Please give me your thoughts.
I wish to know what is the definition of an "Electro-Biomedical Device".
We need to write a policy document, and refering to the MDA they only define "medical devices", this covers anything from rubber gloves to anything else you care to name.

I thought maybe along the lines:
Equipment that is used in diagnosis, treatment, or monitoring of patients that requires either to be connected to a mains supply or derives its power from batteries.

Any other suggestions would be most welcome, :p (about the definition I mean).

Ray,
If you are talking specifically about electro-biomedical equipment - then your suggestion looks spot on to me.

Ray, Your question is interesting to me not because I want to do the same or a similar thing, but it high-lights a small point that has always 'niggled' me. That of the reference made firstly to us as Biomedical technicians and secondly to your query for an appropriate definition for equipment under our jurisdiction. The first point I will not elaborate over, suffice it to say that I have never agreed with our title of Bio-medical engineers as we are not in the field of Biomedical work i.e. working with R & D of the life-sciences etc. The main thrust in our work area is that of the management and maintenance (repairing) of electrical medical equipment and that is all. 'Nuff said!

With reference to an appropriate definition for the large remit and gammit of equipment we look after, well what has always to me felt right ever since I can remember starting in the field is purely and simply Electro-Medical Equipment(or Devices). I have seen written Electrical Medical and Medical Electrical but not electro-biomedical. These just do not 'ring' well with me, feeling rather cumbersome in comparison. I appreciate that the above does not cover your request for a definition. As John says,it seems to cover well the main areas.

Ray, Not knowing if your title for definition is of your own making or from another source, I will assume it is from another source/document and that your are doing this for a wider reading rather than an in-house document. The reason being that I assume that the title has been created out of the need to differentiate when writing your doc. between the equipment under the jurisdiction of the 'Power Boys' (Heavy (Hospital) engineers) and that of us, the (electronics) Bio-Boyos! (light engineering).

In the past we were involved mainly with the 'lighter engineering' side of the equipment, such things as we still do as the 'bread and butter' work, fairly portable 'plug into the wall', mains/battery monitors, defibs pumps etc.etc. The dilemma as I see it in your request is that if you are not doing it solely as an in-house document, then one has to accommodate a big variation in the remit of one hospital to another 'world-wide.' I say this because many hospitals that we (the bio-eng)are working in, such as here in the Near and Middle-East for example, may well have been set up on a different basis than the average Med-Phys/Hospital Engineering department in England. The simple reason being that the demands put upon the individual hospitals during their evolution, and perhaps not having had a specific remit when opened, have created their own variations on what is and what is not considered acceptable for them to maintain and repair under the Bio-eng.

Our hospital for example, which has always closely allied itself to European standards, takes on the following equipment: Pathology Lab (clinical analysis), Dental, Linear Accelerators (Therapy treatment), Gamma Cameras to name but a few of the larger systems that the Bio-engineer is expected to service regularly. X-Ray / CT / MRI departments, 'Historically' not always under Bio-eng, may well feature in the remit of the future as it was only because the Med-Phys of the early days did not take this area on that it still is 'shied-away from' in some hospitals. But there is absolutely no reason for the Bio-engineers not to take the equipment on for servicing. The reason for accentuating this point is that the above equipments are not 'portable' but hard-wired. They would still come under the Bio-engineer and not the hospital engineer as they still have a definite 'clinical' connection.

Try this for a definition:
Electro(-bio, if you must) - medical equipment

Electrical equipment that is used in the - assessment by Analysis, Diagnosis, Treatment and Therapy, and the Monitoring, of a patient's clinical condition.

I personally do not think that the mention of how or where the power is derived is of significance. The point that 'Physics' in particular would accentuate would be the 'Clinical' connection. (I hear voices from our Web-site saying "what has Physics got to do with our work! - Yes what have they got to do with our work!!)

Nick

Ray, As Nick says, it very much depends upon your perspective/reasons for needing to narrow the MDD definition. If, as I suspect, you are seeking to define from a Medical devices policy point of view (Controls Assurance et al), then a point worth considering; there are many 'devices' which are not powered electrically, but are nonetheless involved in the clinical treatment/diagnosis of patient condition. Devices such as pneumatic ventilators, surgical tools (shavers, drills etc),aneroid BP are useful examples of where a Trust would have responsibility for identifying/quantifying risk, training and maintenance requirements, and which may or may not involve our good selves.


I like Nick's definition, and would suggest a slight modification to cater for the above argument;


Any device that is used in the Analysis, Diagnosis, Treatment and Therapy, and the Monitoring, of a patient's clinical condition, and which has a maintenance and/or calibration requirement to give assurance of continued performance.

I think John, Nick and Paul's suggestions are fine and cover a broadbase definition of electro-medical equipment.

May I offer a more cynical suggestion
Any device that has the ability to be dropped by a nurse, tinkered with by an O.D.P., blown up by a Therapist or pilfered by a Consultant and requires a continued service or calibration kit provided, at extortionate cost, by the supplier and can be maintained at great expense by the EBME Dept until the manufacturer either goes bust or refuses to supply any spare parts