POST 01068E : TEMPERATURE MONITORING DEVICES INTERPRETATION
23 March 2007
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Dear all,
According to WHO Guidelines on the international packaging and
shipping of vaccines (WHO/IVB/05.23) a 10-day electronic temperature
monitoring device should be included in each international vaccine
shipping carton. Ten-day electronic temperature monitoring devices
show when, and to what extent, the set temperature conditions have
been violated. There are two different types of devices. Type 1 with
YELLOW backing card is for DTP, TT, DT, Td, HepB, IPV, liquid Hib and
combination vaccines while Type 2 with BLUE backing card will be for
OPV, freeze-dried BCG, measles, MR, MMR, Hib, yellow fever and
meningitis vaccines. There are different set alarms in Type 1 and 2 devices.
There has been a series of meetings with PAHO and UNICEF SD for
planning the introduction of electronic devices in international
shipments. Both UNICEF and PAHO will be gradually introducing the
devices in international shipments in 2007. The document at the link
below was produced by Quality, Safety and Standards (QSS) team as
part of a training package that is under development. The document
describes step-by-step what to do when the shipment arrives at the
country level.
http://www.technet21.org/fichiers_Word/TempMonitorInterpretation-Shipments.doc
(2.6 MB)
In addition to this document, an animated PowerPoint presentation
will be released soon. WHO will also print posters of enlarged tables
from the pages 6 and 7 of the document hyperlinked above.
All training materials will be translated into other UN languages.
With the introduction of electronic temperature monitoring devices,
the Vaccine Arrival Report (VAR) is also being modified (see pages
26-28 in the document). In addition to the VAR, an Electronic device
alarm report form is being introduced to be filled in only when
electronic devices indicate an ALARM status (see pages 29-32).
For a smooth introduction, UNICEF and WHO will establish help desk
support to assist recipient countries. WHO is working closely with
UNICEF SD to introduce the devices and their user instructions in
forthcoming regional and global meetings.
An interactive web page on the use of electronic devices will also be
designed at QSS vaccine quality web site in coming months.
If you have any questions, please do not hesitate to contact me directly.
Umit
Dr. Umit Kartoglu, MD, DPH
Scientist
FCH/IVB/QSS,
World Health Organization
Geneva 27, Switzerland
mailto:[email protected]
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