MHRA Wants Input on Single-Use Device Re-Manufacture Guidance
The Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a survey to gather input on its new draft guidance on the re-manufacturing of single-use devices.
Note: at the time of publishing, the survey appears to be closed. According to MHRA's announcement the survey should be available until 1 September 2015.
Background
In the past, medical devices were typically designed to be reusable and were built to withstand cleaning procedures such as steam sterilization.
That changed in the 1980s, when increased awareness of blood-borne diseases such as hepatitis and HIV pushed device manufacturers to develop single-use products intended to minimize the risk of viral transmission. These products were often constructed using cheaper materials that were not meant to withstand sterilization processes.
New technologies also allowed for medical devices with smaller, more complex components that were more difficult to clean or sterilize.
Single-use and reusable devices are also defined in Directive 93/42/EEC, which states that devices intended for single-use must be marked as such. Single-use devices were then further clarified in Directive 2007/47/EC, which adds the clarification that single-use devices are "intended to be used once only for a single patient."
In recent years, members of industry and regulators have requested additional clarification from the European Commission (EC) regarding single-use devices, which released a report on the subject in 2010.
The report raised several concerns about the safety and liability of reprocessed single-use devices, including "remaining contamination, the persistence of chemical substances used during the reprocessing process and the alterations in performance of the … device due to the reprocessing."
Reprocessing vs Re-manufacturing
Presently, reprocessing single-use devices is not regulated at the EU level. Some individual countries, such as Germany, allow single-use devices to be reprocessed using the same standards that apply to reusable devices. Others countries, such as France, do not allow the practice, and many "do not have any specific regulations" on the subject.
The UK currently does not allow reprocessing of single-use devices; however, MHRA says that it has been approached by multiple manufacturers who "re-manufacture" and CE mark used single-use devices.
For the past two years, MHRA says it has been investigating re-manufacturers and "assessing their technical, regulatory and clinical processes." Following its review, MHRA said it sees a distinction between re-manufactured and reprocessed single-use devices.
In its draft guidance, MHRA says re-manufactured single-use devices must conform to the relevant medical device directive(s), acquire a CE mark, and satisfy the requirements of a notified body assessing the product.
MHRA also says that Class I devices should not be re-manufactured as "there would be no external or independent assessment of CE-mark compliance." When a device is re-manufactured multiple times, it should always be done by the same company. Remanufacturers must also validate the number of times a device can be re-manufactured before it must be disposed of.
Additionally, re-manufactured devices should retain all markings by the original manufacturer, as well as new markings by the re-manufacturer, including company name, address and serial number, and the "packaging and instructions for use must clearly state that this product has been re-manufactured from the original."
The guidance also clarifies that the original manufacturer is not responsible for remanufactured products, and the re-manufacturer is responsible for post-market surveillance of any re-manufactured single-use device.
New EU Medical Device Legislation
MHRA also acknowledges that its guidance may need to be updated to reflect changes at the EU level related to single-use devices if new medical device legislation is adopted.
Single-use device reprocessing is addressed in the most recent draft proposals by the European Council, Parliament and Commission for changes to EU medical device regulation. In the council's proposal, single-use devices may be reprocessed "where permitted by national law."
The proposal would consider reprocessors to be the manufacturer of a device, taking on all responsibilities of the original device maker, and require reprocessors to ensure that reprocessed devices are equivalent to the original device in terms of safety and specification. The proposal would require the EC to establish a list of device categories that are not suitable for reprocessing.
It is important to note that the council proposal leaves it up to the Member States to "maintain or introduce stricter national provisions restricting or prohibiting … the reprocessing of single-use devices."