UK regulatory authority MHRA (Medicines and Healthcare Products Regulatory Agency) has introduced a survey to collect input on its new draft guidance on the re-production of single-use devices (SUDs).
Previously, medical devices were commonly developed to be reusable and were developed to withstand cleaning processes like as steam sterilization.
That transformed in the 1980s, when enhanced understanding of blood-borne health problems like hepatitis and HIV forced device companies to develop single-use products designed to reduce the risk of viral transmission. These goods were usually produced using cheaper materials that were not designed to withstand sterilization processes.
New technology also allowed for medical devices with smaller, more complex components that were more challenging to clean or sterilize.
Single-use and multiple-use devices are also described in Directive 93/42/EEC, which declares that devices designed for single-use should be marked as such. SUDs were then even more clarified in Directive 2007/47/EC, which offers the outline that SUDs are “designed to be used once only for a single individual.”
In recent times, members of regulators authorities and industry have requested further clarification from the European Commission (EC) about single-use devices, which published a report on the subject in 2010.
The report pointed out various issues about the safety and liability of reprocessed single-use devices, such as “leftover contamination, the perseverance of chemical compounds utilized while in the reprocessing process and the variations in efficiency of the device because of the reprocessing.”
Reprocessing vs Re-manufacturing
Currently, reprocessing SUDs is not regulated at the EU level. Some individual nations, for example Germany, allow SUDs to be reprocessed applying the same standards that utilize to multiple-use devices. Others nations, for example France, do not enable the practice, and many nations do not have any particular guidelines on the subject.
The UK at this time does not allow reprocessing of SUDs; on the other hand, MHRA states that it has been contacted by multiple companies who “re-manufacture” and CE mark used SUDs.
MHRA states that over the last two years, it has been analyzing re-manufacturers and evaluating their technical, regulatory and clinical processes. Following its assessment, MHRA stated it observes a difference between re-produced and reprocessed single-use devices.
In its draft guidance, MHRA states that re-produced SUDs should conform to the related medical device directive(s), obtain a CE mark, and fulfill the specifications of a notified body evaluating the product.
MHRA also states that that Class I devices shouldn’t be re-produced as “there would be no outside or independent evaluation of CE-mark compliance.” When a medical device is reproduced numerous times, it should usually be done by the same firm. Reproducers must also confirm the number of times a device can be re-produced before it must be disposed of.
In addition, re-manufactured devices must retain all markings by the initial manufacturer, along with new markings by the re-producer, such as company name, address and serial number, and the product packaging and recommendations for use should clearly suggest that this product has been re-produced from the original.”
The draft guidance also points out that the initial manufacturer is not accountable for reproduced products, and the re-producer is accountable for Phase IV study of any re-produced single-use device.
New EU Medical Device Guidlines
MHRA also understands that its guidance may have to be updated to reflect modifications at the EU level relevant to SUDs if new medical devices guidelines are adopted.
SUDs reprocessing is addressed in the very latest draft proposals by the EU, Parliament and Commission for modifications to EU medical device legislation. In the council’s proposal, SUDs may be reprocessed “where permitted by country’s law.”
The proposal would think about re-processors to be the manufacturer of a device, taking on all duties of the initial device maker, and need re-processors to make sure that reprocessed devices are equal to the original device with regards to safety and standards. The proposal would require the EC to create a list of device classes that are not appropriate for reprocessing.
It is essential to note that the council proposal leaves it up to the Member States to “continue or set up tighter country’s provisions limiting or prohibiting the reprocessing of single-use devices.”