Clinical accuracy and repeatability of IR(infrared) thermometer, no maximum error criteria is recommended in ISO

#1
When plan the clinical validation study of IR forehead thermometer, all procedures are based on ISO 80601-2-56 or ASTM-E1965-98.

These standards recommend explicit methods for the determination of laboratory accuracy, clinical accuracy and clinical repeatability.
However, only laboratory accuracy is assigned an maximum error criteria ( ±0,3 °C ) within the RATED OUTPUT RANGE.
For clinical accuracy and repeatability, no maximum error criteria is recommended.
So I don't know if the clinical result of IR forehead thermometer is acceptable or not.


Is there any explanations?
 
#3
Many customer requirements do not come from standards.
TThank you. And sorry, I didn't get that. Could you please illustrate?
I thought a medical device must be legally agreed by acceptance criteria for clinical accuracy or repeatability to be validated,
especially for device with diagnostic functions (ex: febrile or non-febrile).
Otherwise, we don't know how much accurate in clinical use it needs to be safe.
 

somashekar

Staff member
Super Moderator
#4
When plan the clinical validation study of IR forehead thermometer, all procedures are based on ISO 80601-2-56 or ASTM-E1965-98.

These standards recommend explicit methods for the determination of laboratory accuracy, clinical accuracy and clinical repeatability.
However, only laboratory accuracy is assigned an maximum error criteria ( ±0,3 °C ) within the RATED OUTPUT RANGE.
For clinical accuracy and repeatability, no maximum error criteria is recommended.
So I don't know if the clinical result of IR forehead thermometer is acceptable or not.


Is there any explanations?
The average normal body temperature is generally accepted as 98.6°F (37°C). Some studies have shown that the "normal" body temperature can have a wide range, from 97°F (36.1°C) to 99°F (37.2°C). A temperature over 100.4°F (38°C) most often means you have a fever caused by an infection or illness.
This could be one of the reason. Let me know if this helped.....
 
#5
The average normal body temperature is generally accepted as 98.6°F (37°C). Some studies have shown that the "normal" body temperature can have a wide range, from 97°F (36.1°C) to 99°F (37.2°C). A temperature over 100.4°F (38°C) most often means you have a fever caused by an infection or illness.
This could be one of the reason. Let me know if this helped.....
Sorry to reply this late. It helps me be aware of the variability of temperature difference between MEASURING SITE and REFERENCE BODY SITE. For all the human subjects, this difference might not be the same, right?
For example, axillary temp is recorded 0.7C lower than core temp; however; no uncertainty of this value is ever provided. Might this also be the reason?
 

indubioush

Quite Involved in Discussions
#6
I didn't get that. Could you please illustrate?
You are a medical device manufacturer, correct?
Do you have a design history file?
In your design history file, do you have customer requirements and design requirements documented? You are required to have this if you are following ISO 13485. See sections 7.2.1 Determination of requirements related to product and 7.3.3 Design and development inputs.
 

somashekar

Staff member
Super Moderator
#7
Sorry to reply this late. It helps me be aware of the variability of temperature difference between MEASURING SITE and REFERENCE BODY SITE. For all the human subjects, this difference might not be the same, right?
For example, axillary temp is recorded 0.7C lower than core temp; however; no uncertainty of this value is ever provided. Might this also be the reason?
You are correct.
The temperature measuing site has been forehead, wrist, underarms, under the tongue, rectum and the technology has been from human feel to mercury in capillary type thermometer to digital thermometer to thermometer probe of patient monitor to now IR thermometer.
 
#8
You are a medical device manufacturer, correct?
Do you have a design history file?
In your design history file, do you have customer requirements and design requirements documented? You are required to have this if you are following ISO 13485. See sections 7.2.1 Determination of requirements related to product and 7.3.3 Design and development inputs.
Thanks a lot. I didn't notice the support from ISO 13485 before, and customers did require the spec to be competitive with other benchmark device's.
And in ISO 80601-2-56, there's such statement: "This document requires both clinical VALIDATION and laboratory VERIFICATION for all types of ADJUSTED MODES (of clinical thermometer) ." Then what's the difference in between VALIDATION and VERIFICATION?

So....., here's my simple thoughts,

Is that clinical accuracy should be validated, to get value in a correct way?
There might not be acceptance criteria defined by ISO standards, we only need to meet customer's requirement.

And that laboratory accuracy must be verified, to get the correct value?
There is indeed acceptance criteria defined by ISO standards, we need to follow that.
 
#9
You are correct.
The temperature measuing site has been forehead, wrist, underarms, under the tongue, rectum and the technology has been from human feel to mercury in capillary type thermometer to digital thermometer to thermometer probe of patient monitor to now IR thermometer.
Thank you for your reply, I'm still looking for reasons for the uncertainty of physiological offsets in different body sites, and how the uncertainty is harmonized with the ISO standards.
 

somashekar

Staff member
Super Moderator
#10
Thank you for your reply, I'm still looking for reasons for the uncertainty of physiological offsets in different body sites, and how the uncertainty is harmonized with the ISO standards.
I am not sure if ISO has researched on this toipc and harmonized within its standards.
Please do check if the attahed article will be helpful to you.... Thanks
 

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