In what may be regarded as a significant development that may slightly influence the market dynamics of reprocessed medical devices industry, the U.S. Food and Drug Administration has recently issued a safety alert on Pentax Medical’s ED-3490TK duodenoscopes. However, the reprocessing directives for this recently approved duodenoscopes have not changed since its last update in February 2016, as cited by reliable sources.
Apparently, the Japan headquartered reprocessed medical devices market giant has released a notification which aims to inform consumers of the company’s recall of its premium duodenoscopes, named as ED-3490TK, to replace the distal end cap, O-ring seal, and forceps elevator mechanism. Reportedly, the notice further states that the latest move is also intended to revise the Operation Manual in order to suggest annual maintenance activity.
Moreover, the design alterations proposed are targeted to lower the patient fluid leakages into under the duodenoscopes’ distal cap. According to Medscape, the FDA had approved Pentax Medical’s duodenoscopes that were initially designed to diagnose and treat bile and pancreatic duct disorders.
For the uninitiated, almost all major reprocessed medical devices market participants follow an intricate and comprehensive process to disinfect, sterilize, and clean the reusable medical devices. However, the multifaceted and convoluted design of duodenoscopes is said to hinder the effective reprocessing procedure of these devices. In order to tackle the aforementioned challenge, the FDA has been working hand in hand with duodenoscope manufacturers to improve the safety standards of these devices by modifying and validating their reprocessing instructions. Furthermore, the federal agency has prescribed a detailed list of actions on its Infections Associated with a Reprocessed Duodenoscopes webpage that has to be followed by all the device manufacturers.
Concurrently, the FDA has encouraged all the reprocessed medical devices market stakeholders including patients and healthcare providers to report harmful effects related to the utilization of these devices to its MedWatch Safety Information and Adverse Event Reporting Program.