EBME Forums Forums Maintenance Technical Assistance External Temporary Pacemaker

We are presently using the APC Medical Model: 4170 Pacemaker. Just received a notification dated the 1st September 2011 from the USA parent company giving a recommendation that these devices should be replaced every ten years.

One of my staff contacted APC Medical UK for spare parts and was asked the age of the device. On stating the age to be eleven years a response of it should not be repaired but replaced was given.

I have contacted the MHRA on this at least to state that we all need to be notified of this 'recommendation' and make the appropriate decision around it. This will vary between one Trust and another no doubt.

Do you guys know of any other external temporary pacemaker devices on the market which may be similar to the Model: 4170? Remembering of course the need for comprehensive service documentation and access to all spare parts (PPQ question 5 - all six parts)

Thanks

Jim

It is not as if it is a mechanical device that "wears out". Is there any reason/justification from APC as to why it needs replacing or which bits fail? If you knew that you could do planned maintenance and replace those parts.
Robert
Or is it just a sales ploy.......?

In answer to your question, it is the first time I have heard of any electronic device "wearing out".

Surely the word is "scam"?

OK ... some electronic components may drift a bit with age (thousands of on-off, warming up, cooling down cycles) ... but that's one of the reasons that kit needs to be calibrated every once in a while, is it not?

@Jim:- are these things that complicated that they can't be repaired or cal-checked if need be "in-house", or by any half-decent biomed services company?

Hi Jim,
As you'd expect (clues in the name of the hospital) we've got loads of external pacing boxes.
Medtronic 5388 dual chamber, being the flavour that suits our taste best.

Hi Chaps

Thank you for the replies on this. The inference from APC Medical Ltd is with regards the passive components, namely the resistors going high and the capacitors drying out, leakage, potentiometer wear and tear, etc.

I obvioulsy agree with you chaps, carry out an annual or six monthly check as per the norm. Replace any faulty, defective or out of specification parts/devices. Probably the usual USA concept of litigation avoidance issues.

In reply to your question Geoff, they are most certainly not complicated, though again the USA contingent are perhaps of the opinion that they are. I have voiced my opinion on this quite robustly with explanations. I have been maintaining this manuafacture of external pacemaker since 1975 (37 years), simple little criters that they are.

As stated previoulsy I have raised this to the MHRA as an adverse incident report, because we at least need to be aware of this matter and deal with it accordingly, as we each see fit.

Karl, I will look at the Medtronic range as we only require single chamber pacing. I will pick your brains on relaibilty, service documentation, spares, etc at our managers meeting in Halton General Hospital on the 17th April, I'm bringing the biscuits I believe.


Reagards to you all.

Jim

Hope you get somewhere with the MHRA Jim. In my experience they default to supporting the manufacturers position most of the time. If so then it seems all critical support equipment should be binned on it 10th birthday!