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Dear all,
Find below the FDA notification of the New Reprocessing Instructions for the
Olympus TJF-Q180V duodenoscopes.Attached is the Olympus letter to customers which details the new
reprocessing instructions including;. supplementary flushing instructions
. additional recess flushing and forceps elevator raising /lowering
steps during pre-cleaning. manual cleaning
. manual disinfection and endoscope rinsing and alcohol flushing.
Olympus advise that “these new reprocessing procedures should be implemented
as soon as possible” and that “the new cleaning procedure requires the use
of a small bristle cleaning brush (MAJ_1888) which Olympus anticipates
shipping no later than May 8, 2015”The key differences include the following:
Pre cleaning
. During immersion, raise and lower the elevator 3 times
Manual cleaning
. Additional brushing of the forceps elevator recess area using an
additional brush (MAJ-1888 brush). Additional flushing of forceps elevator recess area
. Additional raising and lowering the forceps elevator
Manual high level disinfection
. Additional manual flushing steps and increased flushing volume of
the endoscope channel and forceps recess area. Additional raising and lowering of the forceps elevator
Regards
Glenys
Glenys Harrington
Consultant
Infection Control Consultancy (ICC)
PO Box 5202
Middle Park
Victoria, 3206
Australia
M: +61 404 816 434
ABN 47533508426
Communication – New Reprocessing Instructions Validated
MedWatch logo
MedWatch – The FDA Safety Information and Adverse Event Reporting Program
Duodenoscope Model TJF-Q180V by Olympus: FDA Safety Communication – New
Reprocessing Instructions ValidatedEngineering, Patient
for the TJF-Q180V duodenoscope to replace those provided in the original
labeling. The FDA has reviewed these new reprocessing instructions and the
validation data as part of its ongoing review of the 510(k), and recommends
that any facilities that are using Olympus’ TJF-Q180V duodenoscope train
staff on the new instructions and implement them as soon as possible.disinfect or sterilize reusable devices. The FDA is closely monitoring the
possible association between reprocessed duodenoscopes and the transmission
of infectious agents, including multidrug-resistant bacterial infections
caused by Carbapenem-Resistant Enterobacteriaceae (CRE) such as Klebsiella
species and Escherichia coli. If not properly reprocessed, residual body
fluids and organic debris may remain in microscopic crevices of the device
following an attempted cleaning and high level disinfection. If these
residual fluids contain microbial contamination, subsequent patients may be
exposed to serious infections. The FDA’s investigation into the possible
association between inadequately reprocessed duodenoscopes and patient
infections, including the agency’s recommendations for health care
facilities, is more fully discussed in the following recent communications:
February 2015 Safety Communication
and FDA’s Updated Information for Healthcare Providers Regarding
Duodenoscopes issued March 4, 2015.facilities and other users of the TJF-Q180V outlining the new, validated
reprocessing instructions, and will soon be distributing revised user
manuals. Key changes have been made to the Precleaning, Manual Cleaning,
Manual High Level Disinfection reprocessing procedures for Olympus’
TJF-Q180V duodenoscope. Please see the FDA Safety Communication
for more details. In addition, FDA has the following recommendations
for facilities and staff that use and reprocess the Olympus TJF-Q180V:*Implement the new manual cleaning and high level disinfection
procedures for the Olympus TJF-Q180V duodenoscope in accordance with the
manufacturer’s reprocessing instructions.
*Train appropriate staff on Olympus’ new reprocessing instructions
and implement them as soon as possible.
