IVD and Point of care testing

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

2. 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:

3. 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

4. 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.

5. Typical POCT devices

8. Blood Glucose meters

9. 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

10. 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)

11. 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 ?

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

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

14. SOPStandard operating procedure • MUST be in place wherever BG testing is undertaken • Includes the manufacturers instruction • Use in conjunction with local policy / procedure / guideline

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

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

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

18. 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

19. 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