Historical
CSA Z314.0-2013
Z314.0-13 - Medical device reprosessing - General requirements
Preface
This is the first edition of CSA Z314.0, Medical device reprocessing - General requirements. It is the core Standard in a series of CSA Group Standards dealing with the safe and effective sterilization of medical supplies and equipment.Scope
1.1 This Standard is intended to form the basis of a QMS within a health care setting for the purpose of providing safe, reliable reprocessing of reusable medical devices and is designed to be used with the CSA Z314 series of Standards addressing specific aspects of medical device reprocessing. A comprehensive QMS can be achieved when this Standard is used in combination with related subject specific standard(s) in the CSA Z314 series:- CSA Z314.1;
- CSA Z314.3;
- CAN/CSA-Z314.8;
- CSA Z314.9;
- CSA Z314.10.1;
- CSA Z314.10.2;
- CSA Z314.14;
- CSA Z314.15;
- CAN/CSA-Z314.22; and
- CSA Z314.23
- quality management, including
- policies and procedures;
- documentation;
- roles and responsibilities;
- management review;
- personnel qualifications and training; and
- adverse event management (e.g., recalls);
- occupational health and safety;
- evaluation and purchase of reprocessing equipment and reusable medical devices;
- infection prevention and control;
- work areas and equipment;
- environmental conditions; and
- utilities (e.g., power supply, water, and steam quality).
- all acute care hospitals;
- trauma centres;
- emergency care facilities;
- medical clinics with or without overnight stay or observation;
- endoscopy centres;
- laser eye clinics;
- outpatient surgical services;
- cosmetic surgical offices;
- dental general and surgical facilities;
- other office surgical facilities;
- general physician offices (with and without treatment spaces);
- stand-alone laboratory facilities;
- diagnostic imaging centres;
- nursing homes;
- long-term care facilities;
- assisted-living facilities;
- mental health facilities;
- forensic facilities;
- rehabilitation facilities;
- additional services facilities;
- chronic care facilities;
- group homes;
- hospice care facilities;
- stand-alone dialysis clinics;
- ambulatory clinics;
- walk-in health clinics;
- physiotherapy clinics;
- pediatric clinics;
- public health clinics;
- adult daycare centres;
- third-party reprocessors; and
- educational settings.
- 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 the Canadian Healthcare Association (1996), ECRI Institute (1997), and the Canadian Agency for Drugs and Technologies in Health (CADTH 2011).
- 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 Public Health Agency of Canada (formerly Health Canada) Classic Creutzfeldt-Jakob Disease in Canada - Quick Reference Guide (2007) and Classic Creutzfeldt-Jakob Disease in Canada (2002).
Content Provider
CSA America, Inc. [csa]