- the transition from glass and metal to specialist materials including plastics and composites
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the emergence of new technologies
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new manufacturing processes
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miniaturisation and increasing device complexity
Throughout the 80s and 90s, new business models, built around single use only products emerged. Fuelled by the risk of patient cross contamination (eg from sterilisation-resistant prions responsible for variant CJD), health professionals welcomed SUDs because they were guaranteed 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.
W hile a lack of real market data precludes an accurate assessment of the savings, it is claimed that reprocessed medical devices are 50 per cent cheaper than new devices**, and there are estimates that a typical 600 bed hospital could save $1 million per year* by reprocessing SUDs.
The range of SUDs that can be and are reprocessed is extensive, ranging from biopsy forceps and catheters to orthodontic braces and laparoscopy scissors. Apart from satisfying the broader environmental move towards recycling and reuse wherever possible, the reprocessing of these devices also reduces medical waste, which is five to 10 times more costly to dispose of than solid waste***. While there has been no comprehensive study that balances quantitatively all the environmental implications of reprocessing SUDs rather than discarding them, there is plenty of evidence to suggest that the strain on US landfills and incineration plants has lessened as a result of the switch to reprocessing.
One hospital system has claimed that reprocessing will reduce 13 per cent of its medical waste and save them 11 per cent on medical waste costs***.
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. 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 elsewhere. Even amongst member states of the EU, there is a divergence of position. In the UK, for example, reprocessing is strongly discouraged. In its 2006 report**** the Government’s Medicines and Healthcare Regulatory Agency (MHRA) is unequivocal and 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, while 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***** acknowledges that while the highest risk to patient health occurs when a reprocessed SUD is used for invasive medical procedures, there is actually very little hard clinical evidence to demonstrate the size of the risk.
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 own device reprocessing.
Sagentia not only offers a full technology innovation and product development service, but conducts market impact studies with OEMs on specific areas of the SUD market to characterise and quantify where the specific threats lie and predict future technology developments.
This market understanding can then be used to inform our downstream development process.
Reprocessing is here to stay. However we believe that 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.
* The Medical Device Reprocessing Industry: Increasing Hospital Sustainability, GlobalData, Sept 2009
** 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
***Hospitals rev up recycling efforts, The Detroit News, Oct 2010
****Single-use Medical Devices: Implications and consequences of Reuse, MRHA, Oct 2006
***** Report on the issue of the reprocessing of medical devices in the European Union, in accordance with Article 12a of Directive 93/42/EEC, published 28 August 2010.