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Joined: Dec 2007
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PeteD Offline OP
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A concerning question I have witnessed within my workplace. Would you allow someone that has some ventilator experience, but no factory training on a LTV 1200 to troubleshoot it. Especially after a alleged incident with the device ? Is there any requirement by the workplace that you should be only factory trained to work on these or troubleshoot these, my understanding that you should be.

thanks for anyone's input on this.

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Super Hero
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Servicing and troubleshooting - two different levels (skill-sets) of endeavour.

Otherwise, it would depend upon the details of the situation. For instance:-

1) What was the nature of the "incident"?
2) How competent is the tech?
3) Is the Service Manual readily to hand?
4) How much pressure was there to get the vent back into service quickly?
5) What did the tech reply when you asked him about it?

I may be "old school" (OK, there's no "may be" about it), but the great majority (almost all) of the kit I worked on in my time was stuff I had never been formally trained on. And that often included "critical" items like anaesthesia gear, vents, imaging stuff ... and all the rest. Any items that I could not sort out never got returned to the user. I was never exceptional ... it's just how we were back then (the mind-set we had, our backgrounds, the initial training we went through, and the mentoring we received).

Of course, in a Perfect World, "everyone would be trained on everything" (and therefore, being always away on courses, would never be available for actual work)!


If you don't inspect ... don't expect.
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Savant
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If its an incident investigation then as part of the investigation you should simulate a patient and run it. This can be done with the manual or another trained member of clinical staff. To open it up and further investigate i would have someone who is factory trained. Two levels of user really.


30 years since the Chernobyl disaster and yet we still have no super heroes or zombies.
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Super Hero
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As is well known, it is the expected norm (in the "Developed World", at least) for hospitals to have clear policies about how to deal with equipment following its involvement in a "patient incident".


If you don't inspect ... don't expect.
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Master
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Generally medical device regulations, including those in the UK and Canada, require all incidents involving medical devices to be reported to the manufacturer (or their agent). Therefore, I would start by notifying the manufacturer and see if they want to be involved with the investigation.

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PeteD Offline OP
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I appreciate everyone's input. I have been in Biomed myself for 30 years, like Geoff I have worked on many devices without having factory training. I used to do gas machines but did a two week course with GE in the USA, which certified me to work on and troubleshoot this device. A vent is a level 4 device in Canada, in the same class as a defib. I would think in my opinion, like the gas machine, that to do any work on a ventilator (which is much different than doing troubleshooting on a iv pump etc) would require technical training by the vendor, especially when there may be an alleged incident involved. Liability for the hospital for example, if the device failed on a patient, then they would look at the device, who serviced it and did the person servicing that device have the proper training. I'm not the manager , just a tech in the department and I just think in the case of a ventilator that a person working on it should be trained. After talking to my retired colleague who worked on these LTV 1200 units, tells me they difficult device to work on and deserve a level of competency and should require a factory trained person.

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Super Hero
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Yes; interesting points ... and I can imagine that certain questions could cause embarrassment should any case go to "court".

Sounds like the Manager could be the one with some explaining to do.

As usual, my advice is to keep well out of (away from) it all if you can.

Meanwhile, I have always thought that biomeds should be "certified" to work on certain types of equipment - anaesthesia, ventilators, x-ray, lab analyzers, dialysis and so forth - via recognized training, possibly followed by periodic (annual, every five years, or whatever) re-licencing. Rather like the CORGI scheme for gas fitters. But unfortunately, the UK authorities have never felt the need to take such a step.

I'm not talking about simple Registration there, but actual practical evidence of appropriate skill sets.

So we just have to muddle along, relying on the techs always doing the right thing, and (not) supporting them when things go wrong.

We have "Guidelines" (only) issued by the Government ... but are subject to "Laws" when things go wrong. And never judged by peers, I might add - after all, what do juries, lawyers et al know about "biomed"?

"Integrity - a man's gift to himself".


If you don't inspect ... don't expect.

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