Right to Repair and Single-Use Device Reprocessing

Is Patient Risk Too High for Healthcare to Discuss Re-Use?

The Right To Repair movement has been successful at the state level in raising awareness about the financial, environmental, and ethical benefits of allowing consumers to seek repair and re-use for products – from watches to computers. At the white house level, this has been lauded as an important aspect of increasing competition, which helps and grows the economy overall. President Biden’s executive order, “Promoting Competition in the American Economy” came with a 72-item fact sheet to outline how this is to happen. The order goes as far as to encourage the FTC to rule against anti-competitive restrictions to repairs and re-use. However, healthcare products were not included in this. In terms of healthcare, prescription drugs, hearing aids, hospital consolidation, and health insurance are singled out. While in agriculture – for example – equipment repair is addressed, there is no mention of instrumentation or equipment in healthcare, although manufacturer restrictions on re-use of healthcare devices severely dampens competition and increases costs.

The ICE – Advancing Imaging Professionals – online magazine outlines this situation in an excellent piece from July 14th. The author also explains how MITA (the Medical Imaging & Technology Alliance – a technology manufacturers’ association) celebrates this exclusion of medical instrumentation from the order by pointing to the categorial difference to medical device equipment, which would “raise both patient and cybersecurity concerns”.

On September 1st,  Jarone Lee, MD, MPH, FCCM, Editorial Board Member of BMC Anesthesiology and Associate Professor at Harvard Medical School and Director of the Blake 12 ICU at Massachusetts General Hospital reflected on the order and what it is missing in terms of Right-to-Repair in the medical field. He considers the linear supply chain paradigm in healthcare unsustainable – financially and environmentally. Dr. Lee, in fact, believes that Right-to-Repair regulation “is expected to allow the healthcare sector in the US to become more sustainable, environmentally-friendly and affordable”. In terms of the success, though, of Right-to-Repair approaches in healthcare, three main challenges exist: 1) Patient safety (regulations and standards are important here); 2) cybersecurity (patients’ privacy, etc.), and 3) the need to leave room for healthcare innovations (adaptability). To overcome these challenges, manufacturers need to stop building planned obsolescence into the design process, manufacturers need to make parts and technical knowledge available for repair processes, products should be designed for repair and re-use, and reuse equipment needs to be subject to strict rules and regulations – standards need to match those manufacturers follow. 

 

...Right-to-Repair regulation “is expected to allow the healthcare sector in the US to become more sustainable, environmentally-friendly and affordable”.

 

Dr. Lee’s observations are extremely helpful in getting past the MITA commentary about patient concerns. I suspect healthcare products are precisely not included in the order’s fact sheet because healthcare products are considered too dangerous to mess with in terms of re-use. However, this is an antiquated notion, and it is disappointing that the President’s order ignores established healthcare re-use practices that pose no elevated patient risk and follow manufacturer standards. MITA’s comment is similarly ignorant of the fact that the same characteristics of the category they call out (patient safety and cybersecurity) HAVE BEEN EXHAUSTIVELY ADDRESSED in regulation that is specifically about medical devices and re-use – and that has been widely used in healthcare for the past 20 years!

Single-use device reprocessing has been regulated since 2000 and is closely governed by FDA procedures and rules. The practice of single-use device reprocessing entails collecting used single-use devices at the hospital, then tracking, cleaning, testing, and sterilizing the devices, before they are made available to the hospitals for a second use. The practice reduces the number of devices that end up in the landfill, it builds a more resilient supply chain, and it saves hospitals hundreds of thousands of dollars per year – sometimes more. Single-use device reprocessing is probably the single most successful circular economy solution in healthcare and could appropriately be used as a model for how the administration and the industry adopt these principles – without compromising patient safety and following appropriate standards.

 

Single-use device reprocessing has been regulated since 2000 and is closely governed by FDA procedures and rules.

 

Yes, healthcare products ARE “categorically different” from tractors and consumer electronics. Yes, re-using medical devices requires strict regulation. Yes, patient safety is a concern. But that doesn’t mean the practice shouldn’t be right in the center of any administrative initiative about competition, the environment, and the desperate need for cost savings in healthcare. It is time for the administration and the industry to become better informed and catch up with key healthcare practices that could become a model for solving all of the issues brought up by Dr. Lee.

 

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