Codes & Standards - Purchase
CAN/CSA-Z314.8-00 (R2005)
Decontamination of Reusable Medical Devices
SKU: 2413278
Published by CSA Group
Publication Year 2000
Reaffirmed in 2005
68 pages
Withdrawn
Product Details
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.
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.