Does anyone know of any standards or best practices for dealing with the safe handling of returned hospital mattresses (pressure relief)?

I appreciate any guidance or comments.

Thanks,

Danny

This is an unusual question for here so I'm going to bump the thread just in case anyone has thoughts or knowledge on this.

It doesn't look as if anyone here has any experience in, or ideas about, this area. Sorry.

I don't have any directly applicable experience, particularly under Health Canada rules. However, would it be reasonable to extrapolate from general guidelines pertaining to reprocessing of medical devices?

I don't know the extent to which US practice may be relevant to your application, but the FDA has guidances in this area.

Your application...a durable device, probably intended by the manufacturer for multiple patient uses...seems to be relatively simple in that regard, compared to situations such as reprocessing by a third party of devices that the original manufacturer designed, manufactured and marketed for single use.

The FDA's 1996 guidance "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities" includes a "request" that manufacturers of reusable medical devices "recommend at least one reprocessing method in their device labeling".

This guidance's preface states: "Under FDA labeling regulations, 21 CFR 801, a device must have adequate directions for use, which include instructions on preparing a device for use. Instructions on how to reprocess (i.e., clean, and disinfect or sterilize) a reusable device are important steps in preparing a device for the next patient."

As potential starting points for further searching, you could also investigate the endoscope-specific ASTM medical-device-reprocessing standards F1518:2000 (withdrawn 2009) and F1992:1999 (R2007). Perhaps there is additional standards activity that is relevant in this area but is not known to me.

Hi MIREGMGR,

I appreciate your comments and feedback.

Danny