As their name implies, single-use devices (SUDs) are made for a one-time application but according to the UK’s regulatory authority MHRA, some companies – ‘re-manufacturers’ – are decontaminating, cleaning and sterilising such products and placing them back on the market.
As such, the agency has called upon healthcare professionals, manufacturers and providers of medical devices to comment on new guidance which would help ensure the safety of re-manufactured devices.
“Anyone who re-manufactures a single-use device has the same legal responsibility for it as the original manufacturer,” the guidelines state.
Furthermore, while SUDs can be re-manufactured in the UK, a company must meet all relevant criteria under the appropriate Medical Devices Directive, place a CE-mark on their product, and add a symbol – the figure ‘2’ in a circle with a line through it – on the packaging .
“There is currently no UK guidance related to re-manufacturing of single-use,” MHRA spokesman Nick Spears told this publication, adding that guidance is already available in a number of other EU countries, the US and Australia on this issue.
“The guidance is proposing a UK position on re-manufacturing of single-use devices, thus the target audience for is primarily UK Notified Bodies, and manufacturers who put their products on the UK market.”
One point the guidelines makes clear is that there is a difference between re-manufacturing and re-processing, the former being done by a company – usually the original device manufacturer – that must demonstrate validity and surety of all the manufacturing processes.
Reprocessing SUDs is where a person or organisation, cleans and sterilises the medical device and it goes back into the healthcare environment - contrary to the manufacturer’s instructions, and with all the markings of the original device – and is not advised by the MHRA.