The argument for the right to repair has been strengthened with the onset of the pandemic.  What do onsite teams do when manufacturers won’t schedule equipment servicing or won’t provide onsite teams the tools and resources needed to repair critical medical equipment?  Binseng Wang, Vice President of Program Management for Sodexo Healthcare Technology Management, sat down (virtually) with MultiMedical Systems to discuss the challenges facing HTM teams.

The Significance of the Right to Repair: “This is a collective effort of individuals and companies who want to perform repairs on products that they own (or are owned by others) and they need resources/parts tools from the manufacturers,” said Binseng Wang 

The reality is everyone is affected by the right to repair. The pandemic made this issue clear when major manufacturers have been unwilling or unable to send their service teams to hospitals to perform repairs (due to travel restrictions or to protect employees). Thus, repairing and scheduling maintenance of critical equipment fell on the shoulders of the onsite team. Some manufacturers were cognizant of the tenuous situation, said Wang. They opened up and offered to supply equipment to us. The bottom line is: We all had to pitch in to make the equipment work reliably and safely or many more people would have died.

What prevents the right to repair from being enjoyed wholly across the United States? [Manufacturers] are reluctant to release this information, said Wang. Some manufacturers believe there is a risk to patients when service is performed by individuals who are not privy to the manufacturer's proprietary information and tools. According to Wang, this belief has devastating consequences. They're holding up progress and preventing better care for patients.

The data agrees. According to an in-depth study conducted by the FDA at the request of Congress in 2018, The current available objective evidence is not sufficient to conclude whether there is a widespread public health concern related to servicing of medical devices, including by third party servicers, that would justify imposing additional/different burdensome regulatory requirements at this time.

But to Wang, this isn't a partisan issue. We have several states right now with these types of bills introduced in state assemblies from either side of the aisle. Ultimately, supporting the right to repair is of benefit to everyone. Patient outcomes depend on the proper functioning of equipment.

There is no diagnostic service provided to a patient without some type of instrument, said Wang. There are needs all along the continuum of care from diagnosis to treatment to recovery that involve equipment that needs servicing, recalibration, and maybe even replacement of critical parts.

So, what can we do to support the right to repair? Wang outlines three recommendations:

  1. Manufacturers ought to provide service information instructions without revealing any trade secrets – and they ought to be provided at cost. (This is nothing new considering there are medical devices for which the FDA categorically sets such requirements [e.g., lasers].)
  2. If the equipment includes software, manufacturers ought to provide a code or access key to access the error codes generated by the machine. The manufacturer would still have the benefit of protecting their proprietary information and on-site teams will be able to understand and troubleshoot errors.
  3. Manufacturers could sell to the equipment owners or independent service organizations the proprietary replacement parts, service tools, and calibration test equipment that is specialized for devices. They are entitled to charge a reasonable price. But servicers need access. And we don't want them to lose their intellectual property or the money they invested in to creating these pieces.
  4. Servicers can reach out to their local representatives, write letters, organize, and ensure the healthcare industry has the ear of legislators. Healthcare is a highly specialized field, said Wang. Sometimes legislators need to hear from us.

Let's take up the challenge, said Wang. Let's challenge the status quo with audacity. We must think outside the box.

  1. FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices In accordance with Section 710 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA)

May 21, 2021

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