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COVID-19 and a BMET’s right to repair

August 14, 2020
HTM Parts And Service
From the August 2020 issue of HealthCare Business News magazine

By J. Scot Mackeil

Just as 9/11 changed the way the world looks at travel and security, the “new normal” after COVID-19 will require changes in the ways we do many things, particularly in healthcare.
Access to sensitive patient care areas by non-hospital employees will be more limited as stricter visitor entry protocols, entry point screening, and hand hygiene and mask policies become more commonplace. Does someone really need to be there? Are they an exposure risk? Have they recently been in contact with others that may have given them an infectious disease? Could they be a silent carrier of COVID-19?

Historically, a wide array of manufacturer and third-party medical technology service providers and technical sales reps have had almost unlimited access to the most sensitive areas of hospitals to service and/or support products and technologies there. In many cases they will visit multiple facilities on a single day, stopping for a meal between visits, or perhaps taking public transit. These individuals are not part of the hospital’s rigorous occupational health surveillance systems and as such, service visits by non-hospital-based service providers carry recognizable control risks.

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Fully enabling our hospital's in-house technology support staff to support, repair, maintain, upgrade, and install essential technologies will go hand in hand with keeping our healthcare technology workforce safe and healthy. Our national and global medical equipment manufacturers, and the powerful lobbies that represent their interests, must understand this, and put patient safety ahead of service and revenue models designed to exclude hospital-based service providers from support, repair, and maintenance of their medical technology. That will mean collaborating more constructively with hospital-based biomed, clinical, and healthcare/IT engineering departments and their third-party partners.

To support these efforts, the FDA could adopt NFPA-99 by reference as CMS did in support of the healthcare sector. They could also formally define “product labeling”, also known as “service manuals”, and clearly signal to manufacturers that providing service information and designing service models that are equitable and inclusive, is required, and that locking hospitals out of servicing their own technology is not an acceptable practice.

Use of in-house or on-site hospital technology service providers creates a much lower risk for infection prevention strategies because they’re well vetted and are under the organization’s occupational surveillance and health screening programs. They know and practice the institution's infection control and access control procedures.

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