EBME Forums Forums Management Medical Equipment Management Manufacturers recommended vs ? based maintenance

64 now and at a cross roads so to speak, recovering from an illness that has devastated me - i don't know what to do, still thinking about my ebme role though LOL

in my beloved RAF, broadly speaking, we went along with APs etc, me going from the good old boys TG 5, Aerospace Ground Equipment, Radar, Missiles then Medical equipment and a host of other things in between. We always went by the book - every ebme policy I've written since had these words (Medical Equipment will be maintained in accordance with manufacturers recommendations).

I've spent a fair amount of my career in the commercial 3rd Party world and some outfits have been very good, good - some dire) before becoming almost Tea Total - I cant remember a lot about, quite a lot - but as an old sweat - Manufacturers recommendations in my mind should not be deviated from. Ive been having nightmares - I do need to chill I think - but you might know how I feel. I've seen more false economies than Donald Trump and concluded years ago, trying to save money is noble and wise - providing better services with less resources is a challenge - that may possibly cost lives.

I've seen fashions come and go risk centred this reliability based that, cancel this support contact, do not maintain, demand maintenance only, remove maintenance profile don't calibrate that - I don't care for it, if my team are not trained by the manufacturer, in my mind - they undertake the very basics, I'm old enough to know my way around most imaging modalities for instance but wouldn't dream making adjustments to high risk complex modalities, its so bloody woolly and very subjective and I worry - There you go - off my mind.

For my sins I'm an AP(D) and the Trust (Decontamination Lead) - Appointed roles - Bringing in new technology & proven science, I love it - I have access to an AE(D) infection prevention/control teams & OEMs for advice and all is always well - Its all back and white comforting and I think, I have heard that there may be AE (Medical Devices) - a great move I think - please comment on the above the new or proposed role of the AE(MD) if that's right.

Big D, Howling Mad Magee, Savant Neurodivergent and a host of other names - even The bold Magee & Eye Candy - Once upon a time - its been a good life and I'm never going to retire but will i stay in the NHS, I'm not so sure?

Sorry to hear about your illness, Mate ... I hope you're back firing on all four again now.

Maybe what the The Bold Magee missed out on was doing a bit in the "Magic Kingdom" (or perhaps a "locum" or two at the King Hussein Medical Center in Amman) ... am I right in that assumption (that you did not venture forth)?

Out there, and back in the day (as it were) we were often able to practise a bit of "innovative repair techniques" without having to worry too much about what the manufacturers might want to say. We were generally more clued up than the manufacturer's local agents, anyway. A completely different situation (and to my mind, far more satisfying) to the current (last thirty years or so) scene in the UK.

Best to get out of the NHS ... write your book (life story) and (or) do a bit of consulting.

By the way, you missed out "Evidence-Based Maintenance" ... in short, adjusting the schedule (interval) and (or) carrying out some other action(s) based upon the condition of equipment as PM is completed. You could call that "Condition-Based" I suppose ... but I believe that was to do with equipment condition as found during regular inspections ("walk through inspections", for example) ... that is before any attempt at PM.

Spot on Geoff I was the Chief Medical Physics & Biomedical Engineer at the Royal Commission in Yanbu - and yes a different maintenance philosophy reigned - even back then - been through the spectrum and reflecting. that's all

You do when you've nearly died! Again......LOL and seeing what the regulatory and compliance bods, HSE. MHRA, QCQ think - "Best Practice" seems to be the order of the day.

And the book is in progress - its called Squeaky Dirty and all about people like us, your chaps in REME and our RAF TG5 gods - no forgetting the senior service, scruffy buggers - fond SEE memories Geoff

The first chapter is about me, I'm letting our brothers in arms compile the rest in all its glory, with the odd edit to protect the softies, meek and mild from the Darkest of Military humour - its on one of my Linked in Groups - Ill pop the first pages on the ebme Linked in group so you can have a peek. I was the worst Geoff but I make no apologies for it, instead I celebrate all my faults, evil ways and dastardly deeds - I reckon my mate Greybeard could write a few volumes, people dont realise what weve seen and done my friend

I hadn't known you had been at Yanbu, Darren. Were you with the RC team, or with the hospital contractor?

I did not hang around at the hospital (MYAS RCMC) for very long myself; there was too much "politics" and back-biting going on for my liking. At that time the place was dominated by Brits and Irish ... I may as well had stayed in London. Luckily I was able to escape to another hospital greater to my taste ... in fact I was the only Westerner in town!

Apart from wishing I was still out there, my main regret about my time in KSA is that I wasn't out there ten years earlier (I was first in Jeddah in 1982). It was reasonably "pioneering" but would have been even more so a decade before.

