The Rise of Commercial Aviation: Building Trust through Regulation
When commercial air travel first became popular, many people were sceptical about flying. In an effort to mitigate risks and build a solid reputation for the industry, 57 commercial airlines formed the International Air Transport Association (IATA) in 1945, voluntarily agreeing to accept regulations and prioritise customer safety. Since then, general scepticism towards the industry has subsided, and aviation has ultimately proven to be extremely safe.
Ethics and Self-Regulation in Medical Device Reprocessing
Today, the medical device reprocessing industry has adopted a similar—and equally welcome—culture of ethics and self-regulation among its most reputable companies. The member companies of the Association of Medical Device Reprocessors (AMDR), including Vanguard AG, are leading the way in this regard, dedicating themselves to research, advocacy, and a strict code of ethics that ensures the highest standards of quality, safety, and service.
The AMDR Seal of Membership: What Does it Mean?
If you visit the websites of AMDR member companies, you’ll likely notice the following membership seal. But what does it mean?
All members are committed to adhering to the AMDR Code of Conduct. This mandatory code requires strict compliance with all laws and regulations of the U.S. Food and Drug Administration (FDA), the European Medical Device Regulation (MDR), and any other applicable requirements in the country where the reprocessed product is marketed. Transparency in business dealings and respect for competition are considered fundamental principles. Members must act in the best interests of healthcare providers, patients, and the planet by delivering more cost-effective, lower-emission, and waste-reducing healthcare products.
Setting High Ethical Standards in Medical Device Reprocessing
In short, a framework is in place that binds some of the largest players in this industry to the highest ethical standards. Not all reprocessors adhere to such standards. They don’t necessarily need to abide by the Hippocratic Oath, but AMDR members must follow the shared Code of Conduct.
Industry Leaders in Research and Sustainability
Vanguard AG, Stryker Sustainability Solutions, and Cardinal Sustainable Technologies are at the forefront of research, demonstrating the environmental and economic benefits of reprocessing. Innovative Health fights for fairness for all reprocessors by legally challenging anti-competitive, reprocessing-hostile practices from certain original equipment manufacturers (OEMs). Medline continues to grow and expand its activities, removing more and more devices from the waste stream and creating thousands of green jobs in the process.
Beyond Profit: Environmental and Social Responsibility
In summary, AMDR members go beyond their primary mission to succeed as companies. Their motivation goes beyond pure profit: they are environmental and social stewards who, driven by a shared desire for a cleaner, greener supply chain, welcome regulation, oversight, and honesty within our industry. Healthcare should not make us sicker.
Irrational Fears and Their Consequences
After the events of 11 September 2001, many travellers, fearful of flying, opted to drive instead. As a result of the increased road traffic, the number of road deaths rose dramatically, possibly leading to as many as 2,300 additional fatalities. Driven by irrational fear, people chose a more dangerous course of action, with catastrophic (though unintended) consequences.
Overcoming Irrational Fears in Medical Device Reprocessing
Irrational fears of this kind are also evident in healthcare. It has been shown that the perception of risk to patient safety is one of the main barriers to the adoption of reprocessed products by healthcare providers, along with the negative stance of some OEMs towards the reprocessing of single-use medical devices. This is despite more than two decades of research showing no convincing evidence that reprocessed products are any more dangerous than their newly manufactured counterparts.
The Impact of Healthcare on the Environment
At the same time, healthcare’s greenhouse gas emissions and air pollution are harming the health of both people and the planet. The industry is responsible for around 5% of global carbon emissions—more than the aviation industry. Since the vast majority of this pollution comes from healthcare supply chains, it logically follows that medical remanufacturing and reprocessing should be considered.
The Environmental and Economic Benefits of Reprocessing
Thanks to a growing body of research, lifecycle analyses, and a decades-long track record demonstrating that reprocessing drastically reduces costs, waste, and carbon emissions in healthcare without compromising patient safety, these irrational fears can be overcome.
Growing Support for Reprocessing in Healthcare
More and more providers are signalling their desire to use reprocessed products. Increasingly, journalists are writing positively about reprocessing. At recent conferences like CleanMed 2024 and the Medtech Sustainability Forum, more and more providers, researchers, and other healthcare stakeholders have voiced their support for medical remanufacturing and reprocessing.
AMDR’s Role in Shaping the Future of Medical Device Reprocessing
And all this is made possible by the integrity and professionalism of AMDR and its member companies. Like the airlines of the 1940s and 50s, we have earned the trust of our customers through an open and unabashed enthusiasm for regulation and transparency. We call on all reprocessing companies to join our members and adopt this mindset. Together, we will earn a reputation so unassailable that well-regulated medical device reprocessing and medical remanufacturing will become the standard treatment at the end of the lifecycle for all medical devices in the United States, Europe, and beyond.
