The company developed the device as an alternative to reusable duodenoscopes, enabling the use of a new and sterile product for each procedure.
CooperVision, Inc. and Pentax of America won the agency approvals, respectively.
The agency wants healthcare facilities to start using duodenoscopes that do not require reprocessing but recognizes the transition will take time.
Minimally invasive surgical endoscopes can tackle both the challenges of cost as well as durability.
Strong evidence of proper cleaning and reprocessing that eliminates the spread of bacterial infections is still not there, and improvements are necessary, says Shuren.
As medical device costs continue to be a growing area of hospital expenditures, many hospitals control the savings through device reprocessing programs. The shift toward planned obsolescence is especially troubling given the financial challenges many hospitals face.
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Failure to comply with FDA’s wishes landed three companies warning letters.
The duodenoscope manufacturers didn’t comply with requirements to conduct postmarket surveillance studies assessing reprocessing effectiveness.
The company’s ED-3490TK duodenoscopes require replacement of the forceps elevator mechanism and other parts.