With the exception of MODA, during my time I was involved with most of the usual suspects:- Royal Commission (both Yanbu and Jubail), MOH (many and various), SANG (ditto), and the AOC (Arabian Oil Company - not ARAMCO - at Khafji). Plus various private hospitals and clinics here and there.

The only time I ever got reasonable money (and dare I mention, "respect") was when I got involved in New Hospital Projects: generally as a (key) member of the Hospital Team with Consulting Engineers and Architects. I found that I was suited to such work, whether on site or at the office, and it suited me as well (no gang to "manage" and not a patient in sight).

Good for us creative types, too; reviewing drawings and equipment proposals, a bit of design work, writing specs, database work, "clerk of work" type inspections at site, sorting out problems at site (to allow the contractor to crack on) and so forth. I first had a go at stuff like that (as a civilian) back in 1988, and I should really have stuck with that way of earning a crust (falafel?), but for some daft reason was always hankering to "get back on the tools".

I have often considered having a go at a book, but (as mentioned on here once or twice before) have only got as far as the title:- "No Good Deed Goes Unpunished"!

Looking again at the title to your thread:- "Manufacturers recommended" -versus- what-have-you ...

Of course manufacturer recommendations should always be respected and considered, but the trouble with simply following such words of wisdom is that they can vary greatly (in terms of both quality and practicality) from manufacturer to manufacturer, even within equipment of similar (or same) type.

That is why I have always advocated developing PM procedures in-house. In a word:- consistency.

A little of both, I remember being a proud member of the Yanbu Stray Cats , some fantastic bars with Sid stills with more instrumentation than an ARAMCO refinery. Basically I reequipped the hospital top down and went home - Richer, with a tired out liver and a bit nuttier - all a blur but some top guys, even the Saudi colleagues. they even let me recruit the first lady biomed in KSA and she kindly gives me a mention in her thesis

I like you Geoff have practiced a blended approach to Medical Device maintenance philosophy but since working in the Decontamination area , I have my kids say - turned into turned unto Sheldon Cooper and re the NHS have held fast in ethics these days:- its almost burnt into my moral code! - I'm a changed man I suppose as i analyse my working life in ebme, its turned full circle - lately as a Trust compliance lead for Medical Devices and Decontamination. an AP (D) Trust Lead (D)- Board a appointed roles and a critical avid researcher in infection control, materials science and AI Diagnostics. And on the side an environmental innovator A right royal tea total pain in the arse LOL!

Here are some references I read that support the safety advantages of Manufacturer-Recommended Maintenance (MRM) over risk-based, fancy dan subjective models:

The UK Health and Safety Executive (HSE) emphasises that following manufacturer guidelines ensures equipment remains in an efficient state and reduces risks associated with improper maintenance.

The Institution of Engineering and Technology (IET) highlights that safe maintenance procedures should prioritise manufacturer recommendations to prevent unexpected failures and ensure compliance.

Sources Supporting MRM as Best Practice:

MHRA Medical Devices Regulations – Emphasises adherence to manufacturer guidelines for patient safety.

FDA Medical Device Maintenance Guidance – Stresses importance of following approved maintenance protocols.

WHO Medical Equipment Management Guide – Recommends standardised servicing for high-risk devices.

Risk-based strategies can work when applied appropriately, but for critical healthcare equipment, MRM remains the gold standard. We know most people are killed by the "small" devices maintained on demand - All Medical devices are critical - some low risk in use but high risk for maintenance - What I'm saying is a Greybeard or Magee maintenance profile will look different to a younger chaps - they could be country miles apart

These sources reinforce that MRM is generally the safest approach, particularly for high-risk medical devices, as it is based on extensive testing, regulatory compliance, and device-specific risk assessments. Would you like to explore structured governance models that integrate compliance with optimized efficiency?

Yes, decontamination of medical equipment is enshrined in UK law and regulatory guidance particularly to protect patients and healthcare workers from infection risks.

Key Legal and Regulatory Foundations

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
Requires providers to ensure equipment is clean, secure, and suitable for use, with proper decontamination procedures in place.

Control of Substances Hazardous to Health (COSHH) Regulations 2002
Mandates safe handling of biological agents, including decontamination of contaminated equipment to prevent exposure.

Care Quality Commission (CQC) Regulation 15
States that equipment must be safe and properly maintained which includes **effective cleaning and decontamination

MHRA Guidance
The [Medicines and Healthcare products Regulatory Agency](https://www.gov.uk/government/collections/decontamination-and-infection-control) provides detailed guidance on decontamination, including for surgical instruments, endoscopes, and dental equipment

Health Technical Memorandum (HTM) 01-01
NHS England’s [HTM 01-01](https://www.england.nhs.uk/publication/decontamination-of-surgical-instruments-htm-01-01/) outlines the management and decontamination of surgical instruments used in acute care, setting national standards.

