Hospital Repair Restrictions II

Conducted in December 2025 and January 2026, our survey of biomeds gives an updated look at the challenges in fixing medical devices. Preliminary interviews encouraged us to examine if restrictions that eased during the pandemic had returned, and to what extent; as well as to examine the impact on patient care that results from various types of repair restrictions. 

In our survey, we sought to closely examine the impacts of repair restrictions on equipment downtime, and situations where that can lead to a delay in patient care.

Manufacturers justify restricting repair because of patient safety — they argue that restricting repair to their authorized servicers increases the quality of repair work, and prevents improperly repaired devices from impacting patients. Meanwhile, repair advocates have long argued that refusing to give hospitals what they need to service equipment creates its own  safety risks. We asked hospital repair technicians about their views on these issues. 

Lastly, we wanted to look more closely at the impact of repair restrictions on rural hospitals, which have become an area of concern. According to the USDA, between 2005 and 2023, 146 rural hospitals have either closed or stopped providing inpatient services. More than 700 rural hospitals are at risk of closing, with 300 considered at “immediate risk.” These closures can have a profound impact on healthcare in regions where people already have few options. 

Takeaways from our investigation and survey show that software barriers to repair can lead to delays in patient care,  biomeds in rural healthcare facilities report experiencing more delays from manufacturer repair restrictions, and that a higher proportion of biomeds are reporting that they have been denied access to service information than in 2020.

More robust repair options help hospitals keep equipment running. But when the device requires software or other materials that only the manufacturer’s authorized personnel have access to, that can mean waiting on the manufacturer to complete repairs. 

When asked, “How often does waiting for repair materials such as parts, service keys, and service manuals for a medical device increase equipment downtime?” 50 (47%) responded “somewhat frequently” while 38 (36%) responded “most of the time” — for a total of nearly 83% (88 of 106). Only 17 (16%) say this happens “sometimes, but infrequently,” and just one person responded “I have never had this happen.”  

Respondents were asked “How often do you experience these servicing restrictions causing a delay in prompt patient care?” for different kinds of repair restrictions – software / password locks, diagnostic tool restrictions, and a lack of access to service manuals, spare parts or training. In all five categories, the most popular answer was “Experience commonly,” underscoring how repair delays can impact patients. 

The highest frequency for delays in prompt patient care was reported for “Manufacturer imposed software locks/passwords” and “Restricted access to diagnostic tools and information,” both of which related to software-related restrictions. Of the biomeds who took our survey, 75 (70%) indicated that they experience diagnostic tool restrictions “commonly” delaying patient care, while 73 (68%) say that software locks and passwords “commonly” delay patient care. 

We examined the difference in answers based on how often the respondents service rural providers: 36 (34%) of respondents serviced rural providers “All the time” or “most of the time” while 70 (66%) either serviced rural providers “sometimes” or “never.” Comparing these two groups, you can see the disparity in the impact  of repair restrictions on patient care.  

Biomeds who mostly serviced rural providers were more likely to “commonly” experience delays in prompt patient care, compared to those who don’t typically service rural providers. Respectively, they reported delays caused by: software locks or password (83% vs. 61%), restricted access to parts (53% vs. 38%), restricted or inaccessible device-specific trainings (54% vs. 41%), restricted access to diagnostic tools (78% vs 66%), and restricted access to service manuals (64% vs. 57%).

Because of budget constraints and geographical distance from manufacturers in metropolitan areas, rural hospitals often have small in-house teams maintaining their equipment, have less equipment redundancies, and might not be able to pay for servicing contracts.  

One HTM interviewed by U.S. PIRG  Education Fund who services  rural hospitals (and asked to remain anonymous), told us that “if a rural hospital in upstate New York needs their CT scan fixed, but the OEM contract gives them two days to arrive to service the equipment – that is not good for the patient,” which is why many hospitals buy multiple pieces of expensive equipment to prevent interruptions in care.

In 2020, 64% of surveyed technicians (141 of 219) reported being denied access to service information for critical equipment (“defibrillators, ventilators, anesthesia machines, imaging equipment, etc.”) either “somewhat frequently” (48%) or “most of the time” (17%). 

Our latest findings show this trend is increasing. 

A total of 79% (84 of 107) reported being denied access to this service information “somewhat frequently” (48%) or “most of the time” (31%). The most frequent response was “somewhat frequently (48%),  and the second most frequent response to this question was that manufacturers would deny access to service information “most of the time” (31%).

None of the respondents in our recent survey reported that they had “never” been denied information for critical equipment, versus 9 (4%) of respondents in 2020. 

Taken together, responses to these two questions imply that the situation is currently worse than it was in 2020 — that any trend which might have improved due to more pandemic-related cooperation has reversed.  

When a manufacturer stops producing a particular model of device, it sends an End of Life (EoL) notification. The manufacturer can also set an End of Service (EoS) date when it terminates all support activities for that model of device. The manufacturer determines the date when they stop producing or providing support for a certain model, and these notifications are often used to encourage hospitals to replace equipment.

When hospitals have access to the documentation and software for this equipment, qualified personnel can extend equipment lifespans without affecting quality of patient care. We asked biomeds how often they “service devices which have reached their ‘End of Life’ (EoL) and are no longer supported by the manufacturer?”

