IVD and Point of care testing Mark Grumbridge – Nursing Advisor, Devices MHRA

What is an in vitro diagnostic medical device (IVD)? Broadly, a device is an IVD when the manufacturer has intended its use for the in vitro diagnostic examination of specimens derived from the human body. IVDs can include:

What is an in vitro diagnostic medical device (IVD)? blood glucose meters, pregnancy tests, test kits used in hospital laboratories reagents, calibrators and control materials, whether supplied alone or as part of a kit analyser systems, analytical instruments, apparatus or equipment

What is POC testing? Testing, using an IVD device, that is performed near or at the site of a patient with the result leading to a possible change in the care of a patient. Examples of these include: Blood glucose testing Pregnancy testing Blood gas testing Urinalysis testing Does not cover home/self testing or laboratory based testing.

Typical POCT devices

Blood Glucose meters

Glucometers – The Science The science behind these modern blood glucose meters is to draw in a set amount of blood. Often it is 1 microliter (a millionth of a liter). The glucose in the blood reacts with an enzyme called glucose oxidase that pulls 2 hydrogen atoms off of the glucose molecule. A third chemical pulls the 2 hydrogen atoms off of the glucose oxidase enzyme. The third chemical then has those 2 hydrogen atoms removed by the use of an electrical current. By measuring how much electrical current it requires to remove these hydrogen atoms, the number of glucose molecules can be calculated

Plasma / Whole blood testing Capillary blood used for test strips Lab testing uses plasma Some test strips are calibrated to give results comparable with lab testing (av 12% higher than whole blood)

Choice of equipment - considerations Suitable to be used in the intended setting ? Is it single use or can it be used on multiple patients ? Is the device CE marked ?

Units of measurement UK units of measurement are mmol/l Other countries use mg/dl Ensure the device is set to mmol/l

Training should include……. Basic principles of measurement Health & safety Calibration and QC checks Trouble shooting Patient management Competency

SOP Standard operating procedure MUST be in place wherever BG testing is undertaken Includes the manufacturers instruction Use in conjunction with local policy / procedure / guideline

Quality control Calibration for each new pack of test strips Internal and external quality assessment

Consumables Consumables such as test strips, lancets etc must be compatible with the device

Management of results Ensure accurate recording, maybe paper recording or electronic Ensure staff act appropriately with any abnormal result

Incident reporting Report locally by following internal policy (DATIX) Direct to MHRA Direct to the manufacturer Quarantine affected devices and equipment if necessary Ensure alternatives are available if the product(s) are recalled

Further sources of information Management and use of IVD point of care test devices - December 2013 Blood glucose meters booklet POCT Top ten tips Management of IVD medical devices All available at www.mhra.gov.uk/safetyinformation