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Overview
ORNAC, 15th edition
The intended application of these standards is for the perioperative environment. It is the responsibility of the individual perioperative RN and health care organization to ensure that the most current recommendations are being used. It is the responsibility of the users of this document to apply it in the context of their individual setting, respecting federal and provincial/territorial regulations and laws.
The 2021 Standards Committee is excited to present this edition. The front matter has been updated with ORNAC’s new mission, vision, and values statements and information regarding scope of practice. Additionally, we have included updates to Section 2 regarding gloves, eyewear, and masks and Section 3 regarding venous thromboembolism (VTE). Significant content has been added to Section 5; the standards in 5.10 Pandemic Planning identify best practices during pandemic/epidemic situations. This new content will serve to lay the groundwork for evidence-based practices as they continue to evolve. The entire document has been edited for compliance with Publication manual of the American Psychological Association (APA) 7th edition.
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CAN/CSA-Z314-18, Canadian medical device reprocessing
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;
