Transcript IVD and Point of care testing Mark Grumbridge – Nursing Advisor, Devices MHRA.
Slide 1
IVD and Point of care testing
Mark Grumbridge – Nursing Advisor,
Devices MHRA
Slide 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:
Slide 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
Slide 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.
Slide 5
Typical POCT devices
Slide 6
Slide 7
Slide 8
Blood Glucose meters
Slide 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
Slide 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)
Slide 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 ?
Slide 12
Units of measurement
• UK units of
measurement are
mmol/l
• Other countries use
mg/dl
• Ensure the device is
set to mmol/l
Slide 13
Training should include…….
• Basic principles of
measurement
• Health & safety
• Calibration and QC
checks
• Trouble shooting
• Patient management
• Competency
Slide 14
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
Slide 15
Quality control
• Calibration for each
new pack of test
strips
• Internal and external
quality assessment
Slide 16
Consumables
• Consumables such
as test strips, lancets
etc must be
compatible with the
device
Slide 17
Management of results
• Ensure accurate
recording, maybe
paper recording or
electronic
• Ensure staff act
appropriately with
any abnormal result
Slide 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
Slide 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
IVD and Point of care testing
Mark Grumbridge – Nursing Advisor,
Devices MHRA
Slide 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:
Slide 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
Slide 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.
Slide 5
Typical POCT devices
Slide 6
Slide 7
Slide 8
Blood Glucose meters
Slide 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
Slide 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)
Slide 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 ?
Slide 12
Units of measurement
• UK units of
measurement are
mmol/l
• Other countries use
mg/dl
• Ensure the device is
set to mmol/l
Slide 13
Training should include…….
• Basic principles of
measurement
• Health & safety
• Calibration and QC
checks
• Trouble shooting
• Patient management
• Competency
Slide 14
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
Slide 15
Quality control
• Calibration for each
new pack of test
strips
• Internal and external
quality assessment
Slide 16
Consumables
• Consumables such
as test strips, lancets
etc must be
compatible with the
device
Slide 17
Management of results
• Ensure accurate
recording, maybe
paper recording or
electronic
• Ensure staff act
appropriately with
any abnormal result
Slide 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
Slide 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