Biomed 101: Hospitals Urgently Need Circular Economy Solutions, Right to Repair Medical Devices

By Daniel J. Vukelich, ESQ

Climate change is a public health threat impacting everyone. As water and air pollution increase, so do deadly chronic respiratory diseases.¹ Increased temperatures due to climate change lead to increased ground-level ozone, which cause airway inflammation and damages lung tissue.² That 5% of all greenhouse gas emissions are caused by the health sector – the institutions charged with returning us to good health – should be a call to action to all health care workers to reduce waste and lower emissions.³ 

By reprocessing single use medical devices, hospitals reduce costs, waste and emissions. They also build a more resilient supply chain by keeping devices in circulation longer, reducing the demands of the global supply chain. At a time when U.S. hospitals are expected to lose $54 billion, circular economy solutions that eliminate waste and invest in sustainability are desperately needed.⁴ Urvashi Bhatnager and Paul Anastas, authors of “The Sustainability Scorecard: How to Implement and Profit from Unexpected Solutions,” use reprocessing of medical devices as a textbook example for how to simultaneously lower costs and improve an organization’s carbon footprint. 

Similarly, the “Right to Repair” movement is enabling consumers to extend the life of other products, including mobile phones or tractors, demonstrating that circular economy solutions cross industries. Single-use device (SUD) reprocessing is highly regulated by FDA and other medical device oversight agencies across the globe, providing a safe, regulated, circular economy solution for health care. However, like with other products, some manufacturers seek to undermine consumers (or hospitals) rights to do with their products what they will, including repair and reprocessing.

The Right to Reprocess

Hospitals and surgical centers should view all medical equipment as assets that health care facilities – the consumers of these items – have a right to repair or reprocess.

The larger right to repair movement gaining attention in Congress, state legislatures and in regulatory agencies, underscores the rights consumers have to repair the products they buy, including the rights to choose service or repair providers not affiliated with the original manufacturer. When it comes to medical equipment, hospitals are just like any other consumers of products.

Electronics consumers are well aware of planned obsolescence measures some manufacturers build into mobile phones, MP3 players and earbuds. The same is true for hospitals and surgical centers who often have little option but to accept the latest model equipment from device manufacturers, which may mean accepting devices with wasteful, built-in planned obsolescence.

By viewing SUDs as assets and reminding original equipment manufacturer (OEM) partners that they must work together to overcome cost, waste and supply chain disruptions, reprocessing programs must not be hindered. However, even though use of reprocessed SUDs requires FDA or other agency clearance or approval and is a well-established practice at over 10,300 hospitals worldwide, some manufacturers are routinely seeking to infringe on this right.

Examples of Efforts that Hinder a Hospital’s Right to Reprocess SUDs

AMDR urges hospitals and surgical centers to partner with medical device makers and reprocessors that seek to maximize the value of device assets (extend their life) and therefore reduce costs, waste and emissions. Efforts that inhibit a hospital’s right to reprocessing and undermine reprocessing programs include: 

1. OEM Staff Influence: When some OEMs lend staff to the operating room, hospitals may become overly reliant on that staff and it may amount to greater costs and consumption by the hospital. AMDR is aware of some OEMs, once entrenched, who threaten to pull the staff unless the hospital agrees to stop reprocessing some SUDs. AMDR urges hospitals and surgical centers to only work with vendors supportive of reprocessing programs. 
2. Software ‘upgrades:’ Another threat to the rights of hospitals to reprocess SUDs is some OEM use of software “updates” or “upgrades” that prevent reprocessed versions of these devices from working with consoles or generators. By manufacturing the devices with microchips and updating the software on the generators, some OEMs are causing more waste, cutting out competition, and increasing a hospital’s reliance on the OEM by preventing reprocessed versions of medical devices from working. AMDR urges hospitals and surgical centers to work with vendors that do NOT restrict the facility’s ability to reprocess and strongly counter such measures (such as refusing software “updates”) when they encounter them as antithetical to the interests of the health institution. 
3. Forced obsolescence: The use of “erasable programmable read-only memory” (EPROM) microchips in the handles of surgical and diagnostic medical devices are being used to intentionally make it difficult to use the device more than once. Employed based on unsupported “patient safety” claims, these chips are inserted to shut the device off after a single use. AMDR has evidence that an OEM with its own reprocessing division (not an AMDR member), includes such chips, not just to discourage reprocessing, but to discourage reprocessing with competing vendors. 

Further, billed as “innovation,” some medical device manufacturers introduce new models of existing technology that are designed to make it impossible to reprocesses and reuse them. When such generational innovation disallows reprocessing, the hospital loses the savings and environmental benefits due to the OEM’s locking out reprocessing.

While many technology innovations come with clinical and technological advantages to prior models, the launch of devices with reprocessing “kill switches” or “locks” – without scientifically backed clinical advantages – is becoming more and more common. AMDR encourages hospitals and surgical centers to inform these companies they wish such activity to stop, to resist new makes and new models with such “kill chips,” and to reward with your business companies that support reprocessing.   

More information, including a resource page that further addresses each of these topics, is available at www.AMDR.org.

References

1. Amato G, Cecchi L, Amato M, et al., “Climate change and respiratory diseases,” European Respiratory Review, 2014; 23(132):161-69.
2. Amato G, Cagani Ca, Cecchi L, et al., “Climate change, air pollution, and extreme events leading to increasing prevalence of allergic respiratory diseases,” Multidisciplinary Respiratory Medicine, 2013:12.
3. Health Care Climate Footprint Report, Health Care Without Harm, September 2019
4. “Financial Effects of COVID-19: Hospital Outlook for the Remainder of 2021,” Kaufman, Hall and Associates, p.3, 2021