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

The Tech invoved must have gone through alot of stress...

In a worst case scenio, suppose the Tech had made a mistake what would the consequences be ?

Genuine error or laziness depends how the injured party would look at it.

I am sure i've seen figures from the MHRA and the Aussie equivalent in the past suggesting that a reasonable percentage of incidents are down to mistakes caused during repair/maintenance.

Lee

But are they down to poor training, bad management, finance cutting budgets, it is the injured party who will seek to gain the most. Take railtrack for instance with their poor maintenance and the results of it.

I would be most interested if you could point me in the direction of the Oz figures. I have been around this industry for 20+ years and have seen few that could be put down to mistakes during repair/maintenance. I'm not saying you are wrong it's just that I have not seen it myself.

Another thing that needs to be kept in mind here (and this harks back to the example given about the vent on the home care patient) is, once that equipment has left your control and given that it was tested/serviced/etc correctly (and documented as such) what real guarentee is there that it is still "up to spec" 5 weeks (or days or hours or minutes) later. We can only ever state that, at time point X, this unit passed all the required tests.

Indeed. And once users take it upon themselves to operate equipment, the responsibility for its safe and effective use passes to them. Obvious really, but probably worth re-stating here.

This is especially the case out "in the community", of course. Who knows what they get up to (and judging by the state of some of the kit I have seen, I don't think we really want to know)!

Remember that 'elf 'n' safety laws also place obligations on equipment users (as well as employees). It's not (meant to be) all one way.

Also, it is not the biomed's job to defend the equipment per se. As I have said a fair few times over the years, "I didn't design the damned thing, and neither did I recommend its purchase"!

Assuming there was no criminal intent or premeditated desire to cause harm (!) ... a charge of manslaughter would be the "worst case scenario", I should imagine.

You can research cases on the web, if you are really worried ... but I would expect a custodial sentence if convicted.

My advice is to act with due diligence at all times, and always stay within the Law (in both your private and professional affairs). Even if this invokes the ire of the "bosses" when you fail to meet their productivity demands! Remember that (in theory at least) the Law is there is there to protect everybody ... including you.

In *England, the charge of Corporate Manslaughter is now available. In such cases no single person is held to account, but the "firm" would face an unlimited fine if convicted. It seems that companies (Trusts, what-have-you) can't go to gaol (or, if you prefer, jail).

* In Saudi Arabia (and elsewhere), different rules may apply.

The Procurator Fical is the Coroner in Scotland and it was him that sent in the CID to collect the device. We had already taken a note of the settings and sealed it in bag.

Providing you have been trained to service the device and service it to the manufactures spec and record the servicing with any necessary results, there should be no problem.

Problems may arise where you don't follow the service spec or use copy parts.

Everybody has the right to report incidents directly to MHRA etc, this is especially important when you find faults in a batch of breathing circuits. The MHRA needs to progress this sort of thing quickly as this could affect lots of hospitals.

I can fully sympathise with the guy with ventilator. I was called in here a few years ago to be greeted with "Your defib killed my patient". After talking to the doctor who attended the patient, the defib discharged as expected. It was only the fact that they couldn't get a readable ECG (just lots of lines) and the same happened with a monitor. A demand to be shown the ECG electrodes that had been used, involved the nurse rummaging in the bin. You've gussed it! Bone dry and crystalised. And I had an apology!

Yet again I note the inference that you were expected to defend the equipment. Was it really referred to as "your" defib? (and yes, I can well imagine that it was ... having experienced a fair amount of similar BS myself over the years).

Had you rented out a defibrillator to the doctor, then?

What did the Coroner* make of that incident, by the way? "Natural causes", I hope!

PS: did the patient get an apology as well?

* Actually, I doubt that a Coroner was involved, seeing that a doctor had been in attendance.

Ah Geoff. You have been around as long as me and just as cynical!

Such attacks are often its "your equipment" that killed or injured the patient, never "It was my incompetence and I didn't know what I was doing."

The patient was 86 years old, died of an aortic aneurism and no she didn't get an apology.