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Keeping Up to Standards MADAM - I am writing in response to the note published at the end of January's leading article, concerning electrotherapy equipment, the Med- ical Devices Directorate and the EC Medical Devices Directive.

In 1994 the Medical Devices Direc- torate became the Medical Devices Agency (MDA) - an executive body with very similar responsibilities and objectives, but funded by contracts rather than directly from central gov- ernment. In Scotland the function of the Medical Devices Agency is largely paralleled by the Common Services Agency, which has also recently become an executive body re-named as Scottish Healthcare Supplies (SHS).

Following the failure of many new ultrasound units in Lothian Region to meet the relevant British Standard,

I began a dialogue with the SHSS and the MDA during November 1995. The SHSS has since begun an invest- igation of this problem.

It will be of interest to physiothera- pists to know that all electrothelapy equipment will be covered by UK legislation when the EC Medical Devices Directive is incorporated into UK law. Indeed all pieces of medical equipment from sticking plasters to scanners will be covered and will have to carry a CE mark.

However, although this change puts more teeth into the legal bite of equipment users, it does not guaran- tee any sudden improvement in the quality of electrotherapy equipment. The majority of manufacturers already claim that their physiotherapy ultrasound machines meet British Standard requirements, and suppli-

ers who currently sell machines on that basis enter into a legally binding contract with the purchaser. I suggest that an effective solution to the problem of wayward machines will be a substantial increase in the quantity and quality of independent testing carried out by hospitals and test houses.

Physiotherapists should be fully aware of the situation, and be willing either to meet the additional costs involved in testing, or to stop using their ultrasound equipment. This decision must be based on the clinical effectiveness of ultrasound therapy - is it worth the additional cost? This judgement is not made any easier by the dearth of good clinical trials and the prevalence of poor quality equipment. StevePye PhD University of Edinburgh Western General Hospital

Physiotherapy, Fehuaty 1996, vol82, no 2