The Pharmaceutical Journal
Vol 273 No 7320 p533
9 October 2004

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Pharmacists can help MHRA to regulate devices

The 2004 British Pharmaceutical Conference and Exhibition “Medicines: from cell to society” took place at Manchester International Convention Centre from 27–29 September

BPC 2004 summary

The medical devices bill is set to overtake the drugs bill in the not too distant future, Susanne Ludgate, medical director of the Medicines and Healthcare products Regulatory Agency, told participants at the conference. There are currently 80,000 devices on the market. This represents about £10bn annually to the health service and £150m is spent annually on maintenance.

Point-of-care tests are increasing in number, said Dr Ludgate. They offer flexibility in terms of managing patients and allow patients to take control of their conditions. The MHRA has four separate roles (see PJ, 6 December 2003, p780):

· Evaluation
· Regulation
· Adverse incident investigation
· Provision of advice to the health service

Point-of-care tests that the MHRA has evaluated recently include blood glucose monitors, Helicobacter pylori tests, coagulation monitors and cholesterol tests, and the reports are available on the MHRA website. Dr Ludgate explained that since 2000 every point-of-care test that comes onto the market carries a CE mark that demonstrates compliance with the relevant essential requirements, which cover all aspects of safety and performance.

The MHRA also runs the largest user reporting system in the world. The vast majority of reports come from health care professionals. Last year 8,795 reports were received and 46 device alerts were issued to the health service. Dr Ludgate said that the MHRA will be issuing more advice to pharmacists and asking for their help. Point-of-care tests are going to become an increasingly important area for pharmacists, said Dr Ludgate. “You are going to need to know about the tests, and how to report adverse events.”

She encouraged pharmacists to tell the MHRA if they need further guidance on any aspect of medical devices.