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
