[ Pobierz całość w formacie PDF ]
13. Flash Sterilization
Flash sterilization shall only be used in emergency situations and shall not be used for implantable
equipment/devices1, 23 or on complete sets or trays of instruments.1 Sterilization is a process, not an
event. Operative scheduling and lack of instrumentation do not qualify as reasons to use flash
sterilization.
Effective sterilization is impaired if all the necessary parameters of the process are not met. These
include, but are not limited to, the following:
a) decontamination and sterilization areas must meet the requirements for processing space as
noted in Appendix B ( Recommendations for Physical Space for Reprocessing ) and shall not be
located in the operative procedure room or near any potential source of contamination, such as
sinks, hoppers, linen or trash disposal areas1;
b) a record for each piece of equipment/device being subjected to flash sterilization that includes the
name of the client/patient/resident, procedure, physician/practitioner and equipment/device used1;
the client/patient/resident record should also reflect this information;
c) if, in an emergency situation, a flash sterilizer is used, a biological monitor must be included at
least once daily and with each type of cycle1 and every load configuration (i.e., open tray, rigid
flash container, single wrapper) that will be used that day;
d) the load printout must be signed to verify that the required time, temperature and pressure have
been achieved;
e) records must be retained according to the facility s policy1;
f) there must be a procedure for notification of the client/patient/resident in the event of a recall
(e.g., positive biological indicator); and
g) records should be reviewed on a regular basis to correct issues relating to overuse of flash
sterilization.
| Page 51 of 109 pages
Best Practices for Cleaning, Disinfection and Sterilization in All Health Care Settings February, 2010
For more information regarding the use and requirements of flash sterilization, refer to CSA
Standard Z314.3-09, Effective Sterilization in Health Care Facilities by the Steam Process
[Section 13].
Recommendations:
75. Flash sterilization shall only be used in emergency situations and must never be used for
implantable equipment/devices.
14. Unacceptable Methods of Disinfection/Sterilization
The following methods of disinfection/sterilization are not recommended.
A. Boiling
The use of boiling water to clean instruments and utensils is not an effective means of sterilization.23
Boiling water is inadequate for the destruction of bacterial spores and some viruses.
In the home care environment, boiling may be used for high-level disinfection for equipment/devices re-
used on the same client, following adequate cleaning.
B. Ultraviolet Irradiation
The germicidal effectiveness of ultraviolet (UV) radiation is influenced by organic matter, wavelength, type
of suspension, temperature, type of microorganism and UV intensity, which is affected by distance and
dirty tubes.28 The application of UV light in the health care setting is limited to the destruction of airborne
organisms (e.g., ventilation ducts) or inactivation of microorganisms located on surfaces (e.g., laboratory
hoods). It is not an acceptable method of disinfection/sterilization for medical equipment/devices.23
C. Glass Bead Sterilization
Glass bead sterilizers use small glass beads and high temperature for brief exposure times to inactivate
microorganisms.28 Glass bead sterilizers are difficult to monitor for effectiveness, have inconsistent
heating resulting in cold spots, and often have trapped air which affects the sterilization process.
The U.S. Food and Drug Administration has determined that a risk of infection exists with this equipment
because of their potential failure to sterilize dental instruments and has required their commercial
distribution cease until the device has received FDA clearance.28, 42 Glass bead sterilization is not an
acceptable method of sterilization for medical equipment/devices.23, 43
D. Chemiclave
Unsaturated chemical-vapour sterilization ( chemiclave ) involves heating a chemical solution of primarily
alcohol with 0.23% formaldehyde in a closed pressurized chamber. Because of the environmental risks
associated with formaldehyde, this method of sterilization is discouraged. If used, it must be closely
monitored44 and local regulations for hazardous waste disposal must be followed and air sampling for
toxic vapours may be indicated.
| Page 52 of 109 pages
Best Practices for Cleaning, Disinfection and Sterilization in All Health Care Settings February, 2010
E. Microwave Oven Sterilization
Microwave ovens are unreliable and difficult to monitor for effective sterilization. Home microwaves have
been shown to inactivate bacteria, viruses, mycobacteria and some spores, however there may not be
even distribution of microwave energy over the entire device.28 More research and testing is required to
validate the use of microwave ovens for sterilization. The use of microwave ovens for sterilization of
medical equipment/devices is not currently acceptable.23, 28
Recommendations:
76. Boiling is not an acceptable method of sterilization.
77. The use of ultraviolet light is not an acceptable method of disinfection/sterilization.
78. Glass bead sterilization is not an acceptable method of sterilization.
79. The use of a chemiclave for sterilization poses an environmental risk and must be closely
monitored.
80. The use of microwave ovens for sterilization is not acceptable.
15. Continued Monitoring and System Failures
Recalls
Improper reprocessing includes, but is not limited to, the following situations:
a) the load contains a positive BI23;
b) an incorrect reprocessing method was used on the equipment/device;
c) print-outs on reprocessing equipment indicate failure to reach correct parameters (e.g.,
temperature, pressure, exposure time);
d) CI or monitoring tape has not changed colour; and
e) there is doubt about the sterility of medical equipment/devices.1
A written procedure must be established for the recall and reprocessing of improperly reprocessed
medical equipment/devices.1 All equipment/devices in each processed load must be recorded to enable
tracking in the event of a recall. The recall procedure should include:
a) designation of department and staff responsible for executing the recall1;
b) identification of the medical equipment/devices to be recalled1; if recall is due to a failed BI, the
recall shall include the medical devices in the failed load as well as all other devices processed in [ Pobierz całość w formacie PDF ]
zanotowane.pl doc.pisz.pl pdf.pisz.pl freetocraft.keep.pl
13. Flash Sterilization
Flash sterilization shall only be used in emergency situations and shall not be used for implantable
equipment/devices1, 23 or on complete sets or trays of instruments.1 Sterilization is a process, not an
event. Operative scheduling and lack of instrumentation do not qualify as reasons to use flash
sterilization.
