In the past 18 months, the Covid-19 pandemic has certainly put tremendous pressure on the country’s healthcare system. Hospitals are overcrowded, doctors are overwhelmed, and supplies are often insufficient. Providers have been trying to ensure the safety of patients by taking additional measures to purify the air, disinfect equipment and maintain social distancing. However, one aspect of hospital preparations may undermine safety precautions: personnel who repair and repair ventilators, CT machines, infusion pumps, and many other life-saving medical equipment are unqualified.
Medical equipment, including imaging scanners that use super-strong magnets or radiation, all run using highly sophisticated software. If this equipment is not properly maintained, malfunctions may lead to serious consequences. Many patients and even operating technicians believe that the equipment should only be maintained and repaired by well-trained and supervised technicians who must comply with legal provisions. Unfortunately, this is not the case.
Although device manufacturers are required to comply with U.S. Food and Drug Administration (FDA) regulations to maintain and service these complex medical devices, independent service operators (ISO) are not subject to these strict standards. This means that ISO or third-party service providers do not need to take the same checks and balances to ensure that their repair work is completed smoothly, so as to ensure that the equipment is as safe and effective as the FDA approved continued use. First of all, the market.
It is illogical to supervise the manufacturer’s service provider rather than an independent service company, and it leaves a huge loophole in the supervision Put patients at greater risk From electric shocks to burns to overexposure to radiation to medical errors in improper doses. Follow the illogical argument of ISO to conclude: If third-party service providers do not need supervision, why should FDA care about any service providers?
Independent service personnel claim that their work is completely safe and does not need to be supervised.In order to consolidate their position, they point to a 2018 FDA report In terms of service, it is said that “third-party entities continue to provide services and repair medical equipment are essential to the operation of the US healthcare system.”
No one thinks that third-party services are not important. This is. Viable third-party services will increase market competition, thereby reducing prices. In addition, even OEMs occasionally provide third-party services on other companies’ equipment, which increases competition and choice for hospital customers. Third-party services are important, which is why all service providers should follow the same FDA regulatory quality management process that the manufacturer has already implemented.
FDA’s Recent guidance Remanufactured medical devices may mark progress. In its initial report in 2018, the FDA found that most of the reported adverse events, including patient deaths, can be attributed to “remanufacturing,” which means that the service exceeded its intended purpose. Remanufacturing can change the function of the device, which means that it no longer operates in an authorized manner—increasing the risk for the patient. I hope this guide will provide the FDA with tools to let service personnel understand the difference between remanufacturing and repairing medical equipment. But to do this, the FDA still needs a mechanism to contact companies whose activities may cross the remanufacturing line. This is another argument for regulating third-party service providers. How does the FDA educate companies that they don’t even know exist? They can’t. This is why these service providers should be required to register with the FDA.
Emphasizing the need for federal regulation is that independent service providers claim that they have the right to “repair” medical equipment, and that state legislatures, including California, should force equipment manufacturers to hand over their service manuals, passwords, and other proprietary documents. Such a proposal will make it easier for unsupervised and irresponsible service providers to get under the hood of devices, such as CT scanners, and expose vulnerabilities, including device failures and even cyber hackers.
Therefore, independent service operators not only scoff at the need to comply with FDA standards, but they also hope that the legislature will force their competitors to hand over intellectual property rights to irresponsible actors, and in the process disclose their expertise to anyone with an Internet connection. There is information. Without proper accountability, the risk for patients increases because it is not clear how to use or access the collected data.
“Right to repair” advocates urge California and national policy makers to authorize these third-party ISOs, and Congress must act nationwide to ensure that all patients can rest assured that all medical equipment is safely and effectively repaired. By strengthening the supervision and supervision of ISO to ensure the quality, safety and effectiveness of all equipment services; implementing the enforcement mechanism of remanufacturing regulations; and educating ISO on new remanufacturing guidelines, Congress and the FDA can prevent future Patients and providers have to experience unnecessary injuries caused by incorrect maintenance of medical equipment.
I urge Congress to follow the science and force the FDA to ensure that all complex medical device services are properly regulated.
Photo: Justin Sullivan, Getty Images
