Hospital repair restrictions need to be immediately removed
The adage “an ounce of prevention is worth a pound of cure” is particularly meaningful and relevant in the context of COVID-19. Fortunately, many of us are heeding the common-sense advice of public health experts by wearing masks, following physical distancing guidelines, and increasing our handwashing. Many of us are also turning to public health experts to decipher what the latest COVID-19 data means for our state and the community in which we live.
The problems associated with the lack of testing, lack of timely testing results, hospital capacity and hospital staffing concerns have been welldocumented and regularly appear in the news. However, the COVID-19 pandemic is also putting incredible stress on our 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 that equipment. However, in too many cases, manufacturers limit access to the essential tools and information these repair experts need.
Restrictions to fixing medical equipment are comparable to tactics used by Apple and John Deere to control repair marketplaces. For example, some devices require a password or service key to read diagnostic information, other manufacturers refuse to provide access to service manuals or design machines to require calibration software to activate new spare parts, but do not make that software available.
To determine how widespread repair restrictions are, and the extent to which restrictions impact work under the stress of COVID-19, the Arizona PIRG Education Fund and the U.S. PIRG Education Fund recently surveyed 222 medical repair professionals from across the country and conducted dozens of interviews. Among the most troubling finding: 91.8% of respondents reported that they have been denied access to service information for “critical equipment” such as defibrillators, ventilators, anesthesia machines, and imaging equipment.
Of the 153 survey respondents whose departments work with ventilators, 29.2% 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, manufacturers typically charge much more for repairs than if the hospitals hire a third party or train their own technicians, giving them the incentive to cite safety concerns even without data to back up such claims. In a 2018 study, the Food and Drug Administration (FDA) found that third-party repair carries no additional risk and, just like manufacturers, “provide high quality, safe, and effective servicing of medical devices.” And more costs aren’t the only price of proprietary repair – fewer options to service equipment can lead to bottlenecks, putting patients at risk.
For each of the COVID-19 problems documented by public health experts, there is a common-sense solution. In the case of fixing lifesaving medical equipment, manufacturers need to immediately remove their restrictions. If manufacturers don’t act, public officials need to step in and give hospitals the “right to repair” medical equipment to help their patients.