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Posted By: Paul Hill Risk Register Of Equipment - 26/07/06 3:23 PM
Does anybody have a risk register of equipment based on a risk grading matrix (e.g consequence against likeilhood). If so can anybody share with me the criteria for how the grading was decided. I am particularly thinking of using this data for establishing PPM schedules.
Posted By: Joe Emmerson Re: Risk Register Of Equipment - 26/07/06 7:44 PM
We have not graded each individual item as such, however we have graded the 'Type' of device.

ECG - Recorder
ECG - Monitor
EEG - Recorder
Monitor - O2
Monitor - AA
Monitor - CO2
Module - Housing
Module - ECG
Module - NIBP
Syringe Driver
Volumetric Pump

There are currently 140? or so types of equipment listed for our Trust so it is relatively easy to apply a generic risk rating to all the equipment on the database.

Provided you can supply details from your database like MAKE, MODEL, TYPE you should be well away!

Each of these 'generic types' of equipment is risk rated with a C & L and rating = high/med/low

Once you marry up the listing of your database with the generic listing, the risk matrix will be created automamtically for you.

In addition, this style of matrix with a few modifications can be rolled out to the end users for their own departments training needs analysis (TNA) in order to fulfill the requirements of any external assesments on the Trust.

I'm sure that there is a actually an ISO standard concerned with risk assesment / management of medical devices (forgot the references), however its is generally accepted that certain groups of equipment are considered higher than others.

You are more than welcome to have of copy of my risk grading structure if you wish as it may save re-inventing the wheel or at least give you a good start.

As far as PPM Schedules go, if you have insufficient manpower to ensure that all devices are maintained then make sure you have a department risk register (business risk, not the trips and falls stuff) and pass this up the chain to ensure that those in positions above you are aware of the implications.

Never been a fan of risk centred maintenance in the normal context, however I do endorse careful planning and some exclusions from scheduled PPM. Take solid state tens units, battery powered dopplers, battery powered (non user changable) thermometers, etc. We dont schedule those and set them to 'As requested' on our database.

Batteries dont last a year, tens units either work, are still under the 3 year warranty, or are disposable (35), and scheduling a handleld doppler residing in someone's pocket doesent make sense.

Kind regards
Posted By: BK Re: Risk Register Of Equipment - 27/07/06 9:34 AM
Anyone else aware and know the reference to ISO standard concerned with risk assesment / management of medical devices ?
Posted By: Tracy Re: Risk Register Of Equipment - 27/07/06 2:09 PM
Is it not just the CNST standards, now called "NHSLA Risk Management Standards", that require risk assesments??

I would recommend reding the standards fully before embarking on a large piece of work, such as risk scoring all your devices, as sometimes it can be the translation of the standards that can be confusing.
Posted By: SAJEEV Re: Risk Register Of Equipment - 27/07/06 2:36 PM
Dear Paul,
Please check with ECRI

They have got a good data for your requirement
Posted By: Chris-H Re: Risk Register Of Equipment - 27/07/06 3:40 PM
Paul, generally speaking, your risk management/clinical risk department should have allready set in place an appropiate criteria for grading any medical device in terms of its associated risk.
Generally speaking, it may consist of a simple number process from 1-5 for example. each then sub divided into further categories, that may entail things like, "Near miss" "Death" "Clinical error" Injury to patient" and the likes. These are just a few thing I recall from memory, (getting old now).
Posted By: Tracy Re: Risk Register Of Equipment - 27/07/06 3:59 PM

go to the health care standards unit website, look in publications, HCC publication and find he report on risk registers, its called making it work.

The document has been wrote for risk managers, but if your having to do it then you can choose the matrix you want!!

I am happy to supply the vey poor matrix I used, but it was only for a level 1 assesment.

My advice is to question why this huge piece of work needs to be done, its not to fulfill a statement in one of your polices, that is above and beyond the risk managment standards?? Some of the highest level achieving trust have the smallest policies without making any wide statements about what they will do.

Posted By: sen nat Re: Risk Register Of Equipment - 29/07/06 1:00 PM
Hi Paul,

As somebody mentioned in the forum that ECRI would be the best bet to get a right and succinct answer. I have got some infoormation for you based on ECRI instructions.


Life support, key resuscitation, critical monitoring, energy emitting, and other devices whose failure or misuse is reasonably likely to seriously injure patients or staff.


Devices, including many diagnostic instruments, whose misuse, failure, or absence(out of service with no replacement available) would have a significant impact on patient care, but would not be likely to cause direct serious injury.


Devices whose failure or misuse is unlikely to result in serious consequences.


The following is a sample formula to meet requirements of evaluating equipment to include in the preventive maintenance program:


Life support - 10
Surgical and special care units - 9
Analytical Lab - 5
Non Patient related - 1


Patient Death - 5
Patient or operator injury - 4
No significant risk - 1


Extensive - 5
Above average - 4
Minimal - 1

In order to schedule your PPM, you may use the following formula:

EMC = Function + Risk + Maintenance Requirement


>= 16 Minimum of 2 PPM/year

12to15 Minimum of 1 PPM/year

11 or less No PPM or 1 PPM/year

The primary focus of the RISK BASED MAINTENANCE MANAGMENT PROGRAM is to reduce equipment hazards within our environment of care. This is accomplished through continuous monitoring and assessment of equipment related incidences, recall and alert notifications, and trends in equipment breakdown,. Evaluation of our effectiveness is accomplished through comparative analysis of current data from the automated maintenance management module that identifies trends/patterns of equipment failures and data from incident reports, recall and alert notifications. This analysis will serve as a basis for the Safety Committee's annual evaluation of the Maintenance Management Program's objectives, scope, perormance, and effectiveness.

Hope this helps.

Posted By: Ivor D. Re: Risk Register Of Equipment - 10/08/06 10:28 PM
An interesting topic and in my opinion all answers have validity.
I think that most (if not all) EBME departments have an appreciation of risk based maintenance and in effect have had to consider their deployment of manpower shewdly over a number of years.
Perhaps, like many professions, they may have all set out initially to cure all ills and carry out rigorous and complete testing of all devices which fall in to the realm of a technical services department.
Practically speaking, with the additional notches punched through their collective belts, these service providers have had to rationalise and prioritise their provision under the guidance of various standards and in particular risk management policies and guidelines and rightly so, perhaps.
There are exceptions though. What about the Physiotherapist who tested their TeNS unit by placing their hand across the conductive pads to verify functionality and progressively increased the amplitude until the they 'felt' the output but didn't realise that a faulty potentiometer could deliver maximum output gain immediatley and fell backwards under shock and hurt themselves to the extent of an enforced period of absence costing their Trust (and department services) in financial terms and themselves in personal terms a bewildering period away from their career.
Or perhaps a midwife, with a nominally noisy pocket doppler, the angst of an enquiry when they correctly found a foetal HR one day and the next a mother had to be told that she had to endure something which none of wish to discuss on the basis that perhaps natural causes had intervened, only to find that their equipment was 'out of compliance' because it was last technically checked quite some time ago.
Yes, clinically risk is correctly identified and yes these incidences may be rare, but they do occur.
We know what constraints there are and maybe some could be attributed to they way that budgents are devolved, managed or whatever but regardless of this, engineers still have the capability of improving the lot of others who lack the conception either through lack of training, skills, intuition or knowledge which they may posess.

Posted By: Geoff Hannis Re: Risk Register Of Equipment - 11/08/06 10:07 AM
Check out this previous thread . smile
Posted By: Paul Hill Re: Risk Register Of Equipment - 07/10/06 4:13 PM
Thanks Sadjeev ECRI website was very helpfull
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