Devicemakers in the UK that remanufacture single-use devices must accept all the obligations and liabilities that an original manufacturer would face, the regulator said.
The UK’s Medicines & Healthcare products Regulatory Agency issued its first formal guidance on remanufacturing single-use devices; however, it notes that the medical device directives “do not explicitly permit remanufacturing or reprocessing.”
Although single-use devices may be manufactured in the UK, the remanufacturer must ensure that the intended use of the device is the same as the original product.
Class I medical devices are excluded from this policy, however, because there would be no external or independent assessment of CE mark compliance.
The guidance also notes that supply of a remanufactured single-use device (SUD) should be through a closed-loop contract between the remanufacturer and the healthcare provider. “At no time should a remanufacturer or healthcare institution sell or provide a remanufactured SUD to any other third party,” it clarifies.
Notified bodies should verify that remanufactured devices meet all the appropriate criteria in terms of performance and safety and should confirm “validity and surety of all manufacturing processes.”
The remanufacturer also must determine via clinical and technical testing the maximum number of remanufacturing cycles which the device should be subjected to. It also must track the number of times the device is remanufactured and used.
The guidance also lists requirements for decontamination, cleaning, sterilization, labeling, risk management and postmarket surveillance activities.
Labeling and packaging must include a symbol indicating that the product is a single-use device to be used only once. The remanufacturer also should identify itself on the label with a serial number and unique identifier to ensure traceability.
Read the guidance here: www.fdanews.com/07-14-16-UKsingle-usedevices.pdf. — Tamra Sami