*Contact Olympus directly with specific questions and concerns or to
schedule a site visit with their Endoscopy Support Specialists Technical
Assistance Center (TAC), 1-800-848-9024, option 1 Monday – Friday between
7AM EST – 8 PM EST.Healthcare professionals and patients are encouraged to report adverse
events or side effects related to the use of these products to the FDA’s
MedWatch Safety Information and Adverse Event Reporting Program:*Complete and submit the report Online: http://www.fda.gov/MedWatch/report
* Download form
or call 1-800-332-1088 to request a reporting form, then complete and
return to the address on the pre-addressed form, or submit by fax to
1-800-FDA-0178Read the MedWatch Safety Alert, inclusing links to the FDA Safety
Communication at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMed
icalProducts/ucm440098.htm_____
You are encouraged to report all serious adverse events and product quality
problems to FDA MedWatch at http://www.fda.gov/medwatch/report.htmFollow MedWatch on Twitter
twitterUpdate your subscriptions, modify your e-mail address, or stop subscriptions
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Glenys et al
Thank you for this really interesting commentary which again highlights the challenge of new technologies and our need for constant vigilance. As you are aware for many years Australia and I think parts of Canada have been outliers in terms of recommending regular sampling of scopes.
APIC is currently writing an article for their Infection Preventionist magazine on duodenoscopes and have asked me to draft a few words on Australia’s approach to routine culturing as per GENCA Guidelines. APIC is particularly keen to share with their members the practical ways in which routine culturing is undertaken. I feel compelled to provide a broad overview and examples of different organisation’s practices and especially any difficulties w/ complying w/ sampling. I understand how 2 large SE QLD hospitals did it. I am familiar w/ the GENCA Guidelines and CHRISP protocols but I wondered if any on this list would be willing to offer insights. Dot points would be fine. I suspect that issues like:
– time taken for results
– lack of additional circulating scopes
– access to micro labs
– standardised procedure
– action in the event of positive culture
– clearance/ repeat reprocessing and culturing
– ? need for Lookback, suspension of duodenoscopic services until clearanceetc
may all be potentially problematic.Would list members who are willing to help me please post here ASAP as I am past the APIC deadline, or email me directly. Copies of local policy would be especially helpful .I am very happy to attribute anyone who provides insight (or have them remain anonymous as desired) and thank you in advance. I am also happy to share the final draft w/ any list members who may be interested.
Regards
CathDr Cathryn Murphy RN MPH PhD CIC
Executive Director
Infection Control Plus Pty Ltd
Cath@infectioncontrolplus.com.au
http://www.infectioncontrolplus.com.au
[Description: twitter logo][Description: FB logo][Description: icp icon]Dear all,
Find below the FDA notification of the New Reprocessing Instructions for the Olympus TJF-Q180V duodenoscopes.
Attached is the Olympus letter to customers which details the new reprocessing instructions including;
* supplementary flushing instructions
* additional recess flushing and forceps elevator raising /lowering steps during pre-cleaning
* manual cleaning
* manual disinfection and endoscope rinsing and alcohol flushing.
Olympus advise that “these new reprocessing procedures should be implemented as soon as possible” and that “the new cleaning procedure requires the use of a small bristle cleaning brush (MAJ_1888) which Olympus anticipates shipping no later than May 8, 2015”
The key differences include the following:
Pre cleaning
* During immersion, raise and lower the elevator 3 times
Manual cleaning* Additional brushing of the forceps elevator recess area using an additional brush (MAJ-1888 brush)
* Additional flushing of forceps elevator recess area
* Additional raising and lowering the forceps elevator
Manual high level disinfection* Additional manual flushing steps and increased flushing volume of the endoscope channel and forceps recess area
* Additional raising and lowering of the forceps elevator
Regards
Glenys
Glenys Harrington
Consultant
Infection Control Consultancy (ICC)
PO Box 5202
Middle Park
Victoria, 3206
Australia
M: +61 404 816 434
infexion@ozemail.com.au
ABN 47533508426[MedWatch logo][MedWatch – The FDA Safety Information and Adverse Event Reporting Program]
Duodenoscope Model TJF-Q180V by Olympus: FDA Safety Communication – New Reprocessing Instructions Validated
* Implement the new manual cleaning and high level disinfection procedures for the Olympus TJF-Q180V duodenoscope in accordance with the manufacturer’s reprocessing instructions.
