8
Staff Competency Validation
All clinical personnel responsible for performing Jaundice Meter JM-105
testing must be properly trained prior to using the device in a clinical setting.
Training will be completed as follows:
1. Staff responsible for using the Jaundice Meter JM-105 will receive a
demonstration of the JM-105 by an experienced Jaundice Meter JM-
105 operator OR will view the Jaundice Meter JM-105 training video.
Learners are also responsible for reading the information provided in
the Operating Instructions Manual.
2. Learners will perform a return demonstration on three infants in the
presence of an experienced Jaundice Meter JM-105 operator and
complete the attached Skills Checklist.
3. Successful completion of training will be documented in the employee’s
education record.
New or Serviced Device Validation
It is recommended that users validate the Jaundice Meter JM-105 in their
individual patient populations prior to putting it into clinical use. You can do
this by taking transcutaneous bilirubin readings with the Jaundice Meter on
infants who are already scheduled to have blood drawn for serum bilirubin
analysis by the lab. The time gap between the transcutaneous bilirubin
readings and the blood sample should not be greater than one hour.
Record the reading along with the serum bilirubin results from the lab on a
data collection sheet like the one attached to this document.
When you have recorded enough simultaneous jaundice meter readings and
serum bilirubin, you can use this information to develop a protocol for use of
the jaundice meter in your facility.
References
1. Dräger Jaundice Meter Model JM-105 Instructions for Use.
2. E T Schmidt, C A Wheeler, G L Jackson and W D Engle, Evaluation of transcutaneous
bilirubinometry in preterm neonates, Journal of Perinatology 29
: 564-569 March 2009.
3. Management of Hyperbilirubinemia in the Newborn Infant 35 or More
Weeks of Gestation. Pediatrics Vol. 114 No. 1 July 2004
4. Maisels MJ, Kring E. Transcutaneous bilirubin levels in the first 96 hours in a normal
newborn population of ≥35 weeks' gestation. Pediatrics. 106;117(4):1169-117.
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