“Endoscopic retrograde cholangiopancreatography (ERCP) procedures for patients should not be cancelled.” This is according to the US Food and Drug Administration in the US. The Agency confirmed having received many enquiries from the health workers due to what they termed as lack of 510 (k) clearance of a particular model duodenoscope which has been manufactured by Olympus (the TJF-Q180V). The drug has been linked to a series of multi – drug resistance bacterial infections. Besides two deaths have been reported at UCLA hospital hence the concern to cancel its administration by the health providers.
However FDA has come out clearly to defend the cancellation. The Agency argues that the infections being associated with duodenoscope are only occurring in those patients whose procedures have been done with duodenoscope from the three manufacturers. The Agency confirms that US alone carries out roughly 500,000 procedures per year. Hence its main concern is that once this device is removed from the market what will be available will not be sufficient enough to meet clinical demands of the US population.
That said, it is clear that the Agency will not be taking any action on Olympus regardless of the fact that the medical device they are marketing is way below the FDA standards. There are benefits associated with ERCP procedures. Henceinstead of withdrawing the device from the market, the FDA has pointed out the following procedures that the health providers who are planning to undertake ERCP should imply: –
- To clean the device thoroughly and according to the manufactures instructions.
- Highlighting to the patients what they should expect as a result of the procedures. This includes the symptoms they should look out for that would trigger more follow up the likes of vomiting, nausea, breathing and swallowing problems, abdominal pains and chest pain among others.
- Include a program for reprocessing duodenoscopes and which should be comprehensive.
- Methodically clean and disinfect any duodenoscopes that could be suspected to have an association with a patient’s infection.