Reprocessing of medical devices in off-premises clinics

This professional practice guide aims to promote good practices in the reprocessing of semi-critical and critical medical devices (RDM) in off-site clinics. It brings together scientific, clinical, normative and regulatory information relating to RDM. It is aimed at all people working in the latter with direct or indirect responsibility for RDM. It also aims to support the authorities (professional orders, public health departments (DSPu)) which may require the implementation of measures to manage health risks and protect the population.

Non-facility clinics include all health care settings that are not a facility or specialty medical center (SMC) as defined in the Act respecting health services and social services¹. They include medical clinics, family medicine groups (GMF), health professional offices, and community health care centers. This guide is intended in particular for medical directors, managers of non-establishment clinics, health professionals (e.g.: doctors, nurses, specialized nurse practitioners, physiotherapists, occupational therapists, respiratory therapists, practical nurses, podiatrists) as well as staff assigned to the RDM.

Furthermore, this guide for non-establishment clinics is not intended for establishments in the health and social services network (RSSS) (public and private) and CMS which must instead refer to the practice guide on the reprocessing of critical medical devices (INSPQ, 2014a).

This reference document

constitutes additional information to the practice guides previously published by the Center of Expertise in Reprocessing of Medical Devices (CERDM) of the National Institute of Public Health of Quebec (INSPQ)². Note that the publications developed specifically for the reprocessing of ultrasound probes and for that of ophthalmic medical devices (MD) are aimed at non-establishment clinics as well as RSSS establishments and CMS (INSPQ, 2016c, 2022). In addition, off-site clinics that use endoscopic devices must reprocess them with reference to the practice guide on reprocessing flexible endoscopic devices (INSPQ, 2014d).

This document first specifies the context and methodology for developing the guide. Then, it describes the determination of reprocessing activities, the sharing of responsibilities, the general principles, as well as the environmental and material requirements associated with reusable RDMs. It then defines the expected reprocessing steps for the MDs semi-critical and critical. Subsequently, the different elements of quality assurance are described. Finally, tools and diagrams are available in the appendix.

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¹Health Services and Services Act social. CQLR., chapter S-4.2. Current as of 1^is January 2023. Available at: https://www.legisquebec.gouv.qc.ca/fr/tdm/lc/S-4.2
²Available at: https://www.inspq.qc.ca/cerdm