Cost, safety, and environmental impact of reprocessing single-use medical devices. A systematic review and meta-analysis

Since May 2021, European Union member states were required to adopt a legislative stance on single use medical device (SUD) reprocessing i.e. a process including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device. The main objective of this review was to determine the financial costs, and the safety and environmental consequences, of reusing reprocessed SUDs in line with the 2017 EU MDR and other related approaches. The review forms part of a wide, targeted consultation by the Department of Health to gather feedback on the stance adopted in Ireland i.e the most heavily regulated option permitting reprocessing.

The study protocol was registered (PROSPERO ID: CRD42022365642). Included studies were separated into two groups: in vitro (i.e. studies examining reprocessing in a laboratory) and in vivo (i.e. studies examining reprocessing during clinical care). Only in vivo studies went through all phases of the standard systematic review process. All findings were reported by device risk class: risk class I (little risk); risk class IIa (unlikely risk); risk class IIb (potential risk of deterioration); and risk class III (risk of death).

Of 23 SUDs identified, external fixator devices and implantable cardiac devices reported no additional adverse events after one reprocessing cycle. Reprocessing resulted in cost savings but marginal savings diminished with subsequent reprocessing cycles. Depending on the SUD, reprocessing reduces global warming impacts but may exacerbate human health impacts. Reviewers had little confidence in the effects reported across all outcome types.