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Clarity will help stem the problem of ‘winners and losers’ in medical device safety and security – MedCity News

Clarity will help stem the problem of ‘winners and losers’ in medical device safety and security – MedCity News

The Covid-19 pandemic ensured that our healthcare system will never be the same. And like any major system upheaval, there were winners and losers. Folks who “won” are exactly those who have been winning for decades in America, including the large healthcare systems that were big enough to weather the pandemic headwinds and emerge with a newfound appetite for consolidation.

And the “losers” are also exactly who you’d expect – including small providers serving predominately Black and Brown populations, who must confront social determinants of health in their communities in addition to delivering quality care. Small, rural and chronically under-funded providers have clearly been hit extra hard by the pandemic. A recent report from the American Hospital Association confirms what many advocates already knew; these small providers are economically hurting. Badly.

With hospitalizations once again rising from Covid, these same disadvantaged providers now face a potential surge in demand for medical care related to the effects of subvariants and long Covid. Hospitals caring for patients in urban and rural settings need all the support they can get to support their operations, including ensuring their medical equipment is performing to the best of its potential.

Which brings me to equipment maintenance – not something you would normally think would be a major headache for hospitals. But someone must maintain, inspect, replace worn parts, and install updates on the variety of medical equipmentnecessary for the everyday running of America’s healthcare system.

While medical device repair isn’t usually top of mind, even for hospital executives, you may be surprised – as I was – to learnthat third-party device servicer vendors aren’t held to the same quality and safety standards as the manufacturers’ technicians despite being hired to work on the same machines. Third party servicers don’t have to register with the FDA, nor do they have to follow any quality and safety requirements set by the agency.

The oversight of a service technician has a direct impact on the safety of these medical devices and whether they perform as the manufacturer intended them to work. For example, last year, the manufacturer of the Alaris Infusion Pump 8100 recalled several thousands of its products after its technicians noticed dozens of incidents where the front bezel on the machine was cracked or separated, which caused them to malfunction. The problem was traced back to contractors that serviced the devices using replacement parts manufactured in China that had not undergone FDA oversight.

While this example is terrible, it’s not an outlier. In a 2018 report, the FDA concluded that most adverse medical device events reported to the Agency – including those contributing to deaths – that were thought to be examples of poor service, were the result of unregulated remanufacturing activities. The line between servicing and remanufacturing is blurry at best and in dire need of clarification. The FDA has recently told Congress it welcomes work to improve clarity around the difference between low risk “servicing” and high-risk “remanufacturing.” Clarity can’t come soon enough for hospitals, providers and patients. Everyone who encounters a medical device deserves to know if it is working as intended and as approved by the FDA.

A bipartisan group of lawmakers agree worked to strengthen the FDA’s hand in the must-pass Medical Device User Fee Agreement now before Congress. The Clarifying Remanufacturing to Protect Patient Safety Act was introduced by Reps. Scott Peters (D-CA), Kim Schrier (D-WA), and John Joyce (R- PA) to clarify the meaning of medical device remanufacturing and empower the FDA to educate company technicians so they know if they’ve crossed the line into a regulated activity.

But the unregulated service industry stalled the legislation from the user fee package claiming that clarifying a regulated FDA activity, as the FDA itself welcomes, is too broad and not needed. While I’m not sure why any organization that prides itself on quality would oppose more clarity, I don’t believe there is any excuse for not knowing your work has crossed the line from repairing a device to changing how to performs. Imagine telling a customer you’re following a “know-nothing” strategy similar to Hogan’s Heroes’ Sargent Shultz?  Not wanting to know if your team is remanufacturing hospital equipmentdoesn’t seem to be in the best interests of patient safety.

With Congress taking a pass on servicing accountability, the FDA’s long-awaited guidance on remanufacturing becomes even more pertinent. To help companies know the difference between service and remanufacturing, the FDA must educate servicing companies about what constitutes remanufacturing and to enforce those requirements.

The bottom line is that patients don’t want to find out they’ve been treated with a medical device which has been subject to unregulated remanufacturing, physicians don’t want to stake their professional reputation on a machine that’s been changed from its approved intent, and hospitals with too few resources to care for vulnerable patients don’t want to deal with the fallout from a repaired machine that doesn’t perform as it should, and which could expose patients to major safety risks. Everyone deserves to have the peace of mind of knowing that these devices are as safe as can be.

Photo: Who_I_am, Getty Images