August 10, 2021 | | Comments 0
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Processing processes: Keeping everything in front of you…

I’m thinking that there’s probably a fairly limited number of you folks for whom durable medical equipment (DME) is part of your “span of control,” though, as I think about it, there may be some confluences with the DME world for those of you who provide home care services to your patients. As a going concern, this doesn’t necessarily come up on my radar a lot, but sometimes the real world provides some examples of process gaps (I won’t go so far as to call them failures—I don’t have enough data to make that assertion just yet) that might be instructive.

There’s a member of my household who uses a device to provide breathing assistance while sleeping and has for quite some time. It would seem that the device in use is the subject of a recall notice from the Food & Drug Administration (FDA), which we learned about from a family friend. After doing some research on the web (because there had been no official notification received in this regard), as one is wont to do under such circumstances, it turned out that the device in question, which is indeed involved in the recall, had never been registered with the manufacturer. Once the registration of the device was completed, the recall notice showed up around a week later. We’re still digging into the particulars, but it would seem that the DME supplier did not include registering the device as part of their “service” nor was there an effective communication as to the need for the registration to be completed within the household. I use the descriptor “effective” because it is possible that the communication was provided (I suspect that that will be the “defense” rendered by the DME company), but was insufficient to ensure that the device was registered with the manufacturer. I suspect that in this instance, like in many others, the communication was designed more towards the knowledge base of the person or persons providing the content and not so much the knowledge base of the person (or persons) receiving the information.

I can “see” what probably happened with this whole thing, but I keep coming back to the thought that transferring the responsibility of registration, etc., to the end users seems to be a recipe for all sorts of problems. There are certainly times when the management of a device or process is most powerfully administered by the end users (for instance, weekly eyewash station checks), but in the absence of a true orientation and ongoing education process for those end users, some of the administration really should be in the hands of the most knowledgeable party/parties. That said, if you have folks at home using breathing assistance devices, it might be worth checking out the recall if you’ve not yet encountered it. Also, you might find it of value to bookmark the FDA’s safety communications page; it’s well-organized and has a lot of useful information. Again, this may not apply professionally to everyone, but it never hurts to consider process gaps as they may well be instructive in other areas.

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Filed Under: Hospital safety


Steve MacArthur About the Author: Steve MacArthur is a safety consultant with The Greeley Company in Danvers, Mass. He brings more than 30 years of healthcare management and consulting experience to his work with hospitals, physician offices, and ambulatory care facilities across the country. He is the author of HCPro's Hospital Safety Director's Handbook and is contributing editor for Briefings on Hospital Safety. Contact Steve at

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