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#41222 09/10/09 9:51 AM
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Super Hero
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Super Hero
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I think it's time to pull together some earlier threads under a fresh banner. Following debate (in those earlier threads), some consensus has emerged regarding a need to afford techs some flexibility in setting (and adjusting) PM intervals.

Briefly, the idea is to consider adjusting PM intervals (lengthening usually, but can also be reducing) in accordance with risk criteria (the factors for which need careful consideration) and the passage of time (with experience of the actual usage of the equipment, its continuing condition, reliability and failure patterns, and other such indications).

The aim being efficiency in the best use of technical man-power (limited, in every case that I have ever come across), addressing all equipment on inventory, with emphasis on patient safety, whilst still encompassing the well-tried principles of equipment maintenance, in all its guises.

Some of those earlier threads were "left hanging", as it were. So let's see if we can draw things to a tidy conclusion this time! These are the earlier threads:-

1) One
2) Two
3) Three
4) Four
5) Five
6) Six

... OK, let's continue from here ... ! smile


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Super Hero
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I hope I may be forgiven for quoting from my own post, but it seems to belong here (at this juncture):-

Originally Posted By: Geoff Hannis
OK, here's some of the background:-

Although Larry Fennigkoh and Brigid Smith (F&S) may not be exactly household names to many in the UK, they were pioneers (writing in a paper published way back in 1989) of an approach that used a numerical algorithm to determine which medical equipment should be included in an equipment management system.

The F&S algorithm scores equipment on three factors:-

1) Function (2 to 10)
2) Risk (1 to 5)
3) Required maintenance (1 to 5)

The sum of these scores yields an "equipment management" (EM) number. Equipment with an EM of 12 or above are included in the equipment maintenance programme.

The F&S algorithm (and its many derivatives) have been incorporated into computerized maintenance systems and adopted by various healthcare organizations.

In 1996 Mike Capuano and Steve Koritko (C&K) expanded upon the original F&S idea. To my mind, the big step forward made by the C&K model was the possibility of automatic extension (or reduction) of the PM interval according to specific criteria.

In 2000 Binseng Wang and Alan Levenson (W&L) recommended a modification to the F&S model to add a "mission criticality" score to reflect the importance of a particular device to the overall mission of the healthcare organization. I find this a bit OTT, myself.

Twenty years on, some now question the F&S model. For instance, it is possible for a device with established maintenance requirements to be excluded simply because it has a low score. And some versions of the algorithm use the total score to determine not only inclusion but also frequency of maintenance (which are fundamentally different concepts, and should be decided on different criteria).

In 2001 Malcolm Ridgway proposed a different approach:- one in which medical devices to be included (in the maintenance programme) were those that are "critical devices" (in the sense that they have significant potential to cause injury if they do not function correctly) and are "maintenance sensitive" (in that they have significant potential to malfunction if not provided with adequate PM). Note that Ridgway excludes non-critical devices, and any for which there is no evidence of benefit from PM.

See also Paul's response. Any chance of some more comments from you (Paul) regarding this topic? How about some links? smile

Note that "Ridgway excludes non-critical devices, and any for which there is no evidence of benefit from PM". Here Malcolm and I must disagree, I'm afraid. Or, put another way, I have yet to be convinced, especially on the first point. And surely the second point can be challenged on what exactly is meant by "evidence" in this context. For instance, it could simply mean that the PM procedure, and its interval, is in fact "spot-on"!

I have always been very much of the old-school "go to the department and PM everything you find" approach! It is (was) known as the "Sweep Method", I believe, but probably does not get used much these days! frown

Finally (for now, at least) here's some more background reading.


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Before someone comes on here again insisting that Risk-based PM is all nonsense, and that everyone is obliged to blindly follow whatever PM interval (and procedure) the manufacturer recommends in each case, here is "chapter and verse" from DB-2006(05) (which, as far as I am aware, contains the current equipment management "guidelines" issued by the MHRA ... that is, an Agency of British government):-

Under Section 8.4 (Planned Preventive Maintenance). Note against Service Interval ...

Quote:
Should be based on the manufacturer’s recommendation, taking into account how much the equipment will be used.

So doesn't that simple phrase "taking into account how much the equipment will be used" open the door to lengthening the PM interval beyond that recommended by the manufacturer, as long as agreed conditions are met, and documented? smile

By the way (and in my opinion) DB-2006(05) contains a whole load of common-sense, well-reasoned "policy statements"* (and not before time, I might add), and I hope and assume that, by now, all government hospitals and others responsible for maintenance and support of medical equipment follow its guidance. To my mind, the only trouble with "guidelines" like these is that (just like the Highway Code) they are not actually made compulsory by Law! frown

* Like, for example, permitting spare parts to be sourced from alternative suppliers as long as they are to "the same specification" and that sourcing decisions are properly "risk assessed, costed and documented". Happily, it also reminds us of the legal basis for carrying out electrical safety testing (EWR under the HASAWA). But unfortunately, it is a bit vague about just when (and to which Standard) these should actually be carried out. Let's hope that the next issue of such "guidelines" is able to endorse IEC-62353, and be done with it!


