The right of Hospitals to repair– or to choose who will repair their own medical devices is integral to patient safety and to controlling costs. Never was this more apparent than during the Pandemic. Healthcare systems continue to face the existential challenge of sustained cost increases. As the American Hospital Association has noted, the financial stability of America’s Hospitals is at risk as the cost of care continues to rise.1 Among the many increases for hospitals to watch, are hospital equipment repair and maintenance costs.

When hospitals have choices for servicing and parts, hospitals enjoy competitive pricing, accountability and in most cases better service. However, some device manufacturers impose restrictions such that only the manufacturer can make certain repairs. The position of some manufacturers— that only they can safely repair medical devices is unsupported and …….in many ways ‘demeaning’. There is most often in place a hospital ecosystem dedicated to patient safety including clinical engineers, procurement teams and EOC committees. All are available and dedicated to qualify and supervise those who service their medical devices.2 Reports to the FDA of adverse events in the repair and service of devise are under 1%. Independent servicers are vitally important to this health care ecosystem.  As the U.S. Food & Drug Administration noted in its 2018 Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices, “[t]he continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system.”

Hospitals and independent servicers should be able to service a device without restrictions to access the necessary software tools. Moreover, the use of independent servicers to repair medical devices, does not pose a cybersecurity threat. As the FDA has noted in connection with the U.S. Copyright Office’s  approval of an ‘exemption to access computer programs’ that control the functioning of medical device systems for diagnosis, maintenance and repair, the FDA “does not share the view that an exemption from liability [for repair information]….would necessarily and materially jeopardize the safety and effectiveness of medical devices in the United States with respect to cybersecurity.” 3 As the Registrar of U.S. Copyrights concluded in its 2021 decision approving exemptions for medical device repair, the safety and cybersecurity arguments presented by manufacturers to restrict access are not supported.

Consistent with promoting and protecting the public health, IAMERS seeks to encourage as an industry best practice that manufacturers provide servicing instructions that facilitate routine maintenance and repair of their reusable devices. Labeling of medical devices should include the following information, as applicable, to facilitate the routine device maintenance and repair:

  • A description of the key performance and safety specifications;
  • Critical technical or functional specifications, including:
  • Physical dimensions;
  • Electrical characteristics, including batteries (e.g., chemistry, amperage, voltage, rechargeability), internal fuses, and power supply (e.g., voltage, amperage, frequency); and
  • Device-specific performance specifications (e.g., flow rate accuracy or range, humidity, temperature, wavelength),
  • The recommended maintenance activities and schedule;
  • Recommended routine testing and acceptance criteria to confirm that the device remains within its performance and safety specifications;
  • A description of error codes, alerts, and alarm features on the device;
  • Precautions and warnings relevant to servicing the device; and
  • Version number and release data of software.

(Source: FDA Draft Guidance on Remanufacturing for Industry and Food and Drug Administration Staff) 4

Bottom line: Hospitals (and the servicers they choose) should have a right to repair the devices they own. In the event that a manufacturer does not cooperate with respect to releasing access to the above information, there should be legal consequences for the withholding of this cooperation.

 

1  https://www.aha.org/costsofcaring#:~:text=A%20confluence%20of%20several%20factors,hospitals%20since%20the%20pandemic%20began
2  https://www.fda.gov/media/113431/download
3  https://www.copyright.gov/1201/2021/USCO-letters/Classes-9-and-12-Ex-Parte-Meeting-Summary-FDA.pdf
4  The Remanufacturing of Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff, (page 17) lists the servicing instructions infra and “encourages OEMs” to provide this information. Many believe that the FDA has sufficient authority under Section 502(f)(1) of the FD&C Act and 21 CFR 801.5(g) pertaining to ‘adequate instructions’ for use to’ mandate’ this information be provided. There are also specific additional instructions promulgated for radiation emitting devices. See 21 C.F.R. 820.170 + 21 C.F.R. 1020.30.