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.

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.

A contradictory business model
There are many medical technologies in hospitals that can readily be serviced by the hospital-based biomed, IT, and facilities staff, but often are not. This is because, for manufacturers, service and maintenance represents one of their most lucrative revenue streams. They have designed digital, physical, engineering, and mercantile controls to prevent hospital-based technical staff from providing basic servicing to many hospital-owned critical devices.

Imagine if you, your local mechanic, the AAA employee, and the corner gas station attendant were all unable to change your car’s oil, replace your battery, change your tires, or open your hood to put in a new air filter? This is essentially the case for many of our country’s hospitals with respect to many mission-critical medical technologies.

When a manufacturer’s service model excludes the hospital-based biomed staff from device service, requiring a member of their company’s service staff to enter the hospital, they are creating unnecessary risk solely in support of their financial objectives. This is far from an optimal approach to providing technology support services in conjunction with the hospital’s infection control imperatives. This also contradicts the statements of manufacturer trade groups, which often claim to be motivated entirely by patient safety.

There will be cases where the hospital’s in-house or on-site biomeds will not be able to repair or support certain essential technologies without the help of manufacturer-based or third-party service company staff. But in many cases, the first level of service support could be done via mobile phone and/or video chat using the in-house BMET as the on-site resource. Good service technicians can talk their fellow service professionals through many types of problems and level one physical repairs. Only when internal providers reach their limit should external providers be carefully brought into the hospital to provide services.

This common sense approach is more aligned to hospital infection control practices and an example of what the “new normal” in medical device service must evolve to. We must also consider ways to reduce service done by shipping and receiving devices that in-house biomed departments can repair. Boxes and parcels should not go in or out of the hospital unless necessary. Therefore, manufacturers should curtail the use of mandatory “ship it to service it” models and collaborate more extensively with hospital biomed departments and technical staff to repair equipment at the BMET’s workbench.

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.

This $5,000 spent on the back end has offset nearly $20,000 in front end hospital income from patient, insurance company and government payers. I am well skilled in energy device support and PM, and could easily do this PM in 30 minutes for a vastly lower cost to the healthcare system. Avoidable costs like this compound daily in hospitals everywhere. Most, if not all BMETs can share similar experiences.

Collaborating to bring real value to hospitals
The “right to repair” issue has been dividing hospital-based service providers and medical equipment manufacturers for some time now. Key turning points occurred when CMS incorporated NFPA-99 by reference and when the FDA issued the May 2019 FDARA 710 report that found that medical equipment repair by hospital biomeds and third-party companies was safe, effective and essential to the healthcare industry. It would also be very helpful if our nation’s FDA were to adopt NFPA-99 by reference and support the fair-trade concepts presented in this article and modify their regulatory frameworks in support of these concepts.

Materials management groups should also become more actively involved in securing the hospital’s right to repair by stipulating that access to parts, service manuals and digital service keys be provided as a condition of purchase in all purchase orders. These should be featured components of all vendor agreements. Vendor access systems should have visiting sales reps attest they understand these requirements and accept these terms on behalf of their company. There should be clear and open channels healthcare technology managers can use to communicate to materials managers in cases when a vendor has not met these key elements of the purchase order, and implement any steps needed to bring the vendor into contract and/or regulatory compliance.

COVID-19 and the danger of spreading deadly infectious disease has provided further evidence of the need to move away from the existing medical device service paradigm and toward greater support for hospitals and their in-house service teams. It is my hope that by working together, lawmakers and regulators will usher in a new era where equipment manufacturers and in-house service teams partner with the basic goal of improving patient safety and reducing healthcare costs.

About the author: J. Scot Mackeil is a CBET in Quincy, Massachusetts, and the 2018 AAMI BMET of the Year.