Effective sterilization is impaired if all the necessary parameters of the process are not met. These
include, but are not limited to, the following:
a) decontamination and sterilization areas must meet the requirements for processing space as
noted in Appendix B ( Recommendations for Physical Space for Reprocessing ) and shall not be
located in the operative procedure room or near any potential source of contamination, such as
sinks, hoppers, linen or trash disposal areas1;
b) a record for each piece of equipment/device being subjected to flash sterilization that includes the
name of the client/patient/resident, procedure, physician/practitioner and equipment/device used1;
the client/patient/resident record should also reflect this information;
c) if, in an emergency situation, a flash sterilizer is used, a biological monitor must be included at
least once daily and with each type of cycle1 and every load configuration (i.e., open tray, rigid
flash container, single wrapper) that will be used that day;
d) the load printout must be signed to verify that the required time, temperature and pressure have
been achieved;
e) records must be retained according to the facility s policy1;
f) there must be a procedure for notification of the client/patient/resident in the event of a recall
(e.g., positive biological indicator); and
g) records should be reviewed on a regular basis to correct issues relating to overuse of flash
sterilization.
| Page 51 of 109 pages
Best Practices for Cleaning, Disinfection and Sterilization in All Health Care Settings February, 2010
For more information regarding the use and requirements of flash sterilization, refer to CSA
Standard Z314.3-09, Effective Sterilization in Health Care Facilities by the Steam Process
[Section 13].
Recommendations:
75. Flash sterilization shall only be used in emergency situations and must never be used for
implantable equipment/devices.
14. Unacceptable Methods of Disinfection/Sterilization
The following methods of disinfection/sterilization are not recommended.
A. Boiling
The use of boiling water to clean instruments and utensils is not an effective means of sterilization.23
Boiling water is inadequate for the destruction of bacterial spores and some viruses.
In the home care environment, boiling may be used for high-level disinfection for equipment/devices re-
used on the same client, following adequate cleaning.
B. Ultraviolet Irradiation
The germicidal effectiveness of ultraviolet (UV) radiation is influenced by organic matter, wavelength, type
of suspension, temperature, type of microorganism and UV intensity, which is affected by distance and
dirty tubes.28 The application of UV light in the health care setting is limited to the destruction of airborne
organisms (e.g., ventilation ducts) or inactivation of microorganisms located on surfaces (e.g., laboratory
hoods). It is not an acceptable method of disinfection/sterilization for medical equipment/devices.23
C. Glass Bead Sterilization
Glass bead sterilizers use small glass beads and high temperature for brief exposure times to inactivate
microorganisms.28 Glass bead sterilizers are difficult to monitor for effectiveness, have inconsistent
heating resulting in cold spots, and often have trapped air which affects the sterilization process.
The U.S. Food and Drug Administration has determined that a risk of infection exists with this equipment
because of their potential failure to sterilize dental instruments and has required their commercial
distribution cease until the device has received FDA clearance.28, 42 Glass bead sterilization is not an
acceptable method of sterilization for medical equipment/devices.23, 43
D. Chemiclave
Unsaturated chemical-vapour sterilization ( chemiclave ) involves heating a chemical solution of primarily
alcohol with 0.23% formaldehyde in a closed pressurized chamber. Because of the environmental risks
associated with formaldehyde, this method of sterilization is discouraged. If used, it must be closely
monitored44 and local regulations for hazardous waste disposal must be followed and air sampling for
toxic vapours may be indicated.
| Page 52 of 109 pages
Best Practices for Cleaning, Disinfection and Sterilization in All Health Care Settings February, 2010
E. Microwave Oven Sterilization
Microwave ovens are unreliable and difficult to monitor for effective sterilization. Home microwaves have
been shown to inactivate bacteria, viruses, mycobacteria and some spores, however there may not be
even distribution of microwave energy over the entire device.28 More research and testing is required to
validate the use of microwave ovens for sterilization. The use of microwave ovens for sterilization of
medical equipment/devices is not currently acceptable.23, 28
Recommendations:
76. Boiling is not an acceptable method of sterilization.
77. The use of ultraviolet light is not an acceptable method of disinfection/sterilization.
78. Glass bead sterilization is not an acceptable method of sterilization.
79. The use of a chemiclave for sterilization poses an environmental risk and must be closely
monitored.
80. The use of microwave ovens for sterilization is not acceptable.
15. Continued Monitoring and System Failures
Recalls
Improper reprocessing includes, but is not limited to, the following situations:
a) the load contains a positive BI23;
b) an incorrect reprocessing method was used on the equipment/device;
c) print-outs on reprocessing equipment indicate failure to reach correct parameters (e.g.,
temperature, pressure, exposure time);
d) CI or monitoring tape has not changed colour; and
e) there is doubt about the sterility of medical equipment/devices.1
A written procedure must be established for the recall and reprocessing of improperly reprocessed
medical equipment/devices.1 All equipment/devices in each processed load must be recorded to enable
tracking in the event of a recall. The recall procedure should include:
a) designation of department and staff responsible for executing the recall1;
b) identification of the medical equipment/devices to be recalled1; if recall is due to a failed BI, the
recall shall include the medical devices in the failed load as well as all other devices processed in [ Pobierz całość w formacie PDF ]