Hi Charlie,
I would argue that EBME department managers are and should be closely involved with authoring of the medical devices policy because they should be at the centre of medical equipment management within the organisation.
Therefore, their knowledge of equipment management must encompass a good understand of business needs of the Trust. The medical devices policy should describe the course of action, and how to do those actions for compliant device management. This involves sitting on a medical devices committee with a broad range of professional colleagues from procurement, medical, nursing, maintenance and governance/management areas within the Trust and discussing policy & processes that need to be actioned.
"should ensure processes are in place for acceptance testing"
a policy matter"These processes will check"
a policy matterNormally, the gatekeeper is the procurement team, but they will not have the expertise to understand the medical equipment technical, clinical or regulatory needs for each piece of equipment ordered.
Every EBME department should manage the acceptance process. They do not set the clinical spec for the equipment, but if a cardiologist orders an ECG with interpretive software, this can add £5K onto the cost. If the technician checking the equipment does not know what the clinical spec required is, how can they check it? Procurement should be discussed and approved in accordance with the policy.
A gate keeper is needed - a policy is needed to set the course of action - within that policy there should be a process for buying - within that process there should be an EBME process for acceptance testing.
A well managed hospital will ensure their EBME dept are at the heart of this process with the support of other professional practitioners.
I would argue it is the job of the EBME dept to work very closely with the procurement dept to ensure equipment procurement strategy is planned. It is not about overseeing, it about teamworking, professionals across depts supporting good inventory management, thereby improving practice, reducing risks to patients, and reducing costs.
I did not say the EBME depts should make clinical assessments, but the EBME dept will want to know if they can get tech training, parts? The EBME dept should be able to give advice on whether the equipment is robust, whether the service costs are fair? i.e. The EBME dept should be involved in buying equipment. A good EBME engineer should offer the clinician advice in areas they do not understand, and the engineer is qualified to do.
I had an incident where a consultant used Trust funds to buy a piece of equipment that was approx £100K. My technician failed it on the acceptance test because it was not CE marked. It had been imported from the USA and did not meet MDD/93/24 regs. He had also broken EU procurement law because it was over the OJEU tender threshold. This was picked up by us, the equipment was returned, and the consultant got a slap on the wrists. The moral of the story - even very experienced clinicians are sometimes
"NOT capable of spending tax payers money ...ensuring that the product they decide on is right for the job that they want to do"
We need to work with other professionals to share our knowledge and assist good procurement practice, this will lead to improved teamwork and improved healthcare organisations.
I still believe that many EBME depts are under resourced and stuck in basements. Unless we raise our profile and involve our profession in equipment management (buying, training, maintenance, and governance) we will always be stuck in the basement. I believe that we have a lot more to share for the benefit of our profession, and for the benefit of patients and taxpayers.
