Medical Device Manufacturers are Getting a Hall Pass

At the 2026 CleanMed conference in St. Louis earlier this month, CHARME (Collaborative for Healthcare Action to Reduce MedTech Emissions), announced the publication of several workbooks produced during the Collaborative’s first round of work. Among these was a workbook about single-use device reprocessing that I had the honor to co-author – as an active member of CHARME. In contrast to the hospital-based reprocessing of reusable devices, single-use device reprocessing is done by third-party FDA registered reprocessing facilities – and in contrast to reusable devices, these devices are NOT designed to be re-used, and their manufacturers’ business model is based on these devices being thrown away after a single use.

The reprocessing workbook was a result of a uniquely collaborative effort to describe how hospitals may get more value from their reprocessing programs. Some sections in the book take the readers through case examples of successful reprocessing programs; others describe what hospitals can do to get better results; and yet others detail how reprocessors can make the reprocessing programs easier to manage for optimal results.

Later on the same day, David Sheon of the Association of Medical Device Reprocessors (AMDR) co-presented on the topic of single-use device reprocessing and detailed how one original manufacturer of single use medical devices had recently lost a lawsuit brought on by a third party reprocessor (the company I work for). This lawsuit was filed to combat the manufacturer’s policy of withholding critical technical support from procedures where the hospital used third-party reprocessed devices (to drive down costs and environmental harm), as opposed to devices from the manufacturer in question. Having discovered methods used by the manufacturer to thwart reprocessing – and having considered the damning language used by manufacturer representatives - the jury ultimately (in record time) found the manufacturer to be guilty on all counts, and later, the court issued an injunction to stop the policies and practices of the manufacturer. The lawsuit is currently under appeal.

CHARME is an initiative convening 40 health systems, medical device and equipment suppliers, distributors, GPOs, and industry experts and stakeholders. Several third-party reprocessors participate in CHARME, on reprocessing topics and beyond. The purpose of the Collaborative is to define, implement, and champion best practices to reduce emissions from the medical technology supply chain. CHARME addresses a gap in current initiatives focused on health sector supply chain sustainability. Greenhouse gas emissions from medical devices and supplies account for 7% of the health sector’s US footprint. An important premise in the CHARME Collaborative is that a multi-stakeholder collaboration is needed to decarbonize healthcare, and having all healthcare stakeholders working together provides efficiencies and innovation no single company or stakeholder can achieve alone. CHARME was co-founded by Kaiser Permanente and Vizient – and is convened by the Sustainable Purchasing Leadership Council, which is doing a fantastic job achieving the near-impossible – getting opposing stakeholders to collaborate on healthcare industry challenges to identify models that actually work, that actually make a difference.

We need more multi-stakeholder collaborative processes in healthcare. I sometimes wonder if people in general understand how close US healthcare is to collapsing. From an environmental perspective, healthcare is doing more poorly than any other industry to address global warming. From a financial perspective, an unsustainable cost equation; the One Big Beautiful Bill cuts expected over the next few years; record hospital closures; reimbursement rates that cannot follow the pace of pharmaceutical and technology costs; pressures from surgery centers and home care; staff shortages, etc. combine to make the near-future prospects for acute care institutions grim, at best. Programs like CHARME and HIRC, on the issue of healthcare resilience, are doing an amazing job pioneering multi-stakeholder initiatives, but it may be too little too late, and more organizations need to own that they are jointly responsible for the problems – and the solutions.

We need more multi-stakeholder collaborative processes in healthcare.

As mentioned, in the single-use device reprocessing workbook from CHARME, hospital systems and reprocessors have jointly owned that they need to make an effort to grow the environmental and financial results of single-use device reprocessing. The coincidence of the AMDR presentation at CleanMed shows the limitation: When manufacturers are allowed to stay out of the solution, they end up combatting hospital interests in the cost savings and environmental impact of device re-use. The single-use device reprocessing workbook from CHARME makes reprocessors accountable, and it makes hospitals accountable. What it DOESN’T DO is to make the original manufacturers accountable. And Sheon’s AMDR presentation shows what happens when the manufacturers get a hall pass: They maximize their own profits by, in this case, doing everything they can to thwart these important environmental and financial initiatives, in spite of their ”participation” in the initiatives.

Most original manufacturers in medical technology are companies with ethics and sound, responsible business practices. The behavior Sheon discussed is not characteristic of every manufacturer of single-use devices. I had great dialogue with some manufacturers at CleanMed who pointed out that their company culture would simply not allow such behavior, and I fully believe this. However, a hall pass is a hall pass, and if the industry is not brought in and made accountable, the temptation is there, and some are going to grab it for the sake of short-sighted and one-sided profitability.

So how IS the manufacturer brought into discussions about single-use device reprocessing? How are they made to co-own the effort to maximize re-use in healthcare, to make it more sustainable? The answer is much simpler than the process of making them accountable, due to the semi-monopolistics relations they have with providers: Stop deliberately designing devices to limit reuse, and help hospitals reduce sustainability impact by having your reps support re-use programs as opposed to fighting them:

1) Original manufacturers decide to label a medical device “single-use”. The FDA doesn’t. In some cases, medical devices are simply too fragile to be used more than once. In these cases, the label truly protects the patient, the doctor, and the hospital. But when original manufacturers start launching – for example - cables used in cardiology procedures as “single-use”, it is hard to see that the reason is patient safety. These cables connect consoles with devices and drape over the patient on top of multiple layers of garments and wraps. They never even touch the patient. “Single-use” - why? To sell more? Some of these cables are more than a thousand dollars apiece, and as long as healthcare has been begging for more re-use, manufacturers have launched more, not less, “single-use” products. Manufacturers have to be made responsible for medical design processes that are focused on limiting, not enabling, reuse. We know from testimony and otherwise that some manufacturers have design committees in place to limit reuse in the product design, packaging, and distribution process. These practices should be included in discussions about single-use device reprocessing.

2) The lawsuit about limiting technical support when using reprocessed devices illustrates another issue: When medical device reps are told that the singular success criterion to judge your value is your commission statement, these same reps will do everything they can to reduce re-use. It happens every day in contracting, reprocessing counter-detailing, and when some reps sow doubt and confusion among clinicians about the safety and functionality of reprocessed devices - whose safety record over the past decades is actually better than that of the manufacturers.

I have been in the reprocessing industry for almost 2 decades, and I can tell you this without hesitation: The original manufacturer is the single most important reason why device re-use has not flourished and dramatically reduced environmental and financial burdens. As long as they are given a hall pass in work streams such as the CHARME process, we face an uphill battle.