Now that the "bonfire of the quangos" has disappointingly (to me, at least) fizzled out as yet another "damp squib", let me (not being particularly scholarly in this regard myself) toss this one in the direction of the literati:-

Just imagine that a new biomed venture is setting out its stall, or an existing company is revising its SOP’s*, or indeed an NHS biomed department is taking another look at its Policies and Procedures ... can anyone point to a concise list of "agencies" or other bodies that must be obeyed, who has over-sight of what aspects of biomed, whom takes precedence over whom, the official status of each "agency" (acronym?) – government (force of law?), voluntary, code of practice, "guidelines" or what-gave-you, how they relate to (or overlap with) each other ... and anything else pertaining, in order that all may be given due consideration (or indeed deference) as deemed necessary (and/or prudent).

I’m talking about the UK healthcare scene here, of course, but not only the NHS.

I have in mind the likes of:-

BMA
MHRA
RCA
RCN ... et al.

As well as the more "generic" stuff like:-

COSHH
HSE
RoHS
WEEE ... etc.

On the other hand (and meanwhile) here's a .pdf with an international perspective.

* Standard Operating Procedures.

And (continuing in similar vein) we all believe in the necessity of conducting a good PM regime, do we not?

But ... under whose authority is PM carried out (the Trusts Boards?) ... and who says what is to be done, and what the frequency should be? OK, "the manufacturers' service manuals" you might say. But who is to say they are any good? Who is the judge? What "weight" do manufacturers' service manuals actually *have?

The Electricity at Work Act (and similar legislation) can be pointed to as having the rule of law to enforce it ... "Duty of Care" and all that good stuff. But what about PM? Like many I should imagine, I could name hospitals that seemingly do not bother too much about PM at all, whilst others worry when they are "only" 95% in compliance by date. And it's a similar story (is it not) with electrical safety testing.

When a contractor is appointed to carry out the work, the contract can contain clauses like:- "work shall be carried out in accordance with relevant manufacturers' service documentation ... " etc., etc. But otherwise, what is the official basis for carrying out PM? Actually.

* Especially when bearing in mind the "quality" of some of them!

Geoff, this seems similar to the situation that I am in now with JCI accreditation, one has to have a Medical Equipment Management Plan. This includes all the aspects of the equipment from birth to death, recalls, risk, PM, Service orders, purchasing procedures. This is a separate item from the policy and procedures but must still encompass them. It has been a good exercise, now I am waiting if it will be adapted as it will mean quite a few changes in the purchasing structure and hopefully for the better. We may get the planning and tendering committee that has sadly been missing for a long time.

Take a look at the WHO document I linked to earlier, Neil. It looks like a reasonable basis for a "Medical Equipment Plan" to me. In fact, why not simply refer to that as your Plan?

Personally, I can't see the need for this apparent plethora of overlapping regulations and guidelines (hence my original post). There's a World Health Organisation, so why don't we all just follow what they say? If we find that their stuff is a load of [censored], then we "pass it up through channels" (in our case here, the Department of Health) to get it put right, "harmonised" (whatever).

Remember, even in the biomed world, the Wheel was invented some years ago now!

Or, put another way, kit is kit ... whether it is being used in Jeddah, Johannesburg or Jarrow!

Meanwhile, in the UK I believe that the key (base, master, whatever) document is DB 2006(05) "Managing Medical Devices" issued by the MHRA on behalf of the Department of Health.

It mentions the Electricity at Work (EAW) Regulations as the "legal requirement for electrical safety testing".

It also states (amongst other things) that:- "The frequency of servicing should be based on the manufacturer's recommendations otherwise the provider will carry increase liability in any subsequent litigation".

The first point that I make in the plan is that the Biomed Manager/Clinical Engineering Director or whatever fancy title people like to call themselves is the one that has overall responsibility for all the biomedical equipment within his jurisdiction, be it loaned, bought, patient owned it does not matter. If it is being operated within his/her jurisdiction then responsibility for operational, maintenance procedures will be his/her responsibility regardless of outside influences.

Hi Geoff,

I've had some fun looking into this myself and the straight answer is that there is no single body that strictly governs medical devices.

There is the MHRA and, as you state, DB 2006(05). This document is great as a guide but when you look for specifics it states "manufacturers instructions" .

For the NHS, there are 2 other regulators that come to mind:

- Monitor (applicable to NHS Foundation Trusts only). They regulate all NHS FT's to ensure they are operating correctly. Whilst their main focus is on the financial aspect of the trust, they do also ensure that other applicable guidelines/regulations are being adhered to.

This is where the other regulator steps in:

- The Care Quality Commission (CQC). These guys regulate all healthcare providers in England (but don't cover Wales and Scotland to my knowledge ). The CQC released new laws following the merge of the Healthcare Commission and the Care Standards Committee. They revised the Health and Social Care Act 2008 and the most recent addition is the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010. The new regulations have been designed to focus more on patient care and the CQC created a number of Essential Standards of Quality and Safety. Many of these are designed around the people receiving care and, specifically, Outcome 11 (or Regulation 16 of the Regulated Activities Regulations 2010) relate to ensuring that patients are safe where equipment is used for treatment/diagnosis because the device is maintained properly and records are kept.

This being said, it still does not put specifics on how often this should be done and that is where wording from the Health and Safety at Work Act 1974 (HASAWA) can play it's part - "as far as is reasonably practicable".

What is "reasonbly practicable"? Who determines what it is?

From my experience in Electrical Safety Testing (Portable Appliance Testing) it comes down to running risk assessments are deciding yourself what you feel is suitable given the level of risk to patients/users.

The key thing is, if worse comes to worse and it goes to court concerning maintenance of the device, have you (the duty holder) taken all reasonble steps to protect patients and users from risk of malfunction. If you believe (and truly believe and have a paper trail to back it up (risk assessments, certificates of inspection and testing)) then it makes things a little bit easier.

Hi Geoff,

Further to your post about other associations, I haven't spent much time with GP regulators other than the Royal College of GP's who said that they do deal with maintenance enquiries and operate a practice standards scheme that includes standards for best practice.

Also the Care Quality Commission (as mentioned above) will be regualting all GP's come April 2013 (it was April 2012 but they secured an extension).

Most GP's are pretty good to be honest and have their equipment maintained / checked by one company or another. All GP's now participate in the Quality and Outcomes Framework Agreement (QOF). One of the mangement sections is strictly for checking medical devices. The latest figures from DoH for April 2009 - March 2010 show that 270 GPs did not meet the required standard to achieve this goal. That equates to 3.25% (not a huge number).

The same however cannot be said for my experience with the Pharmaceutical or Dental Industries.

I have tried speaking to the various bodies and regulators and none of them are very forthcoming with information and generally just pass me onto a different organisation until I end up going full-circle!

I believe that more needs to be done in the industry in general (GP's, Pharmacy, Dental and possibly the NHS) to highlight the importance of PM (especially when comapared to the cost of reactive maintenance when things ultimately breakdown because of a lack of regular servicing).

John's article is useful in this regard.