* Train appropriate staff on Olympus’ new reprocessing instructions and implement them as soon as possible.
* Contact Olympus directly with specific questions and concerns or to schedule a site visit with their Endoscopy Support Specialists Technical Assistance Center (TAC), 1-800-848-9024, option 1 Monday – Friday between 7AM EST – 8 PM EST.Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
* Complete and submit the report Online: http://www.fda.gov/MedWatch/report
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178Read the MedWatch Safety Alert, inclusing links to the FDA Safety Communication at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm440098.htm
________________________________
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at http://www.fda.gov/medwatch/report.htm
Follow MedWatch on Twitter
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
[FDA][HHS]
________________________________
This email was sent to infexion@ozemail.com.au using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) * 10903 New Hampshire Ave * Silver Spring, MD 20993 * 800-439-1420[Powered by GovDelivery]
MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.
The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.
Archive of all messages are available at http://aicalist.org.au/archives – registration and login required.
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MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.
The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.
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Dear all,
Further to my previous correspondence re: this topic, on 4th June 2015
Olympus have released the attached URGENT Recall for Product Correction Re:
TJF-Q180V Duodenoscope (TGA Ref #: RC-2015-RN-00475-1, ARTG Number: 210858)Please share with your colleagues working in Endoscopy Units
Regards
Glenys
Glenys Harrington
Consultant
Infection Control Consultancy (ICC)
PO Box 5202
Middle Park
Victoria, 3206
Australia
M: +61 404 816 434
ABN 47533508426
Of Glenys Harrington
Endoscopic Retrograde Cholangiopancreatography – New Reprocessing
Instructions for the Olympus TJF-Q180V duodenoscopesDear all,
Find below the FDA notification of the New Reprocessing Instructions for the
Olympus TJF-Q180V duodenoscopes.Attached is the Olympus letter to customers which details the new
reprocessing instructions including;. supplementary flushing instructions
. additional recess flushing and forceps elevator raising /lowering
steps during pre-cleaning. manual cleaning
. manual disinfection and endoscope rinsing and alcohol flushing.
Olympus advise that “these new reprocessing procedures should be implemented
as soon as possible” and that “the new cleaning procedure requires the use
of a small bristle cleaning brush (MAJ_1888) which Olympus anticipates
shipping no later than May 8, 2015”The key differences include the following:
Pre cleaning
. During immersion, raise and lower the elevator 3 times
Manual cleaning
. Additional brushing of the forceps elevator recess area using an
additional brush (MAJ-1888 brush). Additional flushing of forceps elevator recess area
. Additional raising and lowering the forceps elevator
Manual high level disinfection
. Additional manual flushing steps and increased flushing volume of
the endoscope channel and forceps recess area. Additional raising and lowering of the forceps elevator
Regards
Glenys
Glenys Harrington
Consultant
Infection Control Consultancy (ICC)
PO Box 5202
Middle Park
Victoria, 3206
Australia
M: +61 404 816 434
ABN 47533508426
Communication – New Reprocessing Instructions Validated
MedWatch logo
MedWatch – The FDA Safety Information and Adverse Event Reporting Program
Duodenoscope Model TJF-Q180V by Olympus: FDA Safety Communication – New
Reprocessing Instructions ValidatedEngineering, Patient
for the TJF-Q180V duodenoscope to replace those provided in the original
labeling. The FDA has reviewed these new reprocessing instructions and the
validation data as part of its ongoing review of the 510(k), and recommends
that any facilities that are using Olympus’ TJF-Q180V duodenoscope train
staff on the new instructions and implement them as soon as possible.disinfect or sterilize reusable devices. The FDA is closely monitoring the
possible association between reprocessed duodenoscopes and the transmission
of infectious agents, including multidrug-resistant bacterial infections
caused by Carbapenem-Resistant Enterobacteriaceae (CRE) such as Klebsiella
