EBME Forums Forums Management Professional Issues Risk Assessments

Hi All

I have been asked to perform risk assessment to all of the device types on site.

Anybody able to advise if there is anywhere I can get them from as I would have thought there would be some available online somewhere.

Any help would be appreciated

Did those (management, presumably) who assigned this task elaborate at all?

For instance ... what risks are to be addressed? Those to the patient? When ... during "normal use", or only under fault conditions?

Are the insurance folk involved? What about Public Liability and (or) risk to the hospital's reputation?

And, how about mitigations ... such as a properly conducted PM regime?

What level (depth) of input criteria is expected? Sometimes just a High, Medium or Low assignment of Risk suffices.

If you're not careful, having spent many days on the task, you may be rewarded with something like:- "That's not really what we had in mind ... can you go back and ... etc. etc."

In short, I would get the request clearly defined in writing before embarking upon it.

Another tip:- when going through your equipment types, don't forget that "location" (where and when it is used) may require a different Risk Score even amongst equipment of the same type (eg:- the simple electric suction pump, used in various locations, and under various levels of "crisis").

Meanwhile, if simple Risk Level Scores are all that are expected, I'm pretty sure we have touched on those a few times before. I don't have time to dig out the links right now, but will check back later. Hopefully by then someone else may have chipped in.

I know someone who is adamant that they can create a risk score combining user risk/operational risk/and downtime risk. They've been saying it for around 4 years now and i have yet to see this magic logic. By their way of thinking an Anaesthetic machine is a high risk device, my input that only a few selected trained operators of the machine make it less risky is not up for discussion......... As Geoff writes, get exactly what is wanted/needed before beginning.

@Iozzie:- If you already had (or have) a Risk-Centred Maintenance programme in place, then you could simply present that (the Risk Levels and what-have-you) to management bods as a fait accompli.

If not, now may well be the time to implement RCM. You know, in the spirit of "killing two birds with one stone".

@Dustcap:- Yes, there are a fair number of "academic biomeds" about (although mainly in the States, from what I've seen). Plenty of learned papers written, and so forth. In days gone by, I used to read them.

My recollection is that, regardless of the criteria being presented, and the (often tortuous) formulae being devised, the same equipment types generally always came out "on top" of the Risk Level heap. These tended to be the same equipment types that any first-year biomed tech would have offered up if questioned. In other words:-

Defibs, Infusion Devices, Ventilators and Dialysis Units were deemed "High Risk" whilst Electrosurgical Units and Anaesthesia Units (amongst others) were deemed "Medium". Most of what we used to call "Electromedical" equipment (including x-ray) were awarded "Low" risk status (and quite rightly, too).

In one well-known paper from yesteryear:-

Risk (Hazard) Score = Qty of Eqpt x Severity x Freq of Mishap

Where "Severity" is the only questionable factor, and was meant to indicate "severity - to the patient - in case of mishap".

In a typical hospital, the overall results would come out something like:-

Infusion Devices Qty 40 x Sev 10 x Freq 3 : Risk = 1200
Ventilators Qty 20 x Sev 10 x Freq 3 : Risk = 600
Defibrillators Qty 15 x Sev 10 x Freq 3 : Risk = 450
Monitoring Equipment Qty 50 x Sev 5 x Freq 1 : Risk = 250
Dialysis Units Qty 8 x Sev 10 x Freq 2 : Risk = 160
Electrosurgical Units Qty 8 x Sev 5 x Freq 2 : Risk = 120
Anaesthesia Units Qty 10 x Sev 5 x Freq 2 : Risk = 100
Baby Incubators Qty 20 x Sev 5 x Freq 1 : Risk = 100
Pacemakers Qty 4 x Sev 10 x Freq 2 : Risk = 80
Muscle Stimulators Qty 4 x Sev 5 x Freq 2 : Risk = 40
SW/MW Therapy Qty 4 x Sev 5 x Freq 2 : Risk = 40
Radiant Warmers Qty 6 x Sev 5 x Freq 1 : Risk = 30
X-Ray Equipment Qty 10 x Sev 1 x Freq 1 : Risk = 10
Ultrasound Therapy Qty 2 x Sev 1 x Freq 1 : Risk = 2

Notice the interesting (?) case where Monitoring Equipment (although of Low risk - low severity - individually) is bumped up the overall list by the quantities involved.

In terms of Severity, Infusion Devices (poisoning), Ventilators (asphyxia), Defibs (electrical) and Dialysis (poisoning) (and Pacemakers - easily overlooked) carry the highest scores.

You're right about Anaesthesia Units, of course: severity of outcome is mitigated against by the constant attention of a skilled and experience operator. Contrast this with how Infusion Devices are used, for example.

Not so sure about downtime. OK, it could be factored in ... but I would only afford small values to it; so it would be swamped by other factors - life support, maintenance requirements, frequency/likelihood/seriousness of mishap etc. - carrying far greater weight.

Downtime only really becomes a problem when considering "one-off" units (such as x-ray systems, and some lab equipment). But even then they can often be worked around by duplication of (or back-up) equipment, or co-operation with other hospitals.

In such cases, as the equipment is already "not working", the only risk to patients is delayed treatment.

So it's back to the drawing (black?) board, ivory tower ... wherever.

As I seemingly never tire of pointing out ... the key consideration is equipment condition (see my tag-line).

I realise it's "bad form" to quote oneself, but I thought it worthwhile to elaborate just a little by way of the following notes (if only to remind anyone embarking on assigning Risk Scores and (or) maintenance priorities to equipment that matters may not be as simple as they first appeared):-

Writing in a paper published in 1989 Larry Fennigkoh and Brigid Smith (F&S) pioneered an approach that used a numerical algorithm to determine which items of 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 yielded an "equipment management" (EM) number. Equipment with an EM of 12 or above was an indication that the item be included in the equipment maintenance programme. Note that this implied that some items need not be included in the 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 F&S idea. 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. To my mind, this was the "Big Idea"!

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 did not like that terminology, myself - it sounded "a bit corporate" to me. Call me old-fashioned, but I prefer the emphasis to be placed "from the patients' point of view".

From a distance of thirty years or more, some now question the F&S model. For instance (as mentioned above), 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).

Meanwhile, 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). Yes, this is (was) progress.

Ridgway excludes non-critical devices, and any for which there is no evidence of benefit from PM. This first point may be disputed by many, especially those who prefer to include all maintainable items in the PM schedule (that's me, then). And the second point can be challenged on what exactly is meant by "evidence" in such a context. For instance, it could simply mean that the PM procedure, and its interval, is "spot-on"!

No doubt the evolution has continued over the last twenty years or so, but I no longer follow such issues in any great depth. Perhaps someone else may be able to bring us up to date.

By the way, regarding the issue of "critical devices" ... I recall my boss at the time trying to push the idea of "life critical" equipment (I think that's what he called it) ... and that was 43 years ago! That one withered on the vine, mainly because our organisation required "inspections" of everything on a calendar basis anyway (mostly quarterly, but sometimes monthly) .... and after he had realised how difficult it was to answer the question:- "where do we draw the line" (what's the criteria)? I seem to recall lots of "philosophical debates", though (some things never change).