Preface 

This is the second edition of CSA Z314, Canadian medical device reprocessing in all health care settings . It supersedes the previous edition published in 2018 under the title Canadian medical device reprocessing. This Standard addresses the safe and effective reprocessing of medical devices and supplies. Changes to this edition include the following: a) Revised the Scope (Clause 1) to extend coverage of heath care settings to include professional offices, independent doctors’ offices, community health care centres, private practices, and additional health care settings as applicable, as well as exclusion of sterilization by injecting ethylene oxide (EO) or mixtures containing EO directly into packages or a flexible chamber. b) Revised the general requirements (Clause 4) for minimum level of reprocessing for semi-critical medical devices and handling of reusable medical devices, including risk assessment. c) Updated requirements for quality management systems (Clause 5), including key performance indicators, water quality, as well as leadership, planning, provision of resources, and operation improvements. d) Updated requirements for personnel (Clause 6) covering competency training and continuing education, including occupational health and safety and infection prevention and control training. e) Updated requirements for manufacturer’s instructions for use (Clause 7), covering new technologies, evaluation, and purchase of reusable medical devices, as well as reprocessing of sterile barrier systems and consumables. f) New and expanded requirements for evaluation and purchase of reusable medical devices (Clause 8). g) New and expanded requirements for loaned reusable medical devices (Clause 9), including modifications and alterations, licensing requirements, documentation and records, as well as safe handling and transportation. h) Updated requirements for work areas and design (Clause 10), covering hand hygiene facilities, decontamination sinks, eyewash stations and deluge showers, and clean and sterile storage area, including shelving and environmental controls. i) New and expanded requirements for decontamination of reusable medical devices (Clause 11), covering handling (point of use cleaning, sorting, sharps, and fluid management), retrieval and transport to the decontamination area, sorting and disassembly, preparation, cleaning, rinsing and drying, decontamination after manual cleaning, and disinfection of semi-critical medical devices, including requirements for liquid chemical disinfection and respiratory devices. j) New and expanded requirements for flexible endoscopes (Clause 12), including point of use cleaning, reprocessing, transportation, leak testing, cleaning and rinsing, disinfection of sinks manual high-level disinfection, automated repossessing, storage sterilization, as well as special requirements for endoscopic accessory devices, damaged endoscopes, etc. k) New and expanded requirements for ultrasound transducer probes (Clause 13), including reprocessing area, traceability, point of use cleaning, transportation, electric leak testing manual cleaning, rinsing, inspection including requirements for ultrasound probe sterilization, automated reprocess drying and storage preventative maintenance, and record keeping l) New and expanded requirements for preparation of medical devices for reprocessing (Clause 14), covering modifications and alterations, requirements for medical devices with lumens, instrument care and handling, verification of cleanliness and functionality, and lubrication, including additional requirements for basin sets, textile packs and trays, and low-temperature sterilization methods. m) New and expanded requirements for selection and use of sterile barrier systems (Clause 15), covering evaluation, purchase and inspection, packaging systems, qualifications, product design, assembly, labelling, pouches, wrappers, and rigid sterilization containers systems. n) New and expanded requirements for sterilization methods (Clause 16), covering preferred methods, critical and semi-critical medical devices, sterilizer loading, operation and unloading, liquid chemical, steam sterilizers and ethylene oxide aeration, storage of chemical sterilant and supplies, sterility assurance, routine monitoring, immediate-use steam sterilization, and table-top sterilizers. o) New and expanded requirements for storage transportation and distribution of single use and reusable medical devices (Clause 17), including general requirements (SOP, storage, shipping containers, cardboard boxes, and window and door access storage), physical and functional storage requirements, traffic and environmental conditions, equipment, water controls, Tier 3 storage area, case carts, and emergencies. p) New and expanded requirements for table-top sterilizers (Clause 18), including submicron water filter maintenance, repair or refurbishing of reusable medical devices, and utilities (steam generation, feed water, and piping networks). q) New and expanded requirements for selection of gowns and drapes (Clause 19), covering evaluation and purchase (barrier classification flammability and biocompatibility), selection (including surgical gowns, isolation gowns, and surgical drapes), and containment and handling of soiled gowns at the point of use. r) New clause and expanded requirements for environmental cleaning (Clause 20), covering general requirements, SOPs, dress code, OHS, personnel, cleaning (including cleaning of MDRA, equipment), transportation vehicles and cart covers, and cleaning of laundry areas. s) New and expanded requirements for laundering, preparation of reusable gowns, drapes, and wrappers (Clause 21), covering SOPs, purchasing decisions, personnel, work areas and equipment, water quality and temperature, prevention of stains and damage to reusable textiles, maintenance, handling, transportation receiving, storage of reusable soiled and cleaned textiles, and laundering. t) Annexes have been updated. CSA acknowledges that the development of this Standard was made possible, in part, by the financial support of the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Québec, Saskatchewan, and Yukon, as administered by the Canadian Agency for Drugs and Technologies in Health (CADTH). This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard. This Standard was prepared by the Technical Committee on Medical Device Reprocessing, under the jurisdiction of the Strategic Steering Committee on Health and Well-Being and has been formally approved by the Technical Committee. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. 

