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Proprietary medical device repair harms hospitals, could threaten patients, during COVID-19 pandemic
PHILADELPHIA -- The coronavirus (COVID-19) pandemic is putting incredible stress on the U.S. medical system, including the equipment that is essential to diagnose and treat patients, such as ventilators. As that equipment is pressed into round-the-clock use, biomedical repair technicians face increasing pressure to maintain and repair all that equipment. However, in too many cases, manufacturers limit access to the essential tools and information these repair experts need. A new report by the PennPIRG Education Fund, Hospital Repair Restrictions, details the challenges that medical professionals face as a result of device manufacturers setting up barriers to repair, and outlines steps to take to help hospitals.
The report includes a survey of 222 medical repair professionals, as well as dozens of interviews. Among the most troubling findings is how common restricted repair is -- with 91.8 percent of respondents reporting that they have been denied access to service information for “critical equipment (defibrillators, ventilators, anesthesia machines, imaging equipment, etc.).”
“There is a strong financial incentive for manufacturers to restrict repair. They want to get hospitals to buy repair service contracts from the manufacturer,” said Emma Horst-Martz, PennPIRG Education Fund Campaign Associate. “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.”
“Hospitals need to be able to fix their own life saving equipment in a global pandemic,” said Pennsylvania State Treasurer Joe Torsella. “Every day, healthcare workers put their lives on the line caring for critically-ill COVID-19 patients, and we must remove this needless barrier that manufacturers have placed on them. Our entire global community has made sacrifices to help fight the spread of this virus. It’s far past time for manufacturers to do their part to fight for as many lives as possible, by making this repair information available.”
“My Right to Repair bill at first was an initiative to help consumers fix everyday items, but COVID-19 has completely changed the path and significance of this legislation. As we’ve already seen, hospitals’ inability to fix ventilators in-house is rendering a large percent of these much-needed devices unusable,” Representative Austin Davis (D-McKeesport) said. Davis is the primary sponsor of HB2326, the Digital Fair Repair Act. “Right now we need to ensure all hands are on deck in the fight against the COVID-19, and my legislation, will ensure that hospitals have the devices they need to save lives.”
Since March, PennPIRG and PennPIRG Education Fund have called for manufacturers of medical devices, especially ventilators, to cooperate with biomedical technicians and provide the information, parts, and other service information needed to repair critical medical equipment. In April, a number of manufacturers responded to public outcry by releasing additional service information for ventilators.
Of the 153 survey respondents whose departments work with ventilators, 29.2 percent report that they currently (as of June 12, 2020) have ventilators that they cannot use because they lack access to parts and service information.
Manufacturers claim that these restrictions are in place to ensure patient safety. However, the Food and Drug Administration (FDA), in a 2018 study, found that third-party repair carries no additional risk and, just like manufacturers, “provide high quality, safe, and effective servicing of medical devices.”
“Now time is of the essence when a patient with the coronavirus needs to be put on a ventilator,” said Representative James Roebuck. “There is not time to send the machinery back to the manufacturer or wait for the manufacturer to decide to repair the vital equipment. Imagine if you are in a rural area and you just must fix the ventilator to save a life. Legislation by Rep. Davis would force the ventilator manufacturers to allow hospitals and medical centers to use their own trusted employees to make repairs in a short period of time - if only the ventilator manufacturers would share the equipment and tools necessary to do this. We know that the public has enough to worry about with the surging number of cases being diagnosed, but we urge everyone to support this legislation so we make strides together.”
“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,” added Horst-Martz.
A copy of the report to download is available here.
The recording of the zoom video. The webinar begins at minute 02:25.
The presentation slides for additional visuals.
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