According a recent NHS England infection control audit, we are the only practice in south-west London still using a desktop steriliser. I knew practices like ours were a dying breed but did not realise it had gone so far.
Let’s get the facts straight: there is no reason why GPs cannot use desktop sterilisers. No law against it, no professional or core contractual reasons why we can’t. Not even the Health and Social Care Act is against it – the MHRA supports their use.
I suspect the mythology around this goes back to a conflation of concerns about Creutzfelt-Jacob disease, hullabaloos over hospital-acquired infections, and Chinese whispers. But now it is time to correct the nonsense.
I’ve been told several times that Article 14 of the 1993 EU Directive MDD 93/42/EEC (amended in September 2007) prevents GPs from using them. This is untrue. This directive is actually aimed at ‘manufacturers or their authorised representatives or others placing medical device(s) on the EEA market’ – in other words, companies wanting to sell devices.
The UK made this law as the Medical Device Regulations 2002: Regulations 19 and 44, titled ‘Registration of persons placing general medical devices and/or in vitro diagnostic medical devices on the market’ (again, the clue is in the title). NHS guidance from 2007 reads:
Reprocessing units in healthcare establishments responsible for the decontamination of medical devices fall into two distinct categories when considering compliance with the EEC Medical Devices Directive:
– Devices transferred between legal entities (example – reprocessing by one entity followed by use in another) (a)
– Devices remaining within one legal entity (example – reprocessing and use by the same entity or organisation) (b)
And it continues:
Devices remaining within one legal entity – if a healthcare establishment only provides reprocessed medical devices for use in the care of its own patients within that same entity, the requirements of the MDR do not apply (b)
Such decontamination departments do not need to register with the MHRA nor do they need to use a Notified Body, nevertheless they are subject to the duty of care imposed under product liability legislation.
In December 2013, the MHRA confirmed this here.
So GPs are not bound by the EU Directive. But they must satisfy their common duty of care. The Health and Social Care Act of 2008 defines the duty of care in this respect as follows:
Disinfection
The use of disinfectants is a local decision and should be based on current accepted good practice.
Decontamination of reusable medical devices involves a combination of processes and includes cleaning, disinfection and sterilisation according to the intended use of the device. This aims to render a reusable item safe for further use on service users and for handling by staff.
Effective decontamination of reusable medical devices is an essential part of infection risk control and is of special importance when the device comes into contact with service users or their body fluids.
There should be a system to protect service users and staff that minimises the risk of transmission of infection from medical devices. This requires that the device or instrument etc can be clearly linked in a traceable fashion to the individual process cycle that was used to decontaminate it, such that the success of that cycle in rendering the device safe for reuse can be verified.
Reusable medical devices should be decontaminated in accordance with manufacturers’ instructions and current national or local best practice guidance. This must ensure that the device complies with the ‘Essential Requirements’ provided in the Medical Devices Regulations 2002 where applicable. This requires that the device should be clean and, where appropriate, sterilised at the end of the decontamination process and maintained in a clinically satisfactory condition up to the point of use.
And in part three of the guidance it says:
Reusable medical devices employed in invasive procedures, for example, endoscopes and surgical instruments, have to be either individually identifiable or identified to a set of which they are a consistent member, throughout the use and decontamination cycle in order to ensure subsequent traceability.
It also states:
Systems should also be implemented to enable the identification of service users on whom the medical devices have been used.
So the bottom line for GPs using desktop sterilisers is that they need to be able to track their instruments and record which set was used in the patient record.
We’ve built up several sets of instruments over the years. The individual instruments are marked with autoclave proof tape in various colour combinations to identify the set they belong to. We have a matching log book with photos of each set and their colour coding.
When we do a minor op, we note in the record which set was used. We also have a steriliser maintenance contract and have adopted most of the MHRA’s recommendations.
The chief advantages of using a desktop steriliser over disposable instruments are that it uses better quality instruments, has bespoke sets for each procedure and surgeon, same day sterilisation is possible. It’s also cheaper and better for the environment
With the drive to move care out of hospitals, it’s high time GPs started to think about reinstating the desktop steriliser.
Dr Paul Cundy is chair of the GPC’s IT committee and a GP in south-west London.
