Preface
This is the third edition of CSA Z314.8, Decontamination of reusable medical devices. It supersedes the previous editions, published in 2000 under the same title and in 1998 under the title Reprocessing of Reusable Medical and Surgical Supplies. It is one in a series of CSA Standards dealing with decontamination, disinfection, and sterilization.
1 Scope
1.1
This Standard describes essential elements and methods in the safe handling, transportation, and biological decontamination of contaminated reusable medical devices.
Note: The biological decontamination process includes thorough cleaning and, whenever necessary for personnel or patient safety, appropriate application of a disinfection process.
1.2
This Standard includes requirements for
(a) policies, procedures, and quality systems;
(b) evaluation and purchase of reusable medical devices;
(c) qualification, education, and training of personnel;
(d) protective attire;
(e) decontamination areas and equipment;
(f) immediate handling of contaminated medical devices at the point of use;
(g) transport of contaminated medical devices;
(h) 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 fiber-optic endoscopes, and electronic patient-applied devices).
Note: More detailed procedures can be required for specific medical devices or applications.
1.3
This Standard does not apply to
(a) the terminal sterilization of reusable medical devices;
Note: See CAN/CSA-Z314.2, CAN/CSA-Z314.3, and CAN/CSA-ISO 14937.
(b) single-use/disposable medical devices;
Note: Information concerning safety, technology, cost/benefit, and legal issues involving the reuse of such devices is found in such publications 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 Health Canada (2007).
(d) the reprocessing and reuse of haemodialyzers.
Note: See CAN/CSA-Z364.1.3.
1.4
In CSA Standards, "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; "may" is used to express an option or that which is permissible within the limits of the standard; and "can" is used to express possibility or capability. 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.
| Edition : | 3rd |
| ISBN(s) : | 9781554366521 |
| Number of Pages : | 110 |
| Published : | 03/01/2008 |
