POST 00470E : FREEZE-WATCH ACTIVATION PROBLEM

POST 00470E : FREEZE-WATCH ACTIVATION PROBLEM Follow-up on Posts 00430E, 00453E and 00461E 9 July 2002 _______________________________________________________ In POST 00461E dated 8 June 2002, WHO had informed all TechNet21 subscribers that an investigation has been initiated to analyze reported performance problems of Freeze Watches. It also called on individuals and organizations to report problems directly to WHO (mailto:[log in to unmask]) WHO had also informed that incoming inputs on this subject will not be posted since all will feed into the ongoing investigation. However as soon as the issue is resolved by WHO, the outcome of the investigation will be published to inform all readers. Some individuals and organization have contacted WHO and we thank them for their valuable feedback. However, we have also learned that some individuals (surprisingly TechNet21 subscribers and presumably reading the above mentioned messages) have contacted the manufacturer 3M directly, reporting performance problems they had discovered in the field and asking for replacement of devices. They have managed to get replacement for 400 FWs. It is normal and usual practice to get replacement for any faulty item organizations/individuals had paid for. But what is to be deplored in this attitude is the "lack of responsibility". For an average lot run of around 5-10,000 units of FWs, if quality problems exist indeed, the replacement of 400 units may solve their own problem, but will not help other country offices who have received the same lot but have not discovered the problem yet. Thus we would like to repeat our request with insistence and call for a responsible attitude and cooperation. It is quite important that all organizations and individuals receiving and reading this message inform WHO (mailto:[log in to unmask]) with any performance problems they identify with FreezeWatch in the field. This is critical for the investigation to be successful. Specifically, we would like to know if any other countries besides Kazakhstan, or organizations have received the 9805 model zero degree FWs from the lot number 2005-03-AA. As a temporary measure on 24 May 2002, WHO has recommended to UNICEF Supply Division and PAHO not to purchase the device until WHO resolves this issue. Consequently, UNICEF SD has advised vaccine manufacturers not to use FW in their shipments. We would also like to inform all countries should they receive freeze sensitive vaccines without any FWs, that they have to conduct the Shake Test to check whether vaccines were exposed to freezing temperatures during the shipment, In the case of temperature data loggers accompanying shipments, temperature recordings should be read carefully to clarify temperatures to which vaccines were exposed. For your easy reference the Shake Test procedure is as follows : SHAKE TEST The shake test is most easily demonstrated using a vaccine vial that you personally froze intentionally and do not intend to use for immunization. Once thawed, this vial can be used as the "frozen control sample" to be compared with suspect vaccines (mark this frozen control sample to prevent accidental use and discard it after the test). If the control vial shows much faster sedimentation than in the vial being tested, the vaccine in question is probably potent and may be used. If however, the sedimentation is similar or faster in the vial being tested and contains flakes, then this vial under test should not be used. It is important that the shake test is done using both "test' and "frozen control" vaccine vials produced by the same manufacturer. Test procedure: 1. Take both vials, shake vigorously for 10-15 seconds, 2. Leave vials at rest, and 3. Observe both vials against the light to compare the sedimentation rate. Please note that batches may behave differently, therefore the above mentioned test should be repeated with all batches involved in the shipment. However, it is not necessary to repeat the test for each single shipping box. Thank you for your usual cooperation and understanding. Ümit Kartoglu ----------------------------------------------------------------------------- CONTRIBUTIONS: Contributions to: or use your reply button! The TechNet21 e-Forum welcomes new subscribers who are involved in immunization services. 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