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Update - interim results from FDA surveillance studies
18 December 2018
The US Food & Drug Administration (FDA) published a safety update on 10 December 2018 to provide the interim results from its ongoing mandated postmarket surveillance studies. The studies were mandated after higher-than-expected contamination rates were identified in duodenoscopes after reprocessing.
The TGA advice is similar to that of the FDA in that healthcare facilities and staff who reprocess duodenoscopes are reminded of the importance of proper servicing and manual cleaning prior to disinfection or sterilisation.
The interim results for each duodenoscope manufacturer are available on the respective FDA 522 Postmarket Surveillance Studies web pages (Fujifilm, Pentax, and Olympus).
Duodenoscopes used in Endoscopic Retrograde Cholangiopancreatography
Safety advisory - potential issues with devices transmitting infections between patients
16 March 2015
The TGA is aware that the US Food and Drug Administration (FDA) has issued a safety communication regarding duodenoscopes used in Endoscopic Retrograde Cholangiopancreatography (ERCP).
ERCP is a technique combining endoscopy and fluoroscopy and it is used primarily to diagnose and treat conditions of the liver, pancreas and bile ducts.
Duodenoscopes are a type of endoscope specifically designed for use in ERCP. They are flexible tubes that are threaded through the mouth into the top of the small intestine (the duodenum). Duodenoscopes contain a light, a camera and a hollow channel that allows the injection of contrast dye or the insertion of instruments to obtain tissue samples for biopsy or to treat certain abnormalities.
The FDA statement highlights that the complex design of duodenoscopes makes them challenging to clean. Adverse event reports in the US indicate that these duodenoscopes may play a role in transmitting infections, particularly those caused by certain drug-resistant bacteria.
The TGA has not received any adverse event reports regarding duodenoscopes and transmission of infections in Australia.
The TGA is monitoring the issue and encourages reporting of all adverse events associated with duodenoscopes.
Information for consumers
If you have undergone a procedure using a duodenoscope and you are concerned about this issue, contact your general practitioner or surgeon for individual clinical assessment and advice.
Following ERCP, many patients may experience mild symptoms such as a sore throat or mild abdominal discomfort and this is normal. However, signs of an infection could include a fever or chills, or other indications of a more serious problem (such as chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools).
Information for all health professionals
Health professionals who are treating a patient who has undergone an ERCP procedure should be alert to this issue.
Health facilities that use duodenoscopes for ERCP procedures are advised to be alert to the added difficulties involved in cleaning these devices and to ensure appropriate education is in place for staff responsible for cleaning and sterilisation.
While the TGA has received no adverse event reports regarding duodenoscopes and infections, we have received reports of other issues associated with cleaning endoscopes. These issues were discussed in the September 2014 issue of Medical Devices Safety Update.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.