For Hospitals and Patients, We Need New Medical Device ‘Right to Repair’ Laws

When COVID-19 infections overwhelmed New York City in March 2020, one of the city’s largest health systems lacked space to store badly-needed new medical equipment. Instead, the new equipment was delivered and stored at two Crothall Healthcare warehouses in Melville, N.Y., where our team of biomedical technicians and clinical engineers tested more than 5,000 pieces of medical equipment that was used to help keep patients alive.

The equipment included thousands of ventilators inspected by trained Crothall personnel who specialize in respiratory equipment. Their expertise proved critical since, in many cases, the equipment’s original equipment manufacturers didn’t have enough personnel available to perform testing.

With the omicron variant resulting in increased hospitalized patients nationwide, we hope there won’t be a repeat of this scenario. But this one example demonstrates how trained technicians and clinical engineers working for independent service organizations (ISOs) are qualified to service medical equipment.

Unfortunately, many manufacturers don’t allow ISOs to repair their equipment – an anticompetitive practice that hinders patient safety and drives up costs for hospitals. The latter issue affects all health systems, but particularly small-town and rural hospitals, many that are fighting to stay open. Delays of several hours or days may occur when the equipment fails -- despite the availability of qualified biomedical technicians on site.

To change that situation, Crothall and other independent companies that make up the Alliance for Quality Medical Device Servicing are fighting for new laws. And there is mounting evidence that change is needed:

  • A 2018 study by nonprofit ECRI Institute found that of 2.1 million device failure reportssubmitted to the Federal Drug Administration over the past 10 years, only 0.005 percent of failures could be attributed to service or maintenance issues.
  • A 2018 report by the Federal Drug Administration found that third party repair carries no additional risk and that both they and manufacturers “provide high quality, safe, and effective servicing of medical devices.”
  • A December 2020 survey of 222 medical repair professionals by the US Public Interest Research Group found that 64% report that are denied access to service information or critical equipment either “most of the time” or “somewhat frequently.”

There is movement among many federal and state lawmakers to allow ISOs to repair medical devices. The Critical Medical Infrastructure Right-to-Repair Act of 2020, introduced in Congress, is designed to remove barriers to fixing medical equipment during the COVID-19 pandemic imposed by manufacturers. While this bill did not move forward, a General Accounting Organization (GAO) study is underway and may lead to a reintroduction of the bill.  

The GAO study was requested by Senate Finance Chairman Ron Wyden (D-OR) and included input from the Alliance for Quality Medical Device Servicing.  The results from the study are due this year and should help shape future Right to Repair legislation.  Additional congressional activity in the House of Representatives around right to repair is expected in 2022. 

Of course, even with new laws, hospitals should still have the right to choose how their medical equipment is repaired. So, how do we know ISOs have the skilled biomedical technicians and clinical engineers to repair life-saving equipment?

We feel the case is crystal clear. Today, independent medical service providers employ tens of thousands of employees across all 50 states and service millions of medical devices. Crothall alone has more than 600 imaging engineers, biomedical equipment technicians and managers who maintain more than one million pieces of medical equipment at more than 175 hospitals. And, during the height of the pandemic, some OEMs allowed us to repair their equipment – even more evidence of our capabilities.

All of our personnel have the requisite education and technical experience; they must also pass an annual competency evaluation to ensure they are qualified to service and maintain all medical equipment. Like other ISOs, we also invest in continuous training. Crothall pays for every associate pursuing industry and biomedical certifications and we facilitate study groups to promote success. And, despite our differences with OEMs over the right to repair issue, we have strategic partnerships with them and other vendors to provide customized training courses.

We realize that manufacturers have invested millions of dollars to develop and produce highly efficient equipment for our nation’s healthcare systems.

However, current restrictions, such as use of service manuals and other critical information may limit the transfer of knowledge, thus creating risk. We believe this can be done without disclosing proprietary technologies while making it easier and faster to repair critical medical equipment.

Together, we and the manufacturers have a singular focus:  providing safe medical devices for the best patient care. Giving us the right to repair all medical devices and equipment will help achieve that goal.

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