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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

In the clinical environment, equipment downtime can have broad effects on patient care and safety. If a mission-critical system is down, ripple effects spread across the hospital where care must be rescheduled, delayed, modified or not provided. Why should a hospital have to wait for an outside technician to repair a device when its own biomed department could do the job more quickly and without the added risk of infections?

Ventilators as an example
Recently, in the context of COVID-19, some manufacturers have curtailed field service operations, leaving hospitals to either stop using a device, or perform patient care using a device that is past due for scheduled maintenance.

In the second week of April, I was tasked with assisting the Massachusetts Emergency Management Agency with functional screening of ventilator shipments coming into the state from the federal stockpile. I found one unit with a crushed DC power plug and was asked by a state official if I could repair it due to the urgent need. I replied that I could, after all, it’s a simple “remove and replace” repair for any BMET. Yet, when contacted, the manufacturer refused to send a part overnight to get this ventilator on the front lines.

Their representative was adamant that regardless of my years of experience as a senior BMET, I was not “qualified” to buy the part and perform this simple repair because my organization had not paid for me to attend their service training school. The rep insisted they could not and would not make any exception to their policy including for urgent medical need during the COVID-19 pandemic.

Ventilators have long been a core competency for in-house biomed programs. Yet increasingly, OEMs have locked hospital-based providers out of the devices with digital encrypted service keys, charging exorbitant fees for “service schools”, bundling inexpensive individual parts into expensive “field replaceable units”, and by blockading access to repair and maintenance parts and information. The same can be said of other key device categories such as ultrasound machines, lasers, X-ray systems, lab analyzers, anesthesia machines, surgical systems and many more.

In one case I have experienced, a company charged my hospital nearly $5,000 for an annual visit to do a preventive maintenance (PM) check on what is essentially a 4-channel bipolar electro-surgical unit. The rep drives from an adjacent state, uses a digital service key to access service mode, attaches a resistor network box to the device, generates energy in each treatment mode, writes down the observed values and reviews log files, and 20 minutes later, completes his report. He only “worked” in the hospital for 30 minutes, but the majority of his cost is the travel charge.

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