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Here's some more related posts from the hallowed archives, especially with regards to Risk Criteria and Scoring.

Litera scripta manet! smile


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Super Hero
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And here's yet another "blast from the past" which touches on PM intervals. It has been kindly pointed out to me, and I note that it originates from well before I first joined in the fun here on the forum (back in the Good Old Days, then)!

The guys made some interesting points. Has anything changed, nine years on? smile


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Hello Geoff,

Another link in the same vein:

Reliability Centred Maintenance (RCM)
After being created by the commercial aviation industry, RCM was adopted by the U.S. military (beginning in the mid-1970s) and by the U.S. commercial nuclear power industry (in the 1980s). It began to enter other commercial industries and fields in the early 1990s.
see: https://www.ebme.co.uk/arts/rcm/index.htm
smile


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Yes John ... I know you are a "true believer" in the concept.

Do you have anything to add to the current thread? Have you, for instance, had any joy in implementing RCM over the last few years? And how to sell the thing, and convince "the Management" of the need for it? smile


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Good topic that requires study & reflection, neither of which I have time for at the moment so forgive me if this article has already been addressed. In the Health Estate Journal May 2006 Vol 60 No 5 Paul Robbins wrote about managing risk in device engineering - here's a link to it but the web online article doesn't have the figures & charts so try & get your hands on the original - http://www.healthestatejournal.com/Story.aspx?Story=1063.

Identifying, categorising and scoring risk is addressed and it is topical for those of us in the NHS because the regime of payments by results should give priority to mission critical devices and systems.

Must try and catch up.

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That's a great link, Paul, and thanks for adding it to the pile, as it were. I for one hadn't seen that before, and I look forward to going through it later.

Many of us are aware that a few (perhaps more) people "out there" are actively pursuing the kind of practices we like to talk about here, but we don't always get to hear much about what they are up to, unfortunately.

I may as well make this little plug:- contributions (that is, posts) to this forum cost nothing (except a few minutes - usually - of anyone's time). But the missive then gets a viewing, and an airing, all across the world. It also gets published, shall we say, instantly, and presents itself (literally in open forum) for immediate comment, feedback, and ... er, rebuttal.

A form of true democracy, then, in the proper biomed style (that is, peer review ... usually with a bit of banter thrown in).

On the other hand, "learned societies and institutes* ... " (I'll leave you all to draw your own conclusions). smile

* Needless to say (and as mentioned before) I personally ditched all that stuff (and all those subscriptions) many years ago. I can't see what's wrong with the free exchange of information, as practised by many on this forum.

After-note:- having just gone through Paul Robbins' excellent paper ... yes, it would be nice to see the illustrations. Especially Figure 7 (if nothing else). Another thought that I picked up was this one (to paraphrase):-

Perhaps it's the user that needs maintenance, rather than the device! Yes, indeed. And this is, I would suggest, the perspective from which to look at hospital-based equipment maintenance, anyway. That is, from the point of view of the needs of the user, and are these needs being met?


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Dave’s basic principle: That no reduction of safety or reliability be done (much like the Hippocratic Oath really!) but that the requirement for assessment, testing and preventative maintenance of equipment be assessed on the actual, evidence based, and provable requirement for that testing/assessment/maintenance. That, the OEMs requirements are NOT the bottom line but, rather, the application of a full risk analysis can better provide an effective system of PM schedules.

I would hope that those who are going to enter into this conversation have a understanding of the principles of risk management and/or have read and understood the various standards that apply (here in Oz that’s AS/NZS 4360:2004 but in other parts of the world other, but similar will apply, me thinks.) The principle is the same no matter what.

I would have to say at this point that I am deeply indebted to the folk at The Ottawa Hospital for their generosity in sharing their work on risk based systems with me and, I hope they don’t mind, via this forum with the world.

First, I would draw your attention to the file attached (Leo-Risk Based PM Scheduling.pdf). It is through this that I first became aware of the work in Canada. This gives a good general impression of the work that was done there. Second, have a look at the detail of the Risk Form shown. This shows the basic format of the assessment as done. (assesment form.pdf).

If we run an example of this (and for this I will use a Datex Tuffsat Spo2 monitor) then the results pan out as..

