Olympus recalls voluntarily duodenoscopies that is linked to several fatal infectionsJason Furze (Author) Published Date : Jan 20, 2016 00:38 IST
Following a report by the Senate Committee that Olympus was aware of a deadly flaw in the design of its TJF-Q 180V or the device known as duodenoscopy , the company is in the process of voluntary recall of the device. The flaw in the design of the device has also been linked to the death of some patients. The flaw in the design made it nearly impossible for the device to disinfect between different patients and allegedly lead to the death of patients on account of deadly infections contracted from the device. According to a report by the Los Angeles Times, the device accounts for about 85% of scopes that are sold across the United States.
On January 15, the US FDA had cleared the device in view of modifications in design and new labelling intended to help reduce the risk of bacterial infections. An FDA announcement also said that the company is in the process of voluntarily recalling the original model and carry out necessary changes as soon as possible. In another statement, William Maisel, deputy director and chief scientist at the FDA s centre for Radiological Health and Devices said that the new design of the device and a new program of annual inspection were aimed at reducing the risk of fluid leakage to the elevator channel, that can, in turn, reduce exposure of the patient to bacteria and similar potential infections. The model presently under the lens initially came under the FDA scanner in 2014 March when the company was notified by FDA that the closed elevator channel model was open in the earlier models and required the company to submit a premarket notification. The company was notified by the FDA through a letter that these design changes produced serious health implications as safe use of the device was impacted. To resolve this issue, the company reverted to a mechanism design. According to the FDA, the mechanism design is substantially equivalent to the mechanisms earlier approved and contained in the duodenoscopes from the company that had been approved by FDA previously.
FDA has also directed that health care facilities can continue using the Olympus device, but the reprocessing instructions from the manufacturer should be meticulously followed.
Olympus recalls voluntarily duodenoscopies that is linked to several fatal infections