Following on from an earlier thread ...

It seems that (in the USA) the Centers for Medicare and Medicaid Services (or CMS, for short) has issued an edict (.pdf) which seems to require that (in order to receive Medicare and Medicaid payments) hospitals need to adhere strictly to manufacturer recommendations for inspecting and maintaining critical care and imaging equipment.

This statement has apparently drawn considerable comment and concern in the States, as it contradicts the more flexible stance recently taken by the Joint Commission* (which has allowed hospitals to use their experience to determine how often medical devices should be inspected). This flexibility has been widely supported in the literature and by biomeds in general (and, I dare say, by certain members of this forum)!

Meanwhile both ASHE and AAMI have been drawn into the debate (as indeed has ECRI) ... so hopefully we shall at last be seeing some "final" words of wisdom on this issue (in the US, at least).

But as it stands, the Bottom Line of the CMS requirement is:- PM must follow the manufacturer’s schedule on critical equipment, and some form of evidence-based scheduling on non-critical devices.

To my mind, that sounds like good policy ... especially the second part.

* Joint Commission on Accreditation of Healthcare Organizations

Just in case anyone was wondering:-

AAMI
ASHE
ECRI
JCAHO

Looking again at what CMS is saying, they make it very clear that even where revised scheduling (of PM) is permitted, it the interval - not the procedure itself - which may be adjusted.

That is (and I quote):- "alternative equipment maintenance methods are not permitted".

And that:- "hospitals must continue to follow the manufacturer's recommended techniques for maintaining equipment, even if the hospitals alter the frequency of maintenance activities".

But OK ... PM intervals for "non-critical" [definition required] equipment may be varied (lengthened, presumably), just as long as such a change is supported (justified) by "evidence".

What form does this "evidence" take I wonder?

That is:- how do we satisfy the Managers, the Bean Counters, Lawyers and Miscellaneous Suits ... et al (and anyone else who routinely stands in the way of progress in general)?

Meanwhile, here is some more on EBM (Evidence-Based Maintenance) (.pdf).

This is what CMS says:-


Straight away I can see that we need to agree on what is meant by "adversely affect"!

Why employ intellegent, knowledgeable Clinical Engineers when you can just have a monkey to follow the instructions given by the manufacturer? Or even put it on contract and save a wage?

And if the manufacturer says you have to replace a non-worn out part which you can only get from the OEM every time you look at it, you have to because the powers that be say so.........Money making on a plate!!!!!!!

Robert the cynic

Furthermore:-

1) Manufacturer's service recommendations are written well before equipment goes into service. In other words, they are simply an informed (hopefully) guess (and rarely revised following years of in-service experience)!

2) How many times have we come across equipment of similar type, but from different manufacturers ... only to find service recommendations for one being well over the top, the other "hard to find"?

3) Surely it is clear that the medical equipment scene is driven by the manufacturers ... and not the biomeds ... and that the "Regulatory Bodies" are clearly on the side of the manufacturers (aka, CYA and taking the easy line of least resistance).

4) This sort of thing is yet another reason why biomeds need to be ... er, assertive and keep fighting the gougers!

How can either the manufacturer (or, for that matter, the Regulator) know "what is best" at any individual hospital or clinic? At best, the manufacturer's recommendations should be viewed as simply a basis (or guide) to locally developed procedures (whether they be "less", or "more").

So ... beat them at their own game, and present the evidence for Evidence-Based PM!

And how would I go about that? For starters (and as I have said before) I would propose (as candidates for lengthening PM intervals) all equipment that didn't need a repair [definition required] at all of the previous three (say) PM visits.

Geoff ,
I can only speak about the manufacturers I have worked for and the service side of their business was not deemed a profit generating entity.

My experience has been is that there are small number people ( in companies and hospitals ) who , at many levels , manage to sell the “ what if this goes wrong “ or “ this could break if …!” and before you know it there is a policy or a standard , most of us are powerless to address it ( largely because biomeds in general are a fragmented group) and then we all stuck with it .

Biomeds can be their own worst enemy, the cost of a Biomed Department in hospital is not big expense – relative to the cost of running a ICU Bed or a ED resus cubicle it very small but we all continue to tackle the issue of cost as our contribution to helping the hospital, now I’m not saying don’t save money but that’s not the focus of the clinical staff when they treating a patient.

