WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 8.2-reprocessing: Do not reuse single-use devices except under NRA-permitted conditions; an entity reprocessing them becomes the manufacturer, with risk assessment, validated reprocessing, a QMS, traceability, labelling as reprocessed and incident reporting

What does 8.2-reprocessing require?

Devices labelled single-use should be used on one patient in one procedure and then discarded, and reprocessing is acceptable only where the NRA, weighing risks and benefits, permits it for specified devices (in dire situations such as a pandemic, for a limited time and after validation). An entity that reprocesses and places single-use devices on the market becomes their manufacturer, taking on all manufacturer duties (for example labelling, signing the declaration of conformity, incident reporting, post-market surveillance and responsibility for the device's safety, quality and performance) plus a risk assessment of construction, materials and design changes, validation of the reprocessing, a QMS and traceability after release; the original manufacturer is named in the technical dossier, and the label names the reprocessor and states that the device was reprocessed. A health care facility reprocessing for its own use must meet the same conditions or refrain, and one supplying others is treated as a commercial reprocessor.