CAN/CSA-Z314.8-00 (R2007)

1. Scope 1.1 This Standard describes essential elements and methods in the safe handling, transportation, and biological decontamination of contaminated reusable medical devices (see Figure 1). Note: The biological decontamination process includes thorough cleaning and, whenever necessary for personnel or patient safety, appropriate application of a microbicidal process (disinfection or sterilization). 1.2 This Standard includes requirements for (a) qualification, education, and training of personnel; (b) design of decontamination areas; (c) protective attire; (d) immediate handling of contaminated medical devices at the point of use; (e) transport of contaminated medical devices; (f) emergency preparedness (spills); and (g) 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, and electronic patient-applied devices). Note: It is recognized that more detailed procedures may 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: Refer to CSA Standards CAN/CSA-Z314.2, CAN/CSA-Z314.3, and ISO Draft Standard ISO/DIS 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 the Canadian Healthcare Association's The Reuse of Single-Use Medical Devices: Guidelines for Healthcare Facilities and ECRI's Reuse of Medical Devices: Making Informed Decisions. (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: Refer to the following Health Canada publication: Infection Control Guidelines for Healthcare Workers for Creutzfeldt-Jacob Disease in Canada (in progress). (d) the reprocessing and reuse of haemodialyzers. Note: Refer to CSA Standard CAN/CSA-Z364.1.3. 1.4 In this Standard, "shall" indicates a mandatory requirement; "should" indicates a recommendation or that which is advised but not mandatory; and "may" indicates an advisory or optional statement. Notes accompanying clauses do not include mandatory or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material that is not properly a part of the Standard. Notes to figures and tables are considered part of the figure or table and may be written as mandatory requirements; legends to figures are also considered part of the requirements of the figure.