We at TRIMEDX are encouraged to see the introduction of the proposed Critical Medical Infrastructure Right-to-Repair Act, as announced on August 6th, 2020 (the “Bill”). The COVID-19 crisis has created many challenges for health systems and reinforced the need for improvement in healthcare.
The proposed Bill includes many important provisions. Here is a flavor of a couple of these provisions:
- Requirements for manufacturers to provide, on fair and reasonable terms, access to information and tools used to diagnose problems and service, maintain, or repair equipment.
- Requirement for the Federal Trade Commission to evaluate the bill’s impact and effectiveness on innovation and competition in the critical medical infrastructure market.
While opponents of this legislation cite concerns over quality control measures and ongoing patient safety, a 2018 FDA report, as part of a year-long study, concluded that third-party ISOs “provide high-quality, safe and effective servicing of medical devices”.¹ This includes providing service to rural areas that that OEMs may not be able to reach because of strained staffing resources brought about during periods of increased demand, such as during the pandemic. Moreover, the Bill equally benefits in-house hospital service teams by ensuring access to tools, keys and manuals that are withheld by some manufacturers.
Advocates for rural healthcare are also encouraged by the introduction of this bill, stating that the legislation is “common-sense” and will prioritize patient’s safety over proprietary concerns.”²
Both TRIMEDX and The Alliance for Quality Medical Devices, of which TRIMEDX is a founding member, are in full support of this bill, which aims to eliminate barriers to servicing medical equipment and ensure that healthcare providers have reasonable options on how to safely and effectively service their medical equipment .
¹FDA FDARA Report
²InsideHealthPolicy: Device Servicers, OEMs Spar Over Wyden’s Right-To-Repair Bill, August 14, 2020