The Covid-19 pandemic has ensured that our healthcare system will never be the same. As with any major systemic upheaval, there are winners and losers. The people who “win” are those who have won in America for decades, including a large health care system big enough to withstand pandemic headwinds and emerge with new discoveries desire to integrate.
The “losers” are exactly what you’d expect too — including small providers serving primarily black and brown people who, in addition to providing quality care, must also confront the social determinants of community health. Small, rural and chronically underfunded suppliers have clearly been hit harder by the pandemic.One recent reports The American Hospital Association confirms what many advocates already know; these small providers are hurting financially. very bad.
With hospital admissions rising again from Covid, these similarly disadvantaged providers now face a potential surge in healthcare demand related to subvariables and the impact of long-term Covid. Hospitals caring for patients in urban and rural areas need all the support they can get to support their operations, including ensuring their medical equipment is working to its full potential.
This brings me to equipment maintenance – which you usually think is not the biggest headache for a hospital. But someone has to maintain, inspect, replace worn parts, and install updates for the various medical devices that the U.S. health care system needs to run on a daily basis.
While medical equipment repairs are often not of the utmost importance, even for hospital administrators, you might be surprised – like me – to learn that third-party equipment service providers have different quality and safety standards than the manufacturer’s technicians, though were hired to work on the same machine. Third-party service providers do not have to be registered with the FDA and do not have to comply with any quality and safety requirements set by the agency.
Oversight by service technicians has a direct impact on the safety of these medical devices and whether they work as intended by the manufacturer.For example, last year, manufacturers Alaris Infusion Pump 8100 Thousands of products were recalled after its technicians noticed dozens of incidents of cracked or detached front baffles of machines causing them to malfunction. The problem was traced to a contractor servicing the equipment with replacement parts made in China that were not FDA overseen.
As bad as this example is, it’s not an outlier.in a 2018 report, the FDA concluded that most adverse medical device events reported to the agency — including those resulting in deaths — are considered examples of poor service quality and are the result of unregulated remanufacturing activities. The line between repair and remanufacturing is blurred at best and needs clarification urgently. The FDA recently told Congress that it welcomes efforts to improve clarity on the difference between low-risk “repair” and high-risk “remanufacturing.” For hospitals, providers, and patients, clarity hasn’t come fast enough. Everyone who encounters a medical device should know if it works as intended and is FDA-approved.
A bipartisan group of lawmakers agreed to work to strengthen the FDA’s role in the medical device user fee agreement that must pass before Congress.This Clarifying Remanufacturing to Protect Patient Safety Act Presented by Representatives Scott Peters (D-CA), Kim Schrier (D-WA) and John Joyce (R-PA) to clarify what medical device remanufacturing means and empower FDA to educate company technicians so they know if they have Crossing the line into a regulated activity.
but unregulated services Shelving legislation Claims from the user fee package that, as the FDA itself welcomes, clarifying regulated FDA activities is overly broad and unnecessary. While I’m not sure why any organization that prides itself on quality would object to being clearer, I don’t think there’s any excuse for not knowing that your job has crossed the line from repairing equipment to changing how it’s performed.Imagine telling clients that you are following a strategy similar to “know nothing” Hogan’s hero Sargent Schultz? Not knowing if your team is remanufacturing hospital equipment doesn’t seem to be in the best interest of patient safety.
FDA’s long-awaited remanufacturing guidance becomes more relevant as Congress passes service accountability. To help companies understand the difference between service and remanufacturing, FDA must educate service companies on remanufacturing and enforce these requirements.
The bottom line is that patients don’t want to find out they’ve been treated with unregulated, remanufactured medical devices, and doctors don’t want to stake their professional reputation on machines that have changed their approved intent with too few resources to care for vulnerable patients. Hospitals don’t want to deal with the consequences of repaired machines not functioning properly, which could expose patients to significant safety risks. Everyone should rest easy knowing that these devices are as safe as possible.
Photo: Who am I, Getty Images
