Pentax Medical is voluntarily recalling all ED-3490TK video duodenoscopes in order to replace the forceps elevator mechanism, O-rings, and the distal end covering and to update the operation manual to recommend annual maintenance, the US Food and Drug Administration (FDA) and Pentax have announced.
The design changes are intended to reduce the potential for leakage of patient fluids into the closed elevator channel and under the distal cap. In addition, a periodic duodenoscope inspection process is being implemented for the forceps elevator mechanism.
On February 7, the FDA cleared the updated design and labeling changes for the ED-3490TK, and Pentax Medical sent a letter to customers informing them of the recall, corrective action, and updated operation manual, which is included with the letter.
The customer letter also includes a field correction response form that customers should complete and return to the company. Pentax will then contact customers to arrange the return of the ED-3490TK scopes to complete the design changes.
The complex design of duodenoscopes may hinder effective reprocessing, and the FDA has been working with duodenoscope manufacturers to modify and validate their reprocessing instructions to enhance safety and ensure that the reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes.
In February 2016, Pentax issued updated instructions for manual reprocessing of the ED-3490TK duodenoscope to replace those provided in the original device labeling. Subsequently, the company provided the FDA with additional information related to a potential risk associated with the design and manufacturing of the ED-3490K duodenoscope, which prompted the FDA to issue an updated safety notice in January 2017.
In the notice, the FDA said cracks and gaps in the adhesive that seals the device’s distal cap to its distal tip can occur, which can lead to microbial and fluid ingress.
The FDA said today’s action does not alter the updated reprocessing instructions for the Pentax ED-3490TK duodenoscope issued in February 2016.
The FDA is continuing to monitor the association between reprocessed endoscopes and the transmission of infectious agents. The agency encourages healthcare providers to report adverse events or side effects related to the use of these products to the MedWatch, the FDA’s safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at http://ift.tt/KHxbBZ; with postage-paid FDA form 3500, available at http://ift.tt/1412xto; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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