CAN/CSA-Z314-18

Preface
0 Introduction
1 Scope
2 Reference publications
3 Definitions
4 General requirements
5 Quality management system (QMS)
6 Personnel
7 Manufacturer's instructions for use (MIFUs)
8 Evaluation and purchase of reusable medical devices,
   reprocessing equipment, sterile barrier systems,
   and consumables
9 Loaned, reusable medical devices
10 Work areas and design
11 Decontamination of reusable medical devices
12 Flexible endoscopes
13 Ultrasound transducer probes
14 Preparation of medical devices for reprocessing
15 Selection and use of sterile barrier systems
16 Sterilization methods
17 Storage, transportation, and distribution of single-use
   and reusable medical devices
18 Equipment maintenance and quality assurance
19 Selection and use of gowns and drapes
20 Laundering, maintenance, and preparation of reusable
   gowns, drapes, and wrappers
Annex A (informative) - Applying CAN/CSA-ISO 9001 QMS
        requirements to medical device reprocessing
Annex B (informative) - Risk management and sterility
        assurance
Annex C (informative) - Sample forms and tools for MDRDs
Annex D (informative) - Donning and doffing of PPE
Annex E (normative) - Information to be supplied by the
        sterilization container manufacturer
Annex F (informative) - Guidance for the design of medical
        device reprocessing areas
Annex G (informative) - Water quality
Annex H (informative) - Steam quality
Annex I (informative) - Indicators for sterilization monitoring
Annex J (informative) - Examples for performance qualification
        of products and loads
Annex K (informative) - Guidance on selection of gowns
Annex L (informative) - Moisture assessment
Annex M (informative) - Suggested methods for preparing and
        folding packs, gowns, and drapes
Annex N (informative) - Guidance for the purchase of
        sterilization container systems
Annex O (informative) - Properties of sterilization wrappers
Annex P (informative) - Specifications and calculations for
        the density of reusable textile packages
Annex Q (informative) - High relative humidity in sterile
        storage areas
Annex R (informative) - Guidance on storage and handling
Annex S (informative) - Guidance on selection of an automated
        storage system
Annex T (informative) - Evaluation criteria for laundries
Annex U (informative) - Guidance for the design of laundering
        and laundry areas

You must be logged-in for free view access. Preface This is the first edition of CAN/CSA-Z314, Canadian medical device reprocessing. It replaces CSA Z314.0, Z314.3, Z314.8, Z314.10.1, Z314.10.2, Z314.14, Z314.15, Z314.22, and Z314.23. This Standard addresses the safe and effective reprocessing of medical devices and supplies. 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 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 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 MDRD, 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 This Standard applies to health care settings or providers where medical device reprocessing 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) additional services facilities; u) chronic care facilities; v) group homes; w) hospice care facilities; x) stand-alone dialysis clinics; y) ambulatory clinics; z) walk-in health clinics; aa) physiotherapy clinics; ab) pediatric clinics; ac) public health clinics; ad) adult daycare centres; ae) third-party reprocessors; af) educational settings; and ag) private entrepreneurs. 1.3 This Standard does not address a) single-use/disposable medical devices; and Note: Information concerning safety, technology, cost/benefit, and legal issues involving the reuse of such medical devices is found in such publications as, CADTH (2015). See also https://www.canada.ca/en/healthcanada/services/drugs-health-products/medical-devices/activities/announcements/update-noticestakeholders-regulatory-approach-commercial-reprocessing-medical-devices-originally-labelled-single-use.html. b) medical devices that have been used with patients who are known or suspected to have Creutzfeldt-Jakob Disease (CJD) or prion-related diseases. Note: See the PHAC’s Classic Creutzfeldt-Jakob Disease in Canada — Quick Reference Guide and Infection Control Guidelines: Classic Creutzfeldt-Jakob Disease in Canada. 1.4 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.

You must be logged-in for free view access. Preface This is the first edition of CAN/CSA-Z314, Canadian medical device reprocessing. It replaces CSA Z314.0, Z314.3, Z314.8, Z314.10.1, Z314.10.2, Z314.14, Z314.15, Z314.22, and Z314.23. This Standard addresses the safe and effective reprocessing of medical devices and supplies. 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 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 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 MDRD, 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 This Standard applies to health care settings or providers where medical device reprocessing 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) additional services facilities; u) chronic care facilities; v) group homes; w) hospice care facilities; x) stand-alone dialysis clinics; y) ambulatory clinics; z) walk-in health clinics; aa) physiotherapy clinics; ab) pediatric clinics; ac) public health clinics; ad) adult daycare centres; ae) third-party reprocessors; af) educational settings; and ag) private entrepreneurs. 1.3 This Standard does not address a) single-use/disposable medical devices; and Note: Information concerning safety, technology, cost/benefit, and legal issues involving the reuse of such medical devices is found in such publications as, CADTH (2015). See also https://www.canada.ca/en/healthcanada/services/drugs-health-products/medical-devices/activities/announcements/update-noticestakeholders-regulatory-approach-commercial-reprocessing-medical-devices-originally-labelled-single-use.html. b) medical devices that have been used with patients who are known or suspected to have Creutzfeldt-Jakob Disease (CJD) or prion-related diseases. Note: See the PHAC’s Classic Creutzfeldt-Jakob Disease in Canada — Quick Reference Guide and Infection Control Guidelines: Classic Creutzfeldt-Jakob Disease in Canada. 1.4 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.