species and Escherichia coli. If not properly reprocessed, residual body
fluids and organic debris may remain in microscopic crevices of the device
following an attempted cleaning and high level disinfection. If these
residual fluids contain microbial contamination, subsequent patients may be
exposed to serious infections. The FDA’s investigation into the possible
association between inadequately reprocessed duodenoscopes and patient
infections, including the agency’s recommendations for health care
facilities, is more fully discussed in the following recent communications:
February 2015 Safety Communication
and FDA’s Updated Information for Healthcare Providers Regarding
Duodenoscopes issued March 4, 2015.facilities and other users of the TJF-Q180V outlining the new, validated
reprocessing instructions, and will soon be distributing revised user
manuals. Key changes have been made to the Precleaning, Manual Cleaning,
Manual High Level Disinfection reprocessing procedures for Olympus’
TJF-Q180V duodenoscope. Please see the FDA Safety Communication
for more details. In addition, FDA has the following recommendations
for facilities and staff that use and reprocess the Olympus TJF-Q180V:*Implement the new manual cleaning and high level disinfection
procedures for the Olympus TJF-Q180V duodenoscope in accordance with the
manufacturer’s reprocessing instructions.
*Train appropriate staff on Olympus’ new reprocessing instructions
and implement them as soon as possible.
*Contact Olympus directly with specific questions and concerns or to
schedule a site visit with their Endoscopy Support Specialists Technical
Assistance Center (TAC), 1-800-848-9024, option 1 Monday – Friday between
7AM EST – 8 PM EST.Healthcare professionals and patients are encouraged to report adverse
events or side effects related to the use of these products to the FDA’s
MedWatch Safety Information and Adverse Event Reporting Program:*Complete and submit the report Online: http://www.fda.gov/MedWatch/report
* Download form
or call 1-800-332-1088 to request a reporting form, then complete and
return to the address on the pre-addressed form, or submit by fax to
1-800-FDA-0178Read the MedWatch Safety Alert, inclusing links to the FDA Safety
Communication at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMed
icalProducts/ucm440098.htm_____
You are encouraged to report all serious adverse events and product quality
problems to FDA MedWatch at http://www.fda.gov/medwatch/report.htmFollow MedWatch on Twitter
twitterUpdate your subscriptions, modify your e-mail address, or stop subscriptions
at any time on your Subscriber Preferences Page
. You will need to use your email address
to log in. If you have questions or problems with the subscription service,
please visit subscriberhelp.govdelivery.com
.This service is provided to you at no charge by U.S. Food
& Drug Administration (FDA).FDA
HHS_____
This email was sent to infexion@ozemail.com.au using GovDelivery, on behalf
of: U.S. Food & Drug Administration (FDA) . 10903 New Hampshire Ave . Silver
Spring, MD 20993 . 800-439-1420Powered by GovDelivery
MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO
NOT REPRESENT THE OPINION OF ACIPC.The use of trade/product/commercial brand names through the list is
discouraged by ACIPC. If you wish to discuss specific reference to products
or services by brand or commercial names, please do this outside the list.Archive of all messages are available at http://aicalist.org.au/archives –
registration and login required.Replies to this message will be directed back to the list. To create a new
message send an email to aicalist@aicalist.org.auTo send a message to the list administrator send an email to
aicalist-request@aicalist.org.au.You can unsubscribe from this list be sending ‘signoff aicalist’ (without
the quotes) to listserv@aicalist.org.auMESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.
The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.
Archive of all messages are available at http://aicalist.org.au/archives – registration and login required.
Replies to this message will be directed back to the list. To create a new message send an email to aicalist@aicalist.org.au
To send a message to the list administrator send an email to aicalist-request@aicalist.org.au.
You can unsubscribe from this list be sending ‘signoff aicalist’ (without the quotes) to listserv@aicalist.org.au
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