Managing Medical Devices – GOV.UK
This official guidance confirms that medical devices must be decontaminated and stored in accordance with legislation and validated procedures.

In short, yes—it’s a legal and regulatory requirement, not just best practice. Especially Decontamination.

And the bold Magee - I refuse to save money to increase risk to patients and although the order of the day for the government is spend less be more efficient, (That's OK) instead of embe being forced to cancel contracts on high risk equipment, use non original parts etc i see hospitals appointing execs paid god knows to undertake made up roles, Directors of people, relationship Directors, all with deputies PAs etc - getting off my high horse now - Mrs Magee says I'm turning into a Grumpy old Man - But i can see and its not just me, its false economy and not right - Its given me another term for my book, papers, articles and my Linked in Groups though - "Magee's inverse Fair Law"

Darren

"Would you like to explore structured governance models that integrate compliance with optimized efficiency?" ... not really; but that is a useful list for "younger viewers".

I am not a great fan of the "Rules-Based International Order", "Globalisation" ... or even the "Settled Science" (surely a contradiction in terms), either; no surprises there, then.

But I like COSSH, by the way. It probably needs updating.

"All Medical devices are critical" ... not so; especially in the (many cases) where replacements are close at hand.

Regarding the "blended approach" (is that similar to the "blended families" I hear abour?) ... well, that was back then (and far away); it was more like "needs must" I would say. We did our best, supported the medical and nursing staff, got the kit going again, and never killed anyone (as far as I am aware).

I should imagine that not only are the Greybeard and Magee maintenance profiles country miles apart, but (probably more importantly in the Real World) separated by great distance financially! And I already know that younger folk are not much interested in the "history" outside of the NHS anyway.

But rest assured that I agree with the bits in your final paragraph about unproductive but instrusive "managers". In my time I have had two goes at working as an Agency Tech at various NHS hospitals. The first period was in the early 90's ... the second ten and more years later. There were definitely more occasions of folk "interrupting my work" during the latter period.

Lastly, my own interest in the variations of this-and-that approaches to equipment PM, is that I endeavour to include as many sensible options as seems reasonable in my software; which is still aimed at those biomeds that, despite now usually having access to the internet, may still be struggling out there in other parts of the world. After all, computers and "governance" are all very well (perhaps), but they still don't fix the kit.

That's interesting what you are saying about re-equipping the hospital at Yanbu. But when was this, I wonder?

When I was there (1993) the kit was still quite new. But it was a strange mixture of familiar (British) and Japanese gear. The construction contractor at MYAS RCMC had been Mitsubishi-Fudo, of course.

Yes it was a bit strange but beautiful at times, great team and camp 2 social life the best.

On or about Millennium time Geoff, took about two years to replace a lot of kit, The Royal Commission came up with a substantial budget- but enjoyed it, most were wonderful, trained the first ever lady biomed in the KSA (or so was told) - its a hard place to satisfy your morale code without sid - so the bold Magee fell off the wagon - again - and ended up howling mad - went home - Joined Medical Physics International - happy days

When I think about it, the best thing I did was giving up excess, I have some good stories but was not a nice guy though - I'm really an advocate for the evolving (or is it cast in stone now) the role of the Medical Device Authorising Engineer. Has John Sandam and that clever young colleague from Medical Physics International (forget the name) written all over it, its its about time, tired of woolly guidelines & toothless regulatory bodies, and my work with AI, or SI (structured intelligence) in connectivity, diagnostic imaging, endoscopy, and pathology equipment, has led me down another path, John instrumental in shaping device management policies across the NHS and private healthcare sectors. I've gone down another path, from the environment tackling AMR to universal consciousness and Quantum phenomena back to AI as digital organisms.
My day job has like Johns championed the shift from device-based to systems-based management, emphasising the growing complexity and connectivity of medical technologies. my pension pot filling with IP, on devices, disease and cancer treatments thought of before consulting to joining the NHS - one design of mine got an investment of £200,000 on Dragons Den - well Shark Tank and hope to float on the NASDAQ - well Trump might have Knackered that !
We had one of the first AI endoscopy diagnostic devices, 3 seconds with a 98% accuracy, ready to go but to be honest more failures than successes i need to talk with others in AI integration in Medical Devices but getting distracted by programmers (not fond of physicists) LOL Johns work aligns closely with devices but my works is steering towards Estates these days (environmental prevention rather than cure) an approach which makes me conclude - it might be my newly freed autistic traits but over the last 7 years or so (my grandkids. they call me Sheldon) I firmly believe increasing risk to save money is false economy and should not be an option - EBME - we will need more OEM trained and qualified/staff which will will work more effectively supported by admin/contract officers etc