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The Reuse of Single-Use Medical Devices
Keeping their commitment to finalize
a Guidance document on the Reuse of Single-Use Medical Devices by
mid-summer, on August 2, 2000, the FDA published to the Federal
Register a document entitled, Enforcement Priorities
for Single-Use Devices Reprocessed by Third Parties and Hospitals. The
document is currently available only in PDF Format (requires free Adobe Acrobat Reader to
view).
The IAHCSMM’s
only agenda in the issue of reuse of single-use devices has
been concern for the safety of the patient and the delivery of quality
patient care. Since
the spring of 1999 when we presented our Position Statement at the AAMI/FDA Conference
on Reuse of Single-Use Devices, the IAHCSMM has walked the walk
and talked the talk on reuse. This has
taken us from providing comments on FDA draft documents, presenting
oral and written comments at FDA Public Meetings, to testifying
at a full Senate Committee meeting. We
have never changed our position; the IAHCSMM does not recommend
the practice of healthcare facilities reprocessing single-use devices
in their facilities. The IAHCSMM
encourages healthcare facilities choosing to reuse single-use
devices to contract the services of a third-party reprocessor,
registered with the FDA, and meeting the criteria of the hospital’s
multi-disciplinary committee on reuse.
We feel our committed involvement has made a difference. Because of our position, the IAHCSMM consistently supported the FDA Guidance of hospitals and third-party reprocessors in the matter of reuse. Now that the final Guidance document has been published, our activities will switch to assisting in the education and outreach effort the document will require. The IAHCSMM is on record as offering to help the FDA in any way possible, within our means, so we can expect to stay involved as enforcement is implemented. The FDA is currently developing an overview document of the new requirements that will be mailed to every hospital. We will keep our website up to date with new developments so our membership can stay informed.
We often feel that the work we do is underestimated and unappreciated. The issue of reuse of single-use medical devices has brought the importance of our function to the forefront. The fact that Larry Spears, Director, Enforcement II, of the Center for Devices and Radiological Health (CDRH) of the FDA would take the time and make the effort to be with us at our Fall conference to hear our comments and answer our questions should make us realize – OUR WORK IS IMPORTANT and WE CAN MAKE A DIFFERENCE!
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