Presentation on theme: "IVD and Point of care testing"— Presentation transcript:
1IVD and Point of care testing Mark Grumbridge – Nursing Advisor, Devices MHRA
2What 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:
3What is an in vitro diagnostic medical device (IVD)? blood glucose meters, pregnancy tests, test kits used in hospital laboratoriesreagents, calibrators and control materials, whether supplied alone or as part of a kitanalyser systems, analytical instruments, apparatus or equipment
4What 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 testingPregnancy testingBlood gas testingUrinalysis testingDoes not cover home/self testing or laboratory based testing.
9Glucometers – 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
10Plasma / Whole blood testing Capillary blood used for test stripsLab testing uses plasmaSome test strips are calibrated to give results comparable with lab testing (av 12% higher than whole blood)
11Choice 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 ?
12Units of measurement UK units of measurement are mmol/l Other countries use mg/dlEnsure the device is set to mmol/l
13Training should include……. Basic principles of measurementHealth & safetyCalibration and QC checksTrouble shootingPatient managementCompetency
14SOP Standard operating procedure MUST be in place wherever BG testing is undertakenIncludes the manufacturers instructionUse in conjunction with local policy / procedure / guideline
15Quality control Calibration for each new pack of test strips Internal and external quality assessment
16ConsumablesConsumables such as test strips, lancets etc must be compatible with the device
17Management of resultsEnsure accurate recording, maybe paper recording or electronicEnsure staff act appropriately with any abnormal result
18Incident reporting Report locally by following internal policy (DATIX) Direct to MHRADirect to the manufacturerQuarantine affected devices and equipment if necessaryEnsure alternatives are available if the product(s) are recalled
19Further sources of information Management and use of IVD point of care test devices - December 2013Blood glucose meters bookletPOCT Top ten tipsManagement of IVD medical devicesAll available at