. You shouldn’t make regulations that only addresses one percent of the population.”
Staab said he is in favor of greater cross-disciplinary collaboration within the medical device industry, the better to press for standards-based repair guidance. Consistency in the handling of different classes of devices is one way to get there, and he said that ISOs have long requested greater access to device manuals and clearer definition of repair schedules in order to accelerate the pace and quality of device maintenance. OEMs typically deem such information proprietary and thus not fit to be shared on the grounds of preserving competition. But the existence of standards can only help open the door for improved device performance, uptime and overall safety. And if FDA wants the adoption of quality management principles by equipment servicers, a foundational precept of any quality system is having a standard to which to adhere.
“Maybe some of the 510K processes will help the independents in the long run,” Staab said. “We have to follow the manufacturer’s preventive maintenance (PM) procedure, but there’s some where I can look at a manual on a device, and it will have certain procedures, and there will be another model, and it will have a change in procedure. How will you know that you’re following the right one? There’s no list, and I see manufacturers that don’t know which PM procedure to follow.”
“It’s the same thing as with cybersecurity,” he said. “We don’t know a lot of times about the vulnerabilities unless you have put the things in place to identify the most updated software package. To me, the manufacturer has an obligation if they’re driving the fact that we have to follow their procedures: ‘Here is the list of the procedures that you’re supposed to do.’ Otherwise, who’s going to check that? How are you going to police it?”
Staab believes that the industry-wide collaborative communities that FDA notes as a strategic priority for the medical device space also can help gather metrics to drive other of its objectives in FDARA 710, including defining servicing in the context of remanufacturing, reconditioning, and reselling; collecting data on device failures and their frequency rates; and improving cybersecurity practices. Those gains only come when a variety of industry groups like the Association for the Advancement of Medical Instrumentation (AAMI), Medical Imaging & Technology Alliance (MITA), International Association of Medical Equipment Resellers and Servicers (IAMERS), and the like sit down together and identify shared goals and pathways to achieve them.
“I don’t think it’s going to change the landscape at all until we come up with a committee that helps or further defines the things that we may know or want to accomplish,” Staab said. “I think what you need is some body that can be transparent and open, and share the information. You’ve got to get people at the table that aren’t defensive. It’s there to build a better industry for the future, and it’s not something that should be used against you. I think you double the amount of time or quadruple the amount of time to do what it takes to do [when you silo].”
Attorney Robert Kerwin, general counsel for IAMERS said he is hopeful that the FDA report will represent an opportunity for greater collaboration.
“The FDA’s report was thoughtful and deliberative, and we intend to continue to work on these issues,” Kerwin said. “By no means are we treating this as the end. We’re continuing to improve our processes. We hope in the future that we’re going to be addressing further questions of independent servicer access to service keys, manuals and training.”
Kerwin said organizations like IAMERS and AAMI can help shape the conversations around important issues such as remanufacturing versus maintenance and servicing. Even though ISOs may constitute less than 10 percent of that industry, their contributions to the health care ecosystem are, as the FDA noted, essential.
“We think further collaboration makes good sense,” Kerwin said. “We think all issues in the formation and implementation of standards need to be on the table including: service codes, passwords, access. If you want to calibrate equipment to a certain level but you’re not providing access to the service keys, etc., then we may have situations where we can’t fully meet the requirements. If it truly is about patient safety, why should this information be withheld?”
“Many of our ISOs are alumni of manufacturers, and we see many successful multi-vendor relationships with manufacturers where the ISOs are working hand in hand with them,” he said. “The practical reality is that they’ve very successfully worked over the years. We think there are good, solid, economic concerns in addition to patient safety reasons for cooperation in this area, and we hope that the FDA report and its recognition of third-party servicers as necessary for the health care ecosystem, will bring about greater cooperation.”
Medical device forensic investigator and author Mark E. Bruley, vice-president emeritus of the ECRI Institute of Plymouth Meeting, Pennsylvania, has combed the FDA Manufacture and User Facility Device Experience (MAUDE) database twice in the past 20 years to study the occurrence of adverse patient safety events related to the servicing of medical devices. From the MAUDE data, which includes 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), Bruley couldn’t find any evidence that third-party servicers were significantly adversely affecting patient outcomes.
Out of about 900,000 clinical equipment reports, they found that just 0.2 percent, or some 240 adverse events, could have been attributable to servicing or manufacturing concerns, Bruley said. In 2016, the group led an updated 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 same adverse event rate had fallen by two orders of magnitude, to 0.005 percent.
In FDARA710, the agency noted that “comments, complaints, and adverse event reports alleging that inadequate ‘servicing’ caused or contributed to clinical adverse events and deaths actually pertain to ‘remanufacturing’ and not ‘servicing,’ ” a note that Bruley described as “incredibly on-point and true as it relates to maintaining quality within U.S. health care.”
“The collateral good that will come out of this will be the more focused attention on quality assurance for anybody that does medical device repair; more focused attention on putting quality measures for good, quality servicing,” he said. “I’m glad FDA came to basically the same conclusion as it did in 1998 when I was presenting the data – but don’t ask me in another 20 years to come back and do the same thing.”
Bruley said that he is disappointed that no contrary or additional analysis based on that data has been presented; in testimony before the House Committee of Energy and Commerce last May, groups like MITA criticized ISOs for failing to take more concrete steps toward creating the adverse event reports and complaint handling systems that OEMs must maintain. But none of them had any data to substantiate their criticisms beyond a handful of anecdotal instances. Bruley believes that if they want to get to the bottom of the patient safety issues at work in the field, manufacturers should publish the data in their own repair records.
“In two years, nobody has done that other than ECRI,” Bruley said. “Our data went basically unchallenged except for the ‘yeah-but’ arguments that people make, which is, ‘Yeah, but there’s underreporting [of adverse events] and everybody knows it.’ If a manufacturer has any inkling that an injury or death was due to faulty repair of a third party, there’s every reason for them to make those comments from a self-defense medical and legal argument. So, I don’t buy into any argument that there’s under-reporting of faulty maintenance and repair.”
Nonetheless, that conclusion is merely the jumping-off point for collaboration and standards development around the quality of device service and general oversight, which Bruley believes will take years to coalesce.
“For the moment, the community can sit back and reflect on where things should effectively proceed in regard to improving self-management and oversight as opposed to regulatory management and oversight, which obviously is not needed,” he said. “Health technology managers and clinical engineers have a process for evaluating what’s wrong with a product, where to get the repair parts, and how to fix it. It’s all part of managing a clinical repair department.”
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