Nowadays, it is virtually impossible for healthcare workers to deliver care to patients without medical devices[1]. These devices must not only be safe and effective, as required by FDA regulations, but also constantly available to avoid delays and transfers of patients to other healthcare delivery organizations - HDOs (i.e., hospital on “bypass” or “divert” status).
Some medical devices are only usable once (aka “single-use” or disposable[2]) or for a single patient (e.g., implants) but a significant portion of them are reusable for multiple patients. These reusable devices—called “medical equipment”—are often expensive and require service (scheduled maintenance and repairs). HDOs typically depend on a combination of hospital staff, independent service providers (ISPs) and field service representatives of the respective original equipment manufacturers (OEMs) to ensure its medical equipment is safe and reliable.
Due to the vast American geography and limited staff availability, OEMs are often unable to provide prompt repairs and regular maintenance on time. Some OEMs have trained and provided service material[3] to HDOs and ISPs, but some other OEMs have been reluctant to cooperate alleging several concerns (see below). The critical nature of medical equipment service became clear during the COVID-19 pandemic when millions of lives depended on the availability of ventilators, pulse oximeters, infusion pumps, medical imaging equipment, etc. At that time, OEM service representatives were not allowed to travel and/or visit HDOs, so the service of medical equipment fell entirely on the shoulders of hospital-based clinical engineering (CE) (aka healthcare technology management - HTM) professionals employed by HDOs or ISPs. Fortunately, those reluctant OEMs agreed to release service material to allow CE/HTM professionals to fill in the gaps. Unfortunately, after the end of the pandemic, those reluctant OEMs reverted to their original position of denying the provision of service material[4].
In essence, the “Right to Repair” (RtR) movement for medical equipment seeks access to service material to ensure medical equipment is safe and reliable for prompt and effective care delivery. This is especially essential for people located in rural and remote areas which have been struggling to survive over the last two decades[5] and many of them are at risk of closure[6]. Even for HDOs located in metropolitan areas, RtR allows them to keep using the medical devices safely and effectively much longer than their estimated useful lives, thus avoiding premature replacement and saving precious investment capital for HDOs[7]. Furthermore, by extending the device useful lives, it is possible to help contain the rise of healthcare costs, reduce toxic waste and lessen detrimental impact on the environment.
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Footnotes:
[1] FDA’s definition of medical devices is available at https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device
[2] Some single-use devices can be reprocessed. For more information see https://amdr.org/
[3] Service material is understood as technical specifications, service manuals, diagnostic and calibration software access, proprietary parts and test tools, etc., needed to provide scheduled maintenance and repairs to ensure safety, effectiveness and reliability.
[4] See the results of 2026 survey of CE/HTM professionals by PIRG https://pirg.org/edfund/resources/hospital-repair-restrictions-ii/
[5] A Rupasingha & J Cho, 146 rural hospitals closed or stopped providing inpatient services from 2005 to 2023 in the
United States, USDA Economic Research Service, available at: https://ers.usda.gov/data-products/charts-of-note/chart-detail?chartId=110927
[6] M Topchik et al., 2026 rural health state of the state, Chartis, available at: https://www.chartis.com/insights/2026-rural-health-state-state
[7] Wang et al. Medical Equipment Aging, Part II—Impact on Lifespan, J Clin Eng, 49(3):87-96, 2024. available at: https://journals.lww.com/jcejournal/abstract/2024/07000/medical_equipment_aging__part_ii_impact_on.11.aspx
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