FW: [ACIPC_Infexion_Connexion] Duodenoscopes used in Endoscopic Retrograde Cholangiopancreatography- Voluntary recall Olympus TJF-Q180V duodenoscopes

[Glenys Harrington]

Dear All,

Further to my previous postings on this topic:

Australia

. On 3/2/2016 Olympus Australia Pty Ltd and Olympus New Zealand Ltd
in consultation with the TGA issued an “Urgent Recall for Product Correction
for the TJF-Q180V duodenoscopes”

o The company will perform correction to the forceps elevator mechanism.

o The Operation and Reprocessing manuals have been updated.

o Customers are expected to commence us of the updated TJF-Q180V Operation
Manual and reprocessing Manual immediately.

USA

On February 19, 2016 the following FDA Safety Communication was released:

. PENTAX Validates Reprocessing Instructions for ED-3490TK Video

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm486772.htm

Video Duodenoscope include a more rigorous protocol for pre-cleaning, manual
cleaning, high-level disinfection and liquid chemical sterilization
procedures. In addition, updated instructions include additional text,
figures, cautions and warnings intended to clarify the validated
reprocessing procedure. The Agency believes that when followed, these
updated, validated reprocessing instructions demonstrate consistent and
reliable cleaning, high-level disinfection and sterilization of PENTAX’s
ED-3490TK’s Video Duodenoscope.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMed
icalProducts/ucm486887.htm

On February 19, 2016 PENTAX sent letter to health care facilities and other
users of the ED-3490TK Video Duodenoscope outlining the updated, validated
reprocessing instructions – see attached

I’m checking with the TGA to see if a letter with updated cleaning and
disinfection instructions will be sent to Australian users of the PENTAX’s
ED-3490TK’s Video Duodenoscope.

Feel free to share this information with your clinical products advisors,
colleagues in gastroenterology units, and risk managers.

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

Of Glenys Harrington
Retrograde Cholangiopancreatography- Voluntary recall Olympus TJF-Q180V
duodenoscopes

Dear All,

On 15/1/2016 the U.S. Food and Drug Administration cleared the Olympus
TJF-Q180V duodenoscopes for modifications to the device design and labelling
with the intention of reduce the risk of bacterial infections.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm481956.htm

Olympus America Inc (“OAI”) has posted a voluntary recall to replace the
forceps elevator mechanism in all TJF-Q180V duodenoscopes (a flexible
gastrointestinal endoscope used in procedures such as endoscopic retrograde
cholangiopancreatography (ERCP) – see attached letter

Staff in you gastroenterology units will be interested in this recall and
should contact the manufacturer for additional information.

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

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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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