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Gus Iversen, Editor in Chief | April 07, 2026
A new report from the U.S. PIRG Education Fund finds that ongoing restrictions on medical device repair continue to affect hospital operations, with technicians reporting delays tied to limited access to parts, software and documentation.
The March 2026 report, based on a survey of 107 biomedical equipment technicians and healthcare technology management professionals, suggests the issue has intensified since the early stages of the COVID-19 pandemic. About 83% of respondents said repair barriers increase equipment downtime at least “somewhat frequently,” while 70% reported that restrictions on diagnostic tools commonly delay patient care.
Software-related limitations appear to be a central issue. Respondents most often cited password protections and restricted diagnostic access as frequent causes of delays. These barriers typically require manufacturer involvement, extending repair timelines.
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The impact is more pronounced in rural settings, according to the findings. Technicians serving rural hospitals reported higher rates of care delays across multiple categories, including access to parts, training and service manuals. The report links this disparity to resource constraints, smaller technical teams and longer wait times for manufacturer support.
The survey also indicates a rise in denied access to service information. Nearly 79% of respondents said they are frequently blocked from obtaining critical repair documentation, compared to 64% in a similar 2020 survey.
At the same time, many technicians report maintaining equipment beyond manufacturer-designated end-of-life periods. More than three-quarters said they often service unsupported devices, a practice the report describes as common and necessary, particularly in resource-limited environments.
Respondents broadly supported policy changes to expand repair access. About 94% said Right to Repair measures would improve patient safety and timeliness of care by enabling more service options.
The report also points to workforce challenges, noting an aging technician base and limited training pipelines. It argues that restrictions on repair resources may further constrain an already limited labor pool.
Federal regulators have previously found that third-party servicing does not pose additional safety risks, according to the report, which calls for policy changes to expand access to repair materials and reduce reliance on manufacturer-exclusive service models.
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Larry Worlitz
Proprietary Profits versus Patient Saftey
April 10, 2026 03:35
I have been in Biomedical Engineering since 1974. I witnessed both the HMO Act of 1973 and the Medical Device Amendments of 1976, which were game-changers. While it's hard to say "Regulation caused X% of all inflation," for an individual device moving from concept to market, 60% to 80% of the total capital required is now typically dedicated to satisfying the FDA's "Safety and Effectiveness" standards established in the 1970s.
This allowed the issue of profit ownership, as you can see among Medical Device Manufacturers. I have experience on both sides of this issue. I have always been entranced by how much politics affects the efficacy of patient care.
Medical Manufacturers are protecting their profits, and politicians have always seemed to agree with them.
Truly, if better patient care were the goal, Congress would pass a law requiring medical device manufacturers to release all passwords, technical documentation, diagnostic equipment required for compliance, fault tree analysis reports, and ensure that replacement parts are always available to the end user and third parties.
This should be their ante-up investment for doing business. They can charge a reasonable fee for access; however, they should not be allowed to a full sequestering for profit.
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