COVID-19: Proprietary Medical Device Repair to Threaten Patients

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The COVID-19 pandemic has created unbearable stress on the medical system in the United States, alongside devices such as ventilators necessary to diagnose and treat virus-infected patients. Particularly, since these tools are utilized nonstop, biomedical repair experts are finding it challenging to keep up and fix them at a mounting speed.

Due to which certain manufacturers are limiting the access to such tools and crucial information needed by the repair experts. The latest study by the Hospital Repair Restrictions, the U.S. PIRG Education Fund, discusses the issues the medical professionals face because of the barriers set up by the device manufacturers, as well as the outlines of the steps to follow by the hospitals.

This exploration report involves a review of 222 medical fix experts and a few different interviews. It states that 91.8% of respondents report the access denial issue to service information for important devices like anesthesia machines, ventilators, imaging equipment, defibrillators, etc.

Nathan Proctor, U.S. PIRG Education Fund’s Right to Repair Campaign Director and the author of the report, says, “There is a strong financial incentive for manufacturers to restrict repair. They want to get hospitals to buy repair service contracts from the manufacturer. Manufacturers typically charge much more for repairs than if the hospitals hire a third party or train their own technicians — but more costs aren’t the only price of proprietary repair. Delays in getting equipment running put patients at risk.”

Both the U.S. PIRG and the U.S. PIRG Education Fund have asked manufacturers of crucial medical equipment such as ventilators, to collaborate with biomedical technicians and offer them the required data of parts, and other services for repairing medical devices. Likewise, in April, certain manufacturers have responded to this by offering additional service information for ventilators.

Sam Jacques, VP of Clinical Engineering at McLaren Health Care, states, “Restricted access to service materials for critical health care equipment has become a growing problem that hospitals are dealing with every day. COVID-19 has been a kind of stress test for our medical system – and unnecessary manufacturer-imposed restrictions on repair is a barrier to safe and effective care, but one of the easiest to remedy”.

“Like many other biomeds, I have faced life-or-death situations where you have to fix a piece of equipment in an hour or two, or a patient will die. Our access to service materials needs to reflect that reality — we need access on-demand,” adds Nader Hammoud, Clinical Engineering Manager of the California Association of Medical Instrumentation.

Makers express that the limitations put by them are to guarantee patient security. Nevertheless, in 2018, the Food and Drug Administration (FDA) revealed that third-party repair comes with no risk and, like manufacturers, provides safe, effective, and high-quality servicing of tools.

Proctor further says, “We need to stand up and help our hospitals right now. One easy thing we can do is to remove barriers to fixing life-saving medical equipment. It’s no time to be proprietary.”