1.
Scope
1.1
This Standard describes essential elements and methods in the safe handling, transportation, and biological decon tamination 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 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-Jakob 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 f igure or table and may be written as mandatory requirements; legends to figures are also considered part of the requirements of the figure.
| Number of Pages : | 68 |
| Published : | 06/12/2000 |
