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Diabetes: Medical Equipment

Answer

Once manufacturers of medical devices have demonstrated their products' conformance with the medical devices directive and consequently earn the right to place the CE conformity mark on their products, either through self-declaration for the lowest class of medical device or from an officially accredited European notified body for the higher class of medical devices, they are entitled to place their product on the European Union market. There is currently no requirement in the regulations for manufacturers to standardise different devices, or components of the devices, to make them interoperable with devices from different manufacturers that perform the same function.The Medicines and Healthcare products Regulatory Agency (MHRA) has been in regular contact with the two companies who produce diabetes test meters with similar size test strips, about the issue of problems with users trying to interchange, their glucose test strips between their testing meters. An MHRA investigation concluded that labelling for both companies' meters and strips is clear regarding intended use. However they took the precautionary measure of reinforcing the information about compatibility issues to users/health care professionals.One of the companies has undertaken a campaign to remind users of the correct strip/meter combinations to use. They have also identified a means by which their system would reject the other company's test strips. However this would involve considerable extra cost for both manufacturers and implementation of such a change would be a commercial decision for both to take. To date the other company have said that they will monitor the situation.In addition to this, the MHRA also provided an addition to the EMIS drug database (which includes prescribing information and product availability for general practitioner practices and health care professionals), whereby a message reminding users to confirm that test strips are compatible with the meter in question, will appear on first prescribing any glucose meter test strips.In September 2006 the MHRA issued the One Liners (a sheet aimed at health care professionals, which highlights problems with the use of medical devices) Issue 44, which has been placed in the Library.On 12 February 2008 the MHRA issued the 'Medical Device Alert' (MDA/2008/006), which has been placed in the Library.In February 2011 the MHRA issued the 'One Liner Issue 83', which has been placed in the Library.

Secondary information

Type

Written question

Reference

100278; 542 c623-4W

Session

2010-12

Subjects

Diabetes Medical equipment

Link

View this Written question on www.publications.parliament.uk