Celebrating 2025 Patient Safety Week

This week we honor Patient Safety Awareness Week – a time dedicated to discussing the importance of upholding safety in our healthcare settings.

It’s essential to recognize the multifaceted nature of patient safety. From clear, transparent communication among health care professionals to diagnostic accuracy, each aspect plays a vital role in safeguarding patients. However, amidst the myriads of considerations is the emerging topic of “right to repair” and its intersection with the medical devices that are foundational to patient safety.

Across the country, lawmakers are introducing bills designed to give consumers more autonomy in repairing the products they own. Although these bills vary widely and address a broad range of products, it is important to recognize that not all products are created equal. Legislation that includes or specifically targets medical devices could pose serious risks if medical devices are involved.

Imagine walking into a hospital, trusting that you’ll receive the best care possible, only to find out that an untrained and unregulated servicer was attempting to repair the medical devices involved in your diagnosis or surgery? Without proper oversight and regulation, there is a possibility of compromised device functionality, which could ultimately jeopardize patient safety.

The original equipment manufacturers (OEMs) for medical equipment are subject to the FDA’s Quality System Regulations (QSR); however, independent servicers are not. One FDA report identified about 4,300 reports in 2018 where a medical device was serviced by a third party. Of these reports there were 40 deaths, 294 serious injuries, and over 3,700 cases of a device malfunctioning. While this report identifies a potential cause for concern more transparency is needed before asserting causation and before creating a legal right to repair in this space. 

When it comes to medical devices used directly in patient care—from ventilators and infusion pumps to imaging machines—the stakes are incredibly high. 

As we observe this week, let’s prioritize informed discussions about medical device repairs and advocate for policies that protect patient welfare. Ensuring patient safety must be our collective responsibility; medical devices should remain exempt from right-to-repair laws because when it comes to health, we can’t afford any risks.