Every single survey respondent reported servicing unsupported devices to some degree, and 82 of 107 (77%) reported to “Often” servicing such equipment. For technicians who spend most or all of their time working in rural hospitals, the rates are slightly higher, with 81% reporting they “often” service EoL equipment no longer supported by the manufacturer.

Prolonging the useful life of medical equipment is a fundamental part of the work of biomeds.  When determining the serviceability of medical equipment and thinking about capital replacement, biomeds and HTM professionals account for many factors beyond the age of equipment, such as “…safety, physical condition, supportability, and clinical impact.” The FDA pointed out that third party servicing of medical equipment is high quality, safe, effective, and critical to the functioning of the US healthcare system. 

It is common for hospitals to use equipment past its EoL or EoS date. Maintaining this equipment is critical to ensure safe and effective patient care. 

The pandemic put incredible pressure on the world’s healthcare systems, and, in response, some manufacturers eased restrictions on servicing information for critical equipment. As one respondent wrote, during the pandemic, “the manufacturers did not want to come in [for service calls] so they were very helpful.” Things appear to generally be moving back toward more restriction. 

The plurality of surveyed biomeds view the situation as getting worse in recent years: 49 of 107 respondents (46%) of respondents said that manufacturers have become “somewhat” (32%) or “a lot” (14%) more restrictive since the height of the pandemic in 2020 and 2021. Meanwhile, only 11 of 107 respondents (10%) said that manufacturers had eased restrictions “somewhat” (9) or “a lot” (2) in that time. Approximately a third (35 of 107) see the situation as “the same” as it was during the pandemic, while 12 (11%) answered “N/A – Not sure.”

We asked survey takers: “In your view, what is the relationship between the right to repair (access to parts, tools, information on reasonable terms) and patient safety and prompt patient care?” 

Given how commonly restrictions are reported to delay patient care, it is perhaps unsurprising that 94% (100 of 106) respondents selected “Right to Repair reforms would improve patient safety and prompt patient care by ensuring there are multiple options for service and properly informed technicians.” Meanwhile, only two respondents selected “Manufacturers protect patient safety and prompt patient care by restricting access to repair materials.”

According to a PartSource Survey of HTMs in 2024, the HTM industry’s labor shortage is the largest challenge facing the field. In a survey by the Association for Advancement of Medical Instruments (AAMI),  47% of the HTM respondents were over the age of 50. As Danielle McGeary, the Vice President of HTM at AAMI, told 24×7 magazine, training programs are becoming less common: 23 states currently lack BMET-specific academic pathways. An aging workforce coupled with this reduced pipeline of new technicians could result in fewer technicians being available for hospitals to maintain and manage their equipment. McGeary told 24x7mag that “people is the number one issue in HTM.” 

Shortages in the biomed workforce and decreased academic pathways highlight the importance of making sure OEM, in-house, and independent servicing professionals have all the necessary tools in their disposal to service and maintain hospital equipment. Repair restrictions reduce the number of people equipped to handle repairs on various devices, further throttling the supply of repair technicians. 

Some opponents to medical Right to Repair assert that third-party servicers — which assumedly would include both hospital-based biomedical teams and ISOs — are “unregulated,” and that the “lack of regulation of third-party servicers has the potential to harm patients.”

In reality, the hospital environment is highly regulated, including the repair of medical devices. Medical equipment must be approved according to stringent standards set by the FDA, and is subject to rules under the National Fire Protection Agency (NFPA), the Occupational Safety and Health Administration (OSHA), and hospital or Accreditation Association for Ambulatory Health Care (AAAHC) standards. 

Hospitals are regularly audited by accrediting organizations to meet Center for Medicare and Medicaid Services (CMS) Conditions of Participation (CoP). Meeting these conditions is required to participate in funded programs through Medicare and Medicaid  as stipulated in the Code of Federal Regulation.

The CoP says that “…[medical] equipment must be maintained to ensure an acceptable level of safety and quality.” This is interpreted by CMS as meaning the hospital must: acquire equipment to meet patients needs, ensure its availability, inspect and test all equipment before initial use and after any major upgrade or repair, ensure equipment is serviced by qualified personnel, follow manufacturer-recommended repair activities or schedules or, if eligible, adopt alternative activities/schedules, and keep records of personnel qualification for equipment maintenance. And while Independent Service Organizations (ISOs) are not required by the FDA to report serious patient injuries or deaths directly to the FDA, hospitals and manufacturers are required to do so.

In 2018, the FDA investigated whether additional regulation of independent repair was appropriate, finding that “the continued availability of third party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system.” 

Instead of finding safety issues, the FDA’s report 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.”

The FDA investigation cites a comprehensive study from the Emergency Care Research Institute (ECRI), which reviewed 2.1 million device incident reports submitted to the FDA from 2006-2015. According to ECRI’s research, only 0.005 percent of failures could be attributed to service or maintenance issues. The report concludes:

“Based on the results of ECRI Institute’s detailed database searches spanning the past 10 years, and on its monitoring of medical device problems and hazards for more than 40 years, we do not believe that a safety problem exists with the servicing, maintenance, and repair of medical devices by either third-party organizations or OEMs.”