The reprocessing and reuse of SUDs is generating divisive debate between device OEMs, approval authorities, hospitals and the reprocessing industry. The range of SUDs that can be and are reprocessed is extensive, ranging from biopsy forceps and catheters to orthodontic braces and laparoscopy scissors. Despite strong views for and against, the combination of environmental concerns and cost pressures on healthcare provision means that OEMs need to be prepared for increasing adoption of reprocessing.

A recent GlobalData industry report[1] supports this view, predicting a seven to 10% annual growth rate over five years. This would take the 2008 global medical device reprocessing market value of $520m (£320m) to just under $1bn (£620m) by 2015.

Challenges and opportunities for OEMs

SUD reprocessing presents a serious long term threat to OEM revenue streams. However, a swift and strategic response to the threat stands to unearth a range of counter measures that OEMs can deploy to retain control over their products. This involves a reappraisal of existing business models and a serious look at how best to deploy technology innovation to protect revenue and ensure the long term value of their brand.

For instance, taking existing products and brainstorming around modifications, enhancements and cost challenges could throw up many opportunities. This could include ways to prevent devices from being reprocessed; splitting them out into reusable and disposable elements; or making them more suited to reprocessing. The incorporation of electronics to monitor or prevent reuse and the use of novel materials are two additional areas that could be explored.

Changing landscape for SUDs

The reuse of medical devices was once universal. However, effective cleaning and sterilisation procedures have become increasingly challenging as a result of a number of trends, including:

  • the transition from glass and metal to specialist materials including plastics and composites
  • the emergence of new technologies
  • the introduction of new manufacturing processes
  • the miniaturisation and increasing complexity of devices.

Throughout the 1980s and 90s, new business models built around single use only products emerged. Fuelled by the risk of patient cross contamination (e.g. from sterilisation-resistant prions responsible for variant CJD), health professionals welcomed SUDs because they were guaranteed to be free from contamination.

Today, the clinical, financial, legal and environmental landscape for SUDs is dramatically different. Off the back of a relentless pressure on hospitals to reduce cost and waste, a new market has emerged to legitimately reprocess these devices.

While a lack of real market data precludes an accurate assessment of the savings, it is claimed that reprocessed medical devices are 50% cheaper than new devices[2], and there are estimates that a typical 600 bed hospital could save over $1m (£620,000) per year[3] by reprocessing SUDs.

In a 2011 study[4], researchers at The Johns Hopkins University School of Medicine suggest that the reprocessing of SUDs can be an effective way to help reduce waste and improve hospitals’ carbon footprints. The JHU study identifies that over 6,600 tons of waste are generated every day from US healthcare facilities. Evidence suggests that the strain on landfills and incineration plants can be lessened as a result of the switch to reprocessing. For instance, one US hospital system claimed that reprocessing would reduce its medical waste by 13% and save them 11% on medical waste costs[5]. Given medical waste is five to ten times more costly to dispose of than solid waste[6], such savings are not unsurprising.

The complete environmental picture is not as clear since there has been no comprehensive study that balances quantitatively all the environmental implications of reprocessing SUDs rather than discarding them. There are calls, particularly from the EU[7], for such a comprehensive environmental impact assessment to be done. This could weigh the benefits of reprocessing against increased transport and energy consumption and effect of using chemical disinfectants in the overall process.

Regulatory differences

The one single point that everyone is in agreement with is that patient safety is paramount. But attitudes vary considerably from country to country. In the US, the FDA has adopted what many believe to be a pragmatic attitude and has not stood in the way of reprocessing. It takes the view that ‘appropriate’ regulation is the way forward, clearly stating that legal responsibility for safety of the reprocessed device lies entirely with the reprocessor.

Among a range of regulatory hurdles set by the FDA is the requirement that reprocessors submit extensive written proof that their methods of cleaning, sterilisation, validation, performance testing and packing will produce a safe and effective SUD.

The FDA’s approach is not replicated everywhere. Within the EU, in the absence of specific harmonised regulation, the practice is currently left to guidance and legislation at the national level, resulting in a regional variation. In the UK, for example, reprocessing is strongly discouraged. In its 2006 report[8], the Government’s Medicines and Healthcare Regulatory Agency (MHRA) unequivocally states ‘A device designated for ‘single use’ must not be reused’ and warns of the legal implications if it is. In France the practice is currently banned outright, whereas in Germany and a number of other states reprocessing is allowed under guidelines.

Set against this significant variation in approach, a recent European Commission report[9] acknowledges that although the number of documented patient incidents arising as a result of reprocessing is small, the Commission needs to do a thorough assessment of the potential economic, social and environmental consequences that a unified EU measure on reprocessing would have. Until this happens, the burden of proof will remain with those pressing for greater adoption. They could collate data from the US to support their claims, but it may yet be some time before a real consensus develops.

The uncertain road forward that can bring opportunity

Faced with crippling healthcare costs, significant environmental concerns and a fast growing reprocessing sector, the SUD market dynamic is set for change. While initially this would appear to be gloomy news for OEMs, a proactive response can protect products, brand and revenue stream.

Business strategy and analysis work can be used to take a deep look at existing business models and make recommendations on how best to respond to a changing market. Combining this work with technical innovation may, for example, lead to adapted device pricing structures, device modification, a switch from single use to reuse or even the prospect of an OEM entering the reprocessing market and managing the complete device reprocessing themselves.

All points considered, what is clear is that reprocessing is here to stay. Companies who acknowledge this early on and respond to the issues it raises can turn this trend to their advantage, securing brand integrity whilst working with the industry to improve efficiencies.


by Alistair Fleming, Senior Consultant, Sagentia


  1. The Medical Device Reprocessing Industry: Increasing Hospital Sustainability, GlobalData, Sept 2009
  2. Commentary: A Call to Go Green in Health Care by Reprocessing Medical Equipment Kwakye, Gifty MPH; Pronovost, Peter J. MD, PhD; Makary,Martin A. MD, MPH; Academic Medicine: March 2010 – Volume 85 – Issue 3 – pp 398-400
  3. The Medical Device Reprocessing Industry: Increasing Hospital Sustainability, GlobalData, Sept 2009
  4. Green Surgical Practices for Health Care: Gifty Kwakye, MD, MPH; Gabriel A. Brat, MD, MPH; Martin A. Makary, MD, MPH Arch Surg. 2011;146(2):131-136
  5. Hospitals rev up recycling efforts, The Detroit News, Oct 2010
  6. Hospitals rev up recycling efforts, The Detroit News, Oct 2010
  7. Report from the Commission to the European Parliament and the Council: Report on the issue of the reprocessing of medical devices in the European Union, Brussels, 27.8.2010
  8. Single-use Medical Devices: Implications and consequences of Reuse, MRHA, Oct 2006
  9. Report from the Commission to the European Parliament and the Council: Report on the issue of the reprocessing of medical devices in the European Union, Brussels, 27.8.2010