Medical kit user guides launched

GUIDELINES for using medical test-kits and analysers safely and effectively were launched yesterday by Health Minister Mary Harney.

Technological advances have resulted in the widespread availability of relatively simple devices that allow blood and urine samples to be analysed outside of a laboratory.

Applications range from simple dipsticks for analysis of urine to electronic meters for screening for some common disorders or for monitoring responses to therapy.

The devices are regulated under the EU Directive on in-vitro diagnostic medical devices.

There are concerns, however, that incorrectly performed tests or inappropriately interpreted results could put patients at risk.

The guidelines have been produced by a Point of Care Testing Consultative Group, set up in 2006.

Many risks can arise from poor operator competency; lack of proper supervision; inappropriate testing by inexperienced personnel and uncertainty on how to act on results.

The group wants hospitals to have a policy consistence with the guidelines.

Areas covered include requirements for overall management, operator training, quality assurance and interpretation of results.