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Alf, billy11, Dustcap, Geoff Hannis, Huw, John Sandham, Teknologist
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Original Post (Thread Starter)
#75887 12/17/2020 7:21 AM
by Umi
Umi
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.
Liked Replies
#75889 Dec 18th a 10:39 AM
by MikeX
MikeX
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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#75967 Jan 11th a 05:44 PM
by billy11
billy11
No way third party suppliers do a great service to the NHS bringing the big boys in to line on pricing. I have used many third party spo2 and bp cuffs with no reduced performance. People that claim we should stick to the manufacturers parts clearly have no confidence in their ability to test and determine suitability. We can all just stick to the recommended parts and hide behind 'only following the rules' How many MRHA reports are there of third party probes/bp cuff causing patient harm? Further more if these parts were so bad would the MRHA not have prevented there use?
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#75978 Jan 12th a 05:59 PM
by billy11
billy11
As I stated I will judge by experience and results, no trips to court, no adverse incidents within my trust reported to MRHA due to non OEM parts failures, no adverse results to patients proven. Tested many 3rd party probes on the Lightman and some perform better than the OEM. I for one will continue to use these parts.
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#75982 Jan 13th a 11:29 AM
by John Sandham
John Sandham
Huge savings can be made on lamps Geoff.
Especially for Cold Light Sources.
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#76001 Jan 18th a 12:40 PM
by Alf
Alf
With respect to consumables to effect repair, many of the OEMs actually use the same third party specialist suppliers we do.

When considering undertaking NHS in house repairs (EBME techs therefore being the third party as opposed to the OEM), I think there is a skill in knowing just where to draw the line and many factors need to be considered - the experience and skill set of in house staff, competencies and training regimes and the equipment resilience you have built into your asset register - capability, consequence & risk.

In my experience if you invest in your staff, empower them, you will be surprised what they can achieve - I have been very fortunate to have worked with many NHS EBME staff who could repair anything given the tools to do so, many better than some OEM staff.

Where I have my concerns are repairs carried out by third parties under Managed Equipment Service (MES) regimes, technically that means everything is a third party repair, even those they hand off to the OEM

Not so much with general equipment because a good third party company can provide excellent support but with the high end modalities such as Radiology - I really have my doubts
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#75965 Jan 11th a 05:20 PM
by Geoff Hannis
Geoff Hannis
Steady on, John ... you'll be accused of heresy!

Meanwhile, does the CE mark have any value (if indeed it ever did) now that we are no longer in the EU?
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#75968 Jan 11th a 05:58 PM
by Geoff Hannis
Geoff Hannis
May as well go the extra mile ... are we saying that the (many) suppliers of non-OEM items (batteries, cuffs, probes at al) are trading illegally? ... or at least supporting (perceived) illegal acts (that is, the fitting of non-OEM items)?

What about the NHS Trusts (and anyone else) purchasing these illicit goods ... are they to be dragged into the Dock, too?

What was that sticker I used to see on test equipment:- "For Indication Only"?

PS: as I have mentioned many times before - if in doubt, get it on the Trust's Risk Register.
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#75976 Jan 12th a 04:07 PM
by John Sandham
John Sandham
Hi Mike,
"Its about choosing the correct properly rated equivalent part" but do you really have the information and knowledge/skill to make this decision?"

I would only approve the use of a spare part or accessory where I do have the knowledge to make the decision (and have done so many many times throughout my career). If I was unsure, I would use the OEM part or accessory.
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#75970 Jan 12th a 11:10 AM
by Dustcap
Dustcap
Its a difficult subject and a lot of loose ends as to what is modifying and what is not. What this pandemic has shown (alongside Brexit and the port hold ups) is that without these smaller suppliers to offer parts we would be screwed. The problem with the big companies is that they often run a one size fits all business whereby one giant factory/warehouse makes or holds all of the stock and then whether or not you are a "contracted customer" is whether or not you receive your goods/repair in a timely fashion. I have used non OEM suppliers throughout this pandemic and they have done incredible things. One in particular has better quality testing evidence than the OEM has. They have also gone that bit further and delivered it much quicker than their competitor. We are now hearing that certain items/consumables are held up in ports due to the back log and cant get an estimated date for these items. However the smaller business has sufficient supply. Without these non OEM businesses i think things in the UK would be worse, if that is possible.
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