For Hospitals and Patients, We Need New Medical Device ‘right to Repair’ Laws

Medical equipment can be sold with a manufacturer-imposed restriction that only the manufacturer can make certain repairs. Unfortunately, this means when medical equipment breaks down, a delay of hours or days might occur despite the availability of qualified trained technicians. This situation can have an impact on patient safety and raise costs for hospitals.

Crothall Healthcare is one of many healthcare technology organizations fighting to address this problem. “Right to Repair” is a movement that supports the right for owners to maintain medical devices and other equipment such as tractors, cell phones, and home appliances. “Right to Repair” advocates for the availability of parts, tools, diagnostic and service manuals to maintain equipment. You may be surprised to learn that some medical equipment manufacturers limit access to critical parts, tools, and diagnostic equipment.

Fortunately, momentum is moving in our favor on several fronts. In May, the Federal Trade Commission published a report titled “Nixing the Fix: An FTC Report to Congress on Repair Restriction.”  The FTC found that there is “scant evidence to support manufacturers’ justification for repair restrictions.”

Crothall and its trade organizations are hopeful that this report will lead to legislative action. New laws have been proposed in 25 states that would require medical device manufacturers to provide critical parts, tools, and diagnostic materials to hospitals and independent biomedical companies. Crothall is a member of the coalition, the Alliance for Quality Medical Device Servicing.  The Alliance supported the efforts of Senator Ron Wyden D-Ore and Rep. Yvette Clarke D-NY in their efforts to introduce the Critical infrastructure Right-to-Repair Act of 2020 in response to needs during the COVID-19 pandemic.

Why are we so adamant about our position on this issue?  Here are five reasons:

Hospitals should have the right to choose how their medical equipment isrepaired. Crothall manages and services one million pieces of medical equipment for more than 175 hospitals nationwide. We firmly believe our clients want high-quality, cost-competitive options to maintain their investment in medical devices. This was crystal clear during the pandemic when Crothall directly supported our clients to maintain their medical equipment, often helping save patients’ lives.

Hospitals seek companies that can provide services that maintain equipment during the entire life cycle of their equipment. And that’s what Crothall does. Without any bias toward the maker of medical equipment, we assist in equipment assessment and support corrective and preventive maintenance needs. We also protect devices with cybersecurity solutions and extend the useful life of equipment.

We maintain the highest standards and meet regulatory and compliance laws. We lead by example. In 2019, we achieved the ISO 13485:2016 Quality Management System certification. Our registration scope is as a full life cycle medical device service provider, offering equipment management, technical support, and OEM equivalent repair services of clinical and diagnostic equipment nationwide.

Crothall, along with members of the Alliance for Quality Medical Device Servicing, meet or exceed hospital system accreditation standard requirements and elements of performance.  We are seamlessly held to and measured by Centers for Medicare and Medicaid Services, as well as all “deemed status” accrediting agency standards without any consideration for our role as subcontractors.  standards without any consideration for our role as subcontractors.  

We invest in our technicians’ development and evaluate their competency annually.  We provide on-site experts and field service engineers who are highly responsive to our clients’ needs. In addition to education, we invest in training for our associates to become certified as Biomedical Equipment Technicians, and Certified Radiology Equipment Specialists.

Helps Lower Healthcare Costs. Lack of access to local repair options can be a major hurdle for hospitals trying to save lives.  When the manufacturer is the only option to repair medical equipment, it raises costs for hospitals.

In addition, we are motivated by service outcomes – not equipment sales. We repair all equipment with an unbiased opinion; we recommend what a hospital needs, not what equipment we want them to buy. Our capital recommendations are based on performance metrics, and equipment life cycles are extended with our predictive repair modeling without any additional charges.  As equipment life cycles are extended and up-time is maximized, you can squeeze every dollar out of this significant investment.

Original Equipment Manufacturers (OEMs) must provide the necessary documentation. Our clients look to us as a member of their team. We assist our clients in managing working relationships with the makers of medical devices and equipment. For example, if new technology is still under warranty or a service agreement, we are still responsible for managing the OEM relationship from a clinical engineering perspective. We work closely with OEMs on our clients’ behalf and value our OEM relationships.

However, restriction of Service Manuals and other service information may limit the transfer of knowledge, thus creating risk.  Availability of materials aligns with actions already in place in the European Union. We believe this can be done without disclosing proprietary technologies while making it easier and faster to repair critical medical equipment.

We realize that manufacturers have invested millions of dollars to develop and produce highly efficient equipment for our nation’s healthcare systems. Allowing us to repair their equipment does not erode their incentive for innovation.

In the end, we take seriously our responsibility to repair our clients’ medical devices. Together, we have a singular focus:  providing safe medical devices for the best patient care. Giving us the right to repair all medical devices and equipment will help achieve that goal.