Function rating: Patient monitoring device: 5
Consiquence rating: mistreatment 3
Maintenance rating: None 0
Protection rating: Yes (3), No (6) 6
Failure rating: none 0
Use & availability daily 6

Total score 20

This score would then place the Tuffsat into a once per year PM category.

Now, I have to say that I think that this is an incorrect assessment and as such I would (and intend to) modify the scoring system. My reasoning is that, although this is a patient monitoring device it is not used in high acuity monitoring but rather in low risk ward type environments. This should reduce the score under the “Function” section. Similarly, under the “Consequence” section, in theory a false (low) reading could lead to treatment of a condition that is not real but in the ward type environments that this devise is used is that actually the likely outcome? I think not, so again, perhaps some modification would be required to lower the risk score here.

I have intentionally used the Tuffsat as the example because my feeling is that such a device need never be tested (I can hear the gasps of disbelief from half a world away). It is a hand held, battery operated device. It has no calibration or adjustment. In short, it works or it does not. The only problems I have seen are of the probe or the complete shutdown of the unit. What do we achieve by doing an annual PM? Answer, nothing. I would put this type of device into a “check function only on repair” category.

“But what about performance verification?” I hear some cry, to which I would answer, why? what’s the point? A performance verification is valid only at the time it is done and becomes invalid as soon as the device is moved/used/etc. If we are to provide a true verification then it would need to be done before every use. To do so once per year is, I think, a complete waste of time.

At the other end of the scale of course are those critical devices such as ventilators, anaesthetic machines, defibs, etc. A quick check on an ICU vent, for me, scores a 46 (that’s 12,12,12,0,6,4 going down the check sheet). This quite rightly shows a requirement of 6 monthly PM. I have no argument with this requirement.

So, pros and cons……

Pro..

A risk based approach to PM can provide for continuing levels of equipment reliability and safety while reducing the resource needed to support this level of “up time”.

We are all aware of the increasing levels of equipment use within the healthcare sector but are also aware that there has not necessarily been an increase in the funding or staff levels in BME departments to match it. Risk based PM provides a way to use the available resources in a more efficient way, focusing the available resources where they are needed and away from areas they are not.

Con..

Risk based PM may actually reduce the resource requirement to such an extent that some staff are no longer required and budgets may be reduced or the level of income to the department will drop.

Well, yes, potentially, but is that a bad thing? We all, both in the public and private sectors, have a responsibility to those who fund us to provide best value. Risk based PM provides a channel by which this can be done. To take a Sir Humphrey Appleby like attitude of “the more staff we have the more important we are” is not reasonable in today’s environment. The tax payer (and that is you after all) does not have endlessly deep pockets. We all need to look for efficiencies in what we do.

Couple of other observations.

I took the form shown here down to one of our client hospitals to try them out and sat down with the nurse unit manager of ICU/CCU. I found that we had somewhat differing views in some areas. One of the examples used was the 12 lead ECG machine that lives in the unit. It was clear from the discussions that the NUM that she viewed the function of that ECG machine as absolutely critical to the running of the clinical unit. I did not share this view. This is not the only ECG machine available (there was another in a ward just round the corner) and the monitoring system used in the unit had 12 lead capabilities as well. To my way of thinking, these were viable alternatives in the event of a breakdown she however saw only that clinical practice required that a conventional ECG machine must be available in the unit at all times. My point here is two fold. First, some measure of the clinical practices should/needs to be taken into account when doing a risk analysis and secondly that there may well be a difference of view between biomedical and clinical groups. This is an issue that would need to be overcome for such a process to be put in place and accepted.

Some months back, I was talking to my manager about risk based PM and it turned out that he had also been looking at this as well but from a somewhat different angle. Being something of a wiz at getting info out of databases he had found that out of the thousands of PM tests done on infusion pumps over the last few years only three “failures” had been found as a result of that PM testing (I will try to get the exact figures from him again and post when I have them). This means that from a patient safety point of view a huge percentage of the tests done were, in effect, a waste of time and effort. Now it could be argued that the 3 devices that were picked up did not go on to cause a patient incident but given the numbers of pumps that do fail “in-use” and the comparatively rare incidence of serious incident arising from those failures I do not think this is a particularly strong argument.

Finally (Thank God I hear you cry), does PM really reduce breakdowns? In some device types I would certainly agree that it does and in these cases I would agree with the work being done but across the board, I think not. If we take the rational approach allowed by a risk based system we can keep our safety standards a high as ever but remove or at least reduce the amount of pointless effort that we seem to spend so much time on.

Attached Images
Leo-Risk Based PM Scheduling.pdf (651.56 KB, 1512 downloads)
assesment form.pdf (11.66 KB, 952 downloads)

Thoughts and information provided on this forum are mine and mine alone and do not necessarily reflect the policy of NSW Health. They may also be complete bollocks!!
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