The Hidden Risks in Third Party Medical Device Servicing – A Conversation

On April 17, we hosted a webinar focused on the relationship between the right to repair movement and the integrity of the more than 24,000 medical devices used in our healthcare system today. With this initiative gaining traction in state legislatures nationwide, lawmakers are aiming to enhance consumer rights by facilitating easier access for individuals to repair their own devices. But there are inherent risks of implementing broad policies that could ensnare products like medical devices that are directly connected to public health.

Tirzah Duren, President of the American Consumer Institute, and Peter Pitts, former FDA Associate Commissioner, participated in a panel and discussed the important nuances that make medical devices a product that needs to be exempt from this type of policymaking.  

Tirzah Duren introduced the conversation and stressed the importance of informed decision-making: “Lawmakers really fail to recognize the risks of some of these overly broad right to repair policies.” She also argued that this could “jeopardize quality and overall patient safety.” 

Peter Pitts provided his expert insights as a former regulator, speaking to the dangers of unauthorized medical device repairs. “These devices are not personal digital systems,” he emphasized. “They are life-saving technologies where the precision of data reporting is crucial to providing medical care.”

The discussion highlighted the intricate challenges involved in allowing unregulated third-party servicers to maintain medical devices. Pitts cautioned, “If you go to the hospital and a medical device designed for lifesaving purposes fails, it poses a serious issue.”

Both Duren and Pitts backed a more nuanced approach to right to repair legislation, specifically suggesting carve-outs for medical devices. They emphasized that patient safety should precede broad legislation without medical device carveouts.

The key message from both speakers was clear: While right to repair might work for consumer goods, medical devices should be considered separately as they are specialized and regulated to protect human lives.