During the financial downturn, hospitals and clinics have become increasingly reliant on concepts such as medical device reprocessing for increasing sustainability. According to a report by Global Data, ‘The Medical Device Reprocessing Industry: Increasing Hospital Sustainability‘, it is easy to understand why – reprocessing medical devices not only cuts costs but helps reduce waste volumes as well. Some hospitals and clinics that have adopted the idea have even saved as much as half of their spending on single-use devices (SUDs).
The concept of medical device reprocessing is not new. It first became widespread in the late 1970s when traditional reprocessing became a proprietary function within hospitals, which used sterilisation to make medical devices suitable for reuse.
As hygiene standards increased, the concept became increasingly hybrid and today involves professional third-party reprocessing service providers that have effectively commercialised medical device reuse. This new era in reprocessing has given way to a bitter battle between original equipment manufacturers (OEMs) and the new reprocessing industry.
The reprocessing industry has emerged triumphantly and is now estimated to be worth over $500m in revenues. It is also expected to witness a healthy growth rate in the future and could prove to be a major restraint for SUD manufacturers.
A potential stumbling block, however, is the issue of safety and regulation, which must work in conjunction with the OEMs.
The new face of reprocessing
The reprocessing medical device industry is no longer constrained to the reprocessing of used medical devices. It now also includes reprocessing of products with expired shelf lives and unused products that have not been used in a procedure but are opened.
Such developments are largely due to technological advancements. Before the shift of medical devices towards SUDs, devices were made of materials like glass, rubber or metal.
The advances in technology over the last two decades, however, have introduced materials such as plastic and fibre with complex mechanisms. These devices were labelled as SUDs since it was difficult to sterilise them. With the economy facing slumps and surges over the last decade, hospitals and clinics found it increasingly important to control costs leading to the resurgence of the reprocessing industry.
Recycling single-use products became more attractive as devices became more complex; prices rose and advanced sterilisation techniques allowed a larger range of products to be sterilised. The reprocessing industry effectively helped control costs and increase profit margins for private clinics.
Cardiac catheters, for example, cost a considerable amount for a single patient, but hospitals could cut the cost almost in half by using it on two patients. Studies have even shown that with 100% compliance rate, a 600-bed hospital could save over a million dollars annually.
The reprocessing roadblocks
While the reprocessing industry can help control costs and increase profits, at the same time it raises vital questions of patient safety. An OEM requires a pre-market approval to change its labelling, but at the moment there are no legislations in place for the monitoring of reprocessed devices. This and questions on the ethicality of using SUDs for a second time keep rising to prominence.
This has led the US regulatory system to take action against the model of reprocessing. They are now subject to risk-based pre- and post-market review that includes validation of the reprocessor’s sterilisation process.
Increasing pressure from lobby groups questioning the safety of reprocessing and OEMs has moved the FDA to start placing norms on the reprocessing industry.
This stringent regulation towards the reprocessing industry by the US Food and Drug Administration (FDA) has positively impacted the reprocessing industry. Healthcare providers and patients alike feel safer with the FDA monitoring and maintaining good reprocessing practices.
The future, however, appears bleak. Future legislations, making the process stricter, are expected to raise the costs of reprocessing. This narrowing of price between new and used devices could shift user trend towards new devices.
The situation fares worse in Europe, where some member countries are already either banning reprocessing or allowing it only under strict supervision. Experts believe the EU desperately needs to streamline the exact norms that define reprocessing.
The future face of the market
In spite of these uncertainties, the economic recession has played its part in boosting the reprocessing industry. Dwindling cash reserves have pushed hospitals and clinics towards tightening hospital spending. In the US, it has now become the norm for hospitals to reprocess SUDs – with some level of processing now being undertaken in 70% of hospitals nationwide.
Over 3,000 hospitals in the US now have an in-house or outsourced reprocessing programme. Industry experts believe that devices such as external fixators can offer large savings, which in some cases can amount to over $150,000 annually. Its influence is particularly prevalent in the operating room – saving up to $100,000 for a 100-bed hospital through the reprocessing of laparoscopic trocars, ultrasonic scalpels and multi-clip appliers. Additionally, electrophysiology labs are
estimated to save up to $150,000 annually through reprocessing of EP and imaging catheters.
With the industry forecast to be worth nearly $1bn by the year 2015, the market is expected to produce many more opportunities in the future. Reprocessing has certainly helped increase the sustainability quotient of hospitals hit by the economic recession and will inevitably continue to do so.
The trend of considering reprocessing as an ecological benefit will undoubtedly appeal to the developed nations. With over 10% of medical devices belonging to the SUD class and over 250 types of devices being reprocessed, the reprocessing market will continue to grow with a healthy level of 9% for the next four years.
Issues relating to stricter regulatory norms and ethical dilemmas will, however, continue to plague the reprocessing industry.
Reprocessing firms need to address these issues proactively and conducting an unbiased study determining the safety of reused or reprocessed devices maybe one such way forward.