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#75887 17/12/20 7:21 AM
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Umi Offline OP
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Hello Everyone,

I wanted to discuss the risks associated with the repair of US & Toco transducers by a third party vendors.

The OEM CTG manufactures of the transducers clear say NO! to the repair of this transducers by third parties as it would be invalid the performance of the device, especially as the OEM has not authorized such repairs.

Taking into account that the negligence claims on our NHS trust in the maternity area alone exceeds some £3billon

When claims go to courts the equipment would be securitized, the OEM would fight unauthorized repair

How would we be ensure our EBME departments are doing the right thing.


UMi-007

"WORK SMART NOT HARD !"
Umi #75889 18/12/20 10:39 AM
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If a third party repaired a transducer they would be doing this with parts that are not sourced or authorised by the OEM, which therefore constitutes a modification of the medical device.

In the UK the MHRA would therefore require the device to be re-registered and re-certified as a (new/refurbished) medical device. If not the device should not be used for clinical purposes.

When a claim goes to court the OEM would have no involvement! A hospital or EBME department may feel they are protected from liability as they contracted the work with the third party. However, they would probably have equal liability, as they failed in their duty of care, by not confirming the device was fit for clinical use.

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How many trusts / ebme departments have been taken to court one wonders.

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Super Hero
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That's a question asked on here many times before, Billy (and we're still waiting to hear an answer).

Again, I would counsel that such matters are best referred to, and left with, Trust Senior Management (which presumably includes a lawyer or two).


If you don't inspect ... don't expect.
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Master
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Originally Posted by billy11
How many trusts / ebme departments have been taken to court one wonders.
You will never know, as most cases are settled out of court!

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Not a single one in my area region of 11 trusts.

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Master
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In the land of malpractice claims, USA, there seems to be more third party repairers of US probes than actual manufactures if my in-mail is to be believed.

The vast majority all claim some sort of quality assurance, I'm just wondering what the experiences of our American EBME college's are ??

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Super Hero
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That's a good point, Malcolm ... indeed, an obvious one to anyone who thinks beyond the limits of the NHS.

Could it be that in the States healthcare is largely run (properly) on a commercial basis?

In general, Americans (USA) tend to have a "can do" attitude. This trait (mind set) is also found (often out of necessity) in some so-called "developing nations".

That used to be the case in the UK as well, but sadly it has increasingly diminished over recent years. The upcoming generations especially, it would seem, have not been encouraged to think for themselves ... but rather to "follow the rules" ... in other words:- "safe" and easy to do (ie, nothing).

colleagues


If you don't inspect ... don't expect.
Umi #75919 30/12/20 10:43 AM
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The USA has always put profit over people, as clearly demonstrated by their current pandemic response.

Now the UK is out of the EU we may see a similar race to the bottom, with a slackening of regulations and standards.

A "can do" attitude may be appropriate in a crisis, such as a time of war, but can lead to errors and poor outcomes.

Given the lack of experience and skill opportunity in the modern world finding individuals with a high level of appropriate experience and competence is becoming increasingly difficult. Thus the need to have good regulations and standards to follow.

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Super Hero
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"The Power of Positive Thought"?

Historically, British Standards have generally been more advanced than anything written in Europe (with possible exceptions of the occasional tome from VDE-DIN).

In other words, "racing to the bottom" is what we have seen (and, indeed, been doing) these last forty years or so.

Does anyone else remember BS-5724 (1979)? It was a great leap forward (from HTM-8 et al).

On your last point, Mike, it reads like you're saying that "techs aren't what they used to be". In that case, I wonder why that should be?


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