EBME Forums Forums Management Medical Equipment Management Managing Med Device involved with patient injury?

When an incident occurs that you are required to investigate I suggest:-

The investigation should be run by the Manager of the EBME Department.

Remove and isolate the equipment and any accessories that may have been attached at the time.

Do nothing until you have a copy of the incident form.

Try to speak to the people that were present at the time of the incident to get an idea of what actually happened – this in my experience is not necessarily what is written on the Incident Form; take a colleague as a witness to what is said.

Gather previous test/repair information.

If you have the requisite skills and knowledge test the item to the manufacturers specifications (obviously do not take the item apart nor adjust it in any way) record the results of these tests and print of any logs; ensure that you have a witness to all of this activity who will verify that you have carried out every step of these tests.

If there is another member of your Department with the requisite skills and knowledge get them to test the item, again to the manufacturers specifications but this time with an independent witness ie someone not from your Department and in extreme cases from outside of the organisation. If there is not another member of your Department available to carry out this stage of the process then where possible bring in a third party, if this is not possible you will need to use the manufacturer.

Write up a report (but do NOT express opinion) and send it to the risk manager/executive of the hospital of the above and a conclusion, if the equipment passes the tests then say so, if you find no problems then the standard response must be “that it works according to the manufacturers specifications”. Following remarks along the line of “this Consultant Surgeon needs retraining” should be avoided, but the suggestion that “we get someone in from the company to discuss the issue with the users” usually goes down okay.

Keep the equipment out of use until requested by senior hospital managment to return it.

Lee

Yep, spot on.

It looks like a nice procedure, but it could be challenged. For instance, what if (just suppose) the failure was due to the kit not being looked at (serviced) for five years? If the investigation is carried out by the Biomed Manager, how would you defend against possible accusations of "cover up"?


... and, if it doesn't? Say so as well, I guess.

And (just suppose) if "operator error" was indeed the root of the problem, who decides about that?

Or do these things get swept under the carpet, in order to protect reputations? If so, how can "lessons be learned"?

Dare I ask ... what about the patient?

Bottom line:- where is the Official Procedure (MHRA, or whatever)?

We receive a lot of 'incident' reports concerning misuse of medical equipment and it is amazing how much of this kit was 'endorsed' from the previous shift. The enduser admitting responsibity that would make me laugh.

Hey Neil, try the "quiet word, and the gentle touch" (take touch to mean figuratively speaking, of course). It usually (well, sometimes) worked for me. I think it's known as trust!

As we all know, hiding broken kit in cupboards doesn't help anybody. Especially the patient who next has need of it!

Your last line has hit the nail on the head Geoff!

In the event of a reported adverse incident, the device must be removed from use. Take note of any settings and seal the device. Notify the powers that be e.g. MHRA, Health Facilities Scotland etc and follow their advice. No tests should be performed without their permission, otherwise you could be accused of hiding things, no matter how honest you are.

Yes I have been involved with a fatality with a syringe driver.
Before I could complete the form, two CID men turned up under the direction of the procurator fiscal. They confiscated the syringe driver and took it up to IRIC who examined it thoroughly with the manufacturer. I was then asked to submit copies of the service records for that device. Fortunately no problem could be found, either with the device or the records.

So you have to be seen to be whiter than white.

In answer to Geoff’s points

In practise any procedure can be challenged.
Even worse what happens if the failure was caused by the EBME dept.?
You would hopefully show honesty and integrity and do it properly, once an incident is reported a copy goes to the Risk manager or similar (hopefully this is standard NHS practise).
The person investigating this matter will want previous test/repair information if you do not trust the EBME manager to run this investigation; can you trust him to supply damming information?

yes of course.

When given an item that you are told is faulty you can do allsorts of tests to verify its performance, but even if it works perfectly it is very difficult to guarantee more than “it worked okay when I tested the unit”. However I have investigated and criticised bad practice in the past (yes of Consultants).

As far as I know all incidents involving Medical Equipment are referred to us; they are investigated and action taken where necessary.

Out standing Patient Litigation against the NHS stands at approximately £12 billion so I don’t think that cover ups are prevalent.

A national policy would be good but the standard response always seams to be to make things much more complicated and expensive than needed.

Graham it could be worse you could be testing the equipment whilst the police are breathing down your neck. (At least it was a lady DI).

Lee

I'm pleased that someone has mentioned the Police. But what about the Coroner?

Also, note well the benefit in having proper equipment servicing records!

But the thought occurs:- if someone was really trying to have a go at biomed ... how could we deflect possible accusations of falsification (of service records) ... especially those held on computer?

OK from the top
1) Remove 'offending' Equipment and/or accessories/consumables
2) Request the incident report
3) next please.

Even the Police can get it wrong. About 6 months ago one of our guys took a call from a local Police Woman saying that a community based patient had died whilst they were attached to one of our ventilators. The immediate implication was that this ventilator had somehow contributed to their death.

We didn't hear from the District Nurse but heard straight from the Police. They got it completely wrong of course, but for a while in our dep't (and in the Trust) there were a few twitchy bums. We checked all our records (paper based and electronic) and we were ok. Not only did they get the equipment that the patient was connected to wrong, but there were a whole host of other contributing factors at work as well. The tech involved got no apology though.