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Responding to FDA's Guidelines on Reusable Medical Devices

Who needs reprocessing? A camera the size of a grain of salt may enable the development of disposable endoscopes. (Image: Fraunhofer Institute)

Last week, FDA announced that it would be taking steps to improve design and cleaning instructions for reprocessing reusable medical devices with the intention of reducing the risk of spreading infection between patients. And while the onus of reprocessing reusable medical devices such as endoscopes is on healthcare facilities, medical device manufacturers are responsible for clear reprocessing instructions and optimizing device design accordingly. So, what does all this mean for you?

First off, it means that manufacturers of reusable medical devices should make sure that their products, when appropriate, are engineered with the optimal design features identified by FDA for facilitating proper reprocessing. Features highlighted by the agency include smooth inner surfaces of devices with long, narrow interior channels; clear identification of components that should be discarded after use; and designs that take into account fluid flow through a reusable device.

In addition to heeding such recommendations by FDA, manufacturers of endoscopes, in particular, may want to begin considering an entirely new approach to device design, however.  Between January 1, 2007, and May 11, 2010, for example, there were 80 reports of inadequate reprocessing of endoscopes and 28 reports of infection that may have resulted from inadequate reprocessing, according to FDA. Although these numbers aren't catastrophic and the risks do not outweigh the benefits, there may be a design solution to avoid such reprocessing issues altogether: the disposable endoscope.

Just this week, Israeli medical device manufacturer Medigus announced that it has developed the world's smallest video camera for use in endoscope applications. Furthermore, the Fraunhofer Institute unveiled a microcamera the size of a grain of salt last month. Because of their small size and relatively inexpensive manufacturing costs, these microminiature components hold significant promise for enabling the development of disposable endoscopes in the foreseeable future.

In the meantime, manufacturers of reusable devices need to keep tabs on FDA's actions in relation to reprocessing guidelines. The agency will sponsor a public workshop in June on the subject and collaborate with representatives from industry, other agencies, and healthcare providers on future device designs and scientific advances in reprocessing. It also plans to issue a draft guidance to medical device manufacturers that will establish how to scientifically validate the reprocessing instructions that are included in device labeling.

Aside from monitoring FDA's actions, reusable device manufacturers should start planning for the future and make sure that designs are optimized to accommodate reprocessing. It also can't hurt to play the 'what if...' game in terms of creating disposable versions of reusable devices. After all, technology is advancing at a rapid clip, and you never know what scientists will innovate next. --Shana Leonard

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