That link you gave us to the Binseng PPT highlights this [some more on EBM (Evidence-Based Maintenance http://ohiocea.files.wordpress.com/2011/03/wang-huffman-evidence-based-maintenance.pdf ] ( in my opinion ) – if you look at slides 42 to 45 ( Defibs ;PCAs;Vital Signs ;Blanket Warmers ) - NPF – No Problem Found was by far the most pronounced issue there – and I would think this would be the issue of discussion more so than any of the other issues , however that point seems to be trivialized – but that’s the issue which cost the hospital the most in direct costs ( clinical staff time ) and when things go wrong there is the human cost ( the issue closest to the clinicians heart hence using a $3000 catheter as single use item doesn’t bat an eye lid )

I have posted a suggestion on the NAMDET site [ http://www.namdet.org/da/115909 ( Intro The Clinical Equip……..) ] but if biomeds , who are best positioned to address the NPF issue , embraced this as a issue via the system ( using safety & quality and consistently measuring NPF as a reportable metric ) then how often you do or have to service a device almost becomes a non issue .

The performance of equipment fails as a result of incorrect use far more than it does from a engineering / technical perspective – and it’s not a dig at anyone, we all make mistakes – it’s a patients safety thing , the technology gap / issue is getting larger .

The real issue is that clinical staff are seldom told of these “user issues” [they not consistently report and measured ] and so users tend to do the same thing over and over ( and hence the same issue come up all the time) . Even worse is when high profile clinicians are involved, not only can they cause the most damage as they tend to do the most difficult cases so if ever something was going to go wrong , that’s when it does . And we all know the reporting of these incidences is dismal.
It’s a bit long – sorry

Enjoy the weekend , Cheers George

Weekend? Did I sleep too long last night (or better still, wake up in the Magic Kingdom)? I wish!

Thanks for that input, George (and long is OK ... by me, at least). And surely all that effort deserves a plug (it's a nice approach)!

I'll quickly take your paragraphs one-by-one, if I may:-

1) Perhaps. But there have been many examples of gouging when it comes to selling parts!

2) Indeed. Sadly, we have more than our fair share of Jobsworths here in the UK.

3) Yes. Biomeds are generally Good Folk ... who often "try too hard" (to please, and all the rest). There has always been far too much focus on cost and/or "saving money". We should be looking at other ways of measuring and presenting the value of biomed services (as has been said on here over, and over again)! In short, biomed should be presented as a Quality Service (that is, one that meets the needs - in technical support terms - of the clinical users).

4) Yes. Agreed. "Finger trouble" = more training required! But at least the users there have (presumably) reported (what they believed to be) faults in order to have all those Work Orders raised:- I see that as a Big Positive.

5) Nice one. I recommend everyone to download that .pdf (and critique it if need be)! Meanwhile, can I précis it down here to that well known cry:- RTFM!

6) Yes. In my experience it has always been like that. It's always be easier to simply "blame the kit", and the present day "No Blame Culture" hardly helps. You know, "Lessons Shall Be Learned" and all that [censored]! On the other hand, safeguarding patient safety is what Biomed is all about.

7) As I may have mentioned before, sometimes (often?) biomeds need to be, shall we say, assertive - and never be afraid to Take the Bull by the Horns as and when required!

But what about Evidence-Based (and its close associate Risk-Based) PM, George ... do you go for that?

Sorry George, but I don't see what your're saying there.

PM intervals cannot become a "non-issue" if they are being mandated by Regulatory Bodies!

Meanwhile, NPF is often just another "fault code" in my experience (and therefore already "reportable" - potentially, at least). Such codes are a response to Work Orders or RFS (Requests for Service), surely (and not PM)?

I may be a bit dim (more tea required), but I can't see how that impacts on the PM interval - especially (as I keep banging on about) if the "Risk-Based Model" is applied.

As I have already said:-


But this applies to PM visits not Work Orders. And if it were to be applied to PM results, then an accumulation of NPF codes should serve to trigger an extension of the PM interval (in a Risk-Based, auto-adjusting system). In passing, note that it also works in reverse:- PM intervals could be shortened if so many consecutive PM's did require a repair (intervention, whatever is decided). What we are seeking is PM equilibrium - or if you like, the "Goldilocks Condition"!