Peter J. Pitts’ recent articles have made passionate but fundamentally flawed criticism of the tenet policies of expanding medical technology. Although all of us express concern about patient safety and device complexity in the healthcare field, his argument ignores key facts about the career in clinical engineering and healthcare technology management (HTM). It further misrepresents existing safeguards and qualifications for hospital-based professionals to serve medical equipment.
1. Clinical Engineering and HTM: A reliable record of safety and capability
For over 50 years, the hospital has safely and effectively maintained, calibrated and repaired its own medical equipment through trained biomedical equipment technicians (BMETs) and clinical engineers. These professionals are not amateurs of the “dust-flying toolbox” that the article implies, but are experts who stand out, certified and certified, with many decades of experience working directly with clinicians to ensure the equipment is safe and accurate at the point of care. Mr. Pitts’ ignorance of these professionals is dissatisfaction with the former FDA specialist, which means they are just some garage shops DIY Tinkerers both offensive and insulting, yet extreme.
Hospital-based HTM departments are guided by:
- Strict internal policies and procedures In keeping with CMS participation conditions and Joint Committee standards,
- Preventive maintenance plan This usually exceeds the manufacturer’s recommendations,
- Incident Investigation and Adverse Event Reporting Systemand
- Committed to continuous professional educationincluding OEM training and third-party certification.
In short, hospitals already have very capable internal and/or ISO teams that are able to do or higher at the level of many manufacturer service providers, and for decades they have been performing equipment maintenance with proven success and security. Ironically, unfortunately, the better these in-house technologists, the less visible they are. Perhaps one reason this HTM profession still hasn’t attracted attention.
2. Cooperation winning manufacturers
While some manufacturers limit service manuals, tools, and parts under the guise of “patient safety”, others choose to work constructively with clinical engineering teams. These forward-looking companies:
- Provide equipment-specific training to hospital staff,
- Provides layered and flexible service agreements,
- Supports open communication and troubleshooting,
- Respect the autonomy of hospitals while improving support efficiency.
These partnerships often produce faster response times, lower service costs, and better patient outcomes, especially in remote or resource-constrained hospitals, where waiting dates for OEM technicians can put life at risk. The service’s “lock box” approach destroys rather than supports care delivery.
These manufacturers have subtle yet profound added benefits in supporting their devices internally, often because their clinical users’ perceptions improve the device “always working.”
3. Accountability exists – can strengthen everyone
Mr. Pitts asserts that the Independent Services Organization (ISO) and hospital teams operate without supervision, neglecting the current regulatory landscape and opportunities for collaborative improvement. The hospital has been subject to detailed certification audits, whether it is any adverse event related to equipment failure caused by OEM or internal repairs.
If additional transparency is required, the solution is not to ban access, but requires all service providers including OEMs.
- Comply with minimum quality management standards,
- Participate in adverse event reports,
- Maintain documentation on service history and personnel capabilities.
This approach ensures unified accountability rather than choosing to apply it to non-OEM entities.
4. Cybersecurity and software issues: real, but easy to manage
This article correctly raises concerns about cybersecurity in a digitally connected healthcare environment. However, denying hospital access to diagnostic software or requiring an Internet “phone” tool that is controlled only by OEM is a security risk in itself. Hospitals must be authorized to ensure, audit and manage their own systems without being forced to rely on remote OEM gateways or opaque firmware.
A collaborative cybersecurity framework (rather than excluding service restrictions) is the way forward.
5. “Emergency Exception” Fallacy
Citing the distortion of the pandemic in 199 is misleading. The pandemic exposed is not that temporary policy relaxation is reckless, but that overly strict OEM control over maintenance puts patient care at risk. Hospitals are often repaired and reused in ingenuity, speed and care when they are raised. This is not an unsafe improvisation, but a reaffirmation of the value and reliability of the internal HTM professional.
Conclusion: Support hospitals, not monopolize
Hospitals should have the right to repair the equipment they rely on every day. Doing so is not a step back, but rather a reaffirmation of trust in skilled and firm professionals who have maintained the integrity of our healthcare system. They and their relentless, often invisible work really begins.
Photo: Janwillemkunnen, Getty Images
Dr. Larry Fennigkoh is currently an emeritus professor of the Biomedical Engineering Program at the Milwaukee School of Engineering. His main research and the work of forensic experts witnesses involves human factors and control of medical errors. Prior to joining MSOE full-time in 1998, Dr. Fennigkoh worked for 22 years in managing three different hospital systems in in-house clinical engineering and HTM programs.
In 2017, Dr. Fennigkoh was inducted into the American College of Clinical Engineering Hall of Fame for his pioneering work in developing the inclusion of medical device inventory that greatly reduces the maintenance and regulatory burden in many hospitals in the United States and abroad. Dr. Fennigkoh received his bachelor’s degree from the Milwaukee School of Engineering and Ph.D. University of Wisconsin/University of Milwaukee School of Engineering.
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