Why single-use devices?
In the not too distant past medical devices were re-usable. Their design, shape, size and materials used (glass, metal and rubber) were easy to clean and sterilise. However, as public awareness of HIV and later vCJD the need for single-use medical devices to reduce the risk of infection became established.
Single-use devices don't have to withstand the rigours of reprocessing and allow the use of different materials and more complex designs. Many of these devices are more challenging to clean or sterilise and are labelled for ‘single-use’.
What are the regulations regarding medical devices?
In the European Union, medical devices are regulated by the Medical Devices Directives (MDDs). This legislation came into existence in the 90's to harmonise and regulate the standards of safety, quality and efficiency of medical devices for sale in the European market.
In 1993, the European Union’s Medical Devices Directive made a clear distinction between those medical devices which were intended by the manufacturer to be reused and those intended only for single-use. In the case of reusable devices, this meant including instructions on how to prepare for re-use and any restrictions on the number of times it may be recycled. Those devices intended for single-use needed to have this clearly indicated on the label.
Are we allowed to re-process single-use devices?
At the moment, there is no EU-wide law to prevent or sanction reprocessing of single-use devices; each country has its own regulations. In France, the re-use of single-use devices is illegal; in the UK, health authorities have issued guidance which warns of the potential risks and consequences when re-using a single-use device. Meanwhile, Germany has guidelines in place to regulate reprocessing to a certain extent, although it makes no legal distinction between single-use and multiple-use devices.
In the USA, the government and FDA has enacted legislation that allows the reprocessing of single-use medical devices. These laws include the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and Medical Device User Fee Stabilization Act of 2005 (MDUFSA). On the back of this an industry has grown up to refurbish, repackage and re-use single use devices.
What do you think? Should the EU allow single-use medical devices be re-processed and re-used?
I think that reprocessing should be allowed - any regulations should relate to the quality of the instruments to be used rather than how they got there. However, I'm not quite clear what is involved in reprocessing: do compound materials and complex designs mean that instruments are essentially being disassembled and their parts recycled? Over time, if reprocessing becomes standard, then ideally this would lead to design modifications to make the process more efficient.
I'd also be interested to know whether the environmental impact is considered during reprocessing - does anybody know? Presumably there are all the same opportunities to save energy, water etc as in manufacturing new equipment.
Finally, the "need" for single-use medical devices to reduce the risk of infection... is open for debate! See http://sustainablehealthcare.org.uk/sustainable-operating-theatres/blog…
Frances
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