CSA Z314.8-14

Preface

This is the fourth edition of CSA Z314.8 Decontamination of reusable medical devices. It supersedes the previous editions published in 2008, 2000, and 1998. It is one of a series of CSA Standards dealing with the safe and effective sterilization of medical supplies and equipment.

This new edition provides users with an expanded section on endoscopy, including a table providing guidance on timely reprocessing. Requirements explained in terms of A0 values are also introduced.

This Standard is to be used in conjunction with CSA Z314.0, Medical device reprocessing - General requirements, which provides the framework to establish, document, and maintain policies and procedures for the reprocessing of medical devices to develop a Quality Management System (QMS).

Scope

1.1
This Standard describes essential elements and methods in the safe handling, transportation, and biological decontamination of contaminated reusable medical devices and is to be used in conjunction with CSA Z314.0. Where differences exist, the requirements of this Standard apply.

Note: The biological decontamination process includes thorough cleaning and, whenever necessary for personnel or patient safety, appropriate application of a disinfection or sterilization process.

1.2
This Standard includes requirements for

a) decontamination areas and equipment;

b) immediate handling of contaminated medical devices at the point of use;

c) transport of contaminated medical devices; and

d) decontamination policies and procedures (in general, as related to reusable diagnostic and therapeutic medical devices, and specifically, as related to reusable respiratory/anaesthesia devices, flexible fibre optic endoscopes, ultrasound transducer probes, and electronic patient-applied devices).

Notes:

1) More detailed procedures can be required for specific medical devices or applications.

2) See Figure 1 for an overview of the medical device reprocessing steps specified in this Standard.

1.3
This Standard does not apply to

a) the terminal sterilization of reusable medical devices;

Note: See CSA Z314.0, CSA Z314.3, CSA Z314.23, and CAN/CSA-ISO 14937.

b) single-use/disposable medical device reprocessing;

Note: Information concerning safety, technology, cost/benefit, and legal issues involving the reuse of single use/disposable devices is found in publications such as Canadian Healthcare Association (1996) and Emergency Care Research Institute (1997).

c) medical devices that have been used with patients who are known or suspected to have Creutzfeldt-Jakob disease or prion-related diseases; and

Note: See Public Health Agency of Canada's Variant Creutzfeld-Jakob Disease (vCJD) and Infection Control Guidelines: Classic Creutzfeldt-Jakob Disease in Canada: Quick Reference Guide.

d) the reprocessing and reuse of haemodialyzers.

Note: See CAN/CSA-Z364.1.3.

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.