Scope 

1.1 Standard addresses 

This Standard is intended to address the safe, effective, and reliable reprocessing of reusable medical devices at each phase of the reprocessing workflow, including a) establishing a QMS for the MDRA, including i) key performance indicators; ii) policies and procedures; iii) documentation; iv) roles and responsibilities; v) management review; vi) planning, resources, and operations; vii) environmental conditions and infrastructure; and viii) recalls and alerts; b) personnel requirements, including i) qualifications; ii) occupational health and safety; and iii) infection prevention and control; c) manufacturer’s instructions for use (MIFUs); d) evaluation and purchase of reprocessing equipment and reusable medical devices; e) loaned, reusable medical devices; f) work areas and design; g) environmental conditions; h) utilities (e.g., power supply, water, and steam quality); i) the reprocessing workflow, including i) decontamination; ii) preparation of medical devices for reprocessing; iii) sterile barrier systems; iv) sterilization methods; v) storage, transportation, and distribution; and vi) equipment maintenance and quality assurance; j) sterile storage; k) selection and use of gowns and drapes; and l) laundering, maintenance, and preparation of reusable gowns, drapes, and wrappers. 

1.2 Health care settings standard applies to 

This Standard applies to health care settings or providers where medical device reprocessing (MDR) occurs including, but not limited to, a) all acute care hospitals; b) trauma centres; c) emergency care facilities; d) medical clinics with or without overnight stay or observation; e) endoscopy centres; f) laser eye clinics; g) outpatient surgical services; h) cosmetic surgical offices; i) dental general and surgical facilities; j) other office surgical facilities; k) general physician offices (with and without treatment spaces); l) stand-alone laboratory facilities; m) diagnostic imaging centres; n) nursing homes; o) long-term care facilities; p) assisted-living facilities; q) mental health facilities; r) forensic facilities; s) rehabilitation facilities; t) health care professional offices (e.g., occupational therapy, physiotherapy, ostomy); u) chronic care facilities; v) group homes; w) hospice care facilities; x) stand-alone dialysis clinics; y) ambulatory clinics; z) walk-in health clinics and independent doctor’s offices; aa) pediatric clinics; bb) public health clinics; cc) adult daycare centres; dd) third-party reprocessors; ee) educational settings; ff) community health centres; gg) private practices for health care professionals (e.g., foot care or any home based reprocessing); and hh) additional health care settings as applicable. 

1.3 Standard does not apply 

This Standard does not address a) reprocessing of single-use/disposable medical devices; Notes: 1) Information concerning safety, technology, cost/benefit, and legal issues involving the reuse of such medical devices is found in such publications as CADTH (2015). 2) See also Health Canada Update: Notice to Stakeholders — Health Canada’s Regulatory Approach to Commercial Reprocessing of Medical Devices Originally Labelled for Single Use, available at b) sterilization by injecting ethylene oxide (EO) or mixtures containing EO directly into packages or a flexible chamber; and c) medical devices that have been used with patients (clients) who are known or suspected to have Creutzfeldt–Jakob Disease (CJD) or prion-related diseases. Note: See PHAC’s Infection Control Guidelines: Classic Creutzfeldt — Jakob disease in Canada. Quick Reference Guide. 

1.4 Terminology 

In this Standard, "shall" is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the Standard; "should" is used to express a recommendation or that which is advised but not required; and "may" is used to express an option or that which is permissible within the limits of the Standard. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Notes to tables and figures are considered part of the table or figure and may be written as requirements. Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.