POST 00293 : FREEZE WATCH INDICATORS, EXPIRY DATES & USE

Post00293 FREEZE WATCH INDICATORS, EXPIRY DATES & USE 27 October 2000 CONTENTS 1. FREEZEWATCH EXPIRY DATE AND USE OF FREEZEWATCH INDICATORS WHO and vaccine manufacturers warn against freezing of DTP, DT, Td, TT, Hb, HIB and other liquid vaccines. Recent data suggests that temperatures below 0'C will damage pertussis vaccine. Considering risk of damage to HepB vaccine in sub-zero storage - a vaccine coming into wide routine use - action to prevent freezing and to identify vaccines exposed to freezing is essential. Our concerns have been increased by continued reports from colleagues and personal observations of frozen vaccine in many of health facilities recently visited. * The FreezeWatch? Indicator is a passive device that provides a visual indiction that a freezing event has occurred. Product Information Sheets for FreezeWatch? and STOP!Watch Refrigerator monitor [PIS E6/45, E6/46] are at end of this posting for reference. The FreezeWatch? Indicator is our tool to alert us that vaccine freezing conditions have occurred. To summarize discussion below: * FreezeWatch? Indicators have very short shelf life of 2.5 years from date of manufacture. * Expiry Date is poorly marked * There is little understanding of actions to be taken when FreezeWatch Indicates that a freezing event has occurred. discussion below includes contributions from Jens Pake, WHO/ATT, Karl- Heinz Romann, 3M - Medical Specialties, and Anthony Battersby, FBA Analysts. Actions that should be taken after a FreezeWatch? indicates a freezing event are discussed by Allan Bass, Technet Moderator, and Anthony Battersby, FBA. This discussion was initiated by Moderator during a visit to Sultanate of Oman. Many thanks to Oman National Immunization Program Manager, Dr. Salah Al Awaidy, and his staff for raising questions. No frozen DPT or TT vaccine was found during our visits in Oman. Frozen Hepatitis B vaccine is an unanswered question. The discussion of Low temperature Protection continues next week. Date: Mon, 28 Aug 2000 14:29:15 +1000 To: [[email protected]][email protected][/email] From: Allan Bass Subject: FreezeWatch Indicators Dear Jens, Could you check on this for me please: Oman has a lot of FreezeWatch? indicators - PyMaH Corp, NJ 08822 USA, o'C, Catalog no: 9805. With a batch no(?) FW50426 - and an expiry date 10/97 IT seems to me that expiry date is unreasonable or not applicable. indicators I've tested seem to Break properly at approximately 0'C. * What does expiry date mean? regards and thanks in advance, allan --- Date: Wed, 30 Aug 2000 To: Allan Bass From: [[email protected]][email protected][/email] Subject: Re:FreezeWatch Indicators Dear Allan, For second day I have been in contact with "Berlinger & Co. AG" of Switzerland. They said: "Usually freeze watch indicators are ok even 2 years after exp. date, but at users risk." I asked: "What's life from date of manufacture?" They believe it's about 2 years, but PyMah Corp would not tell them. I have told Berlinger that I cannot accept that answer and that they should try again. They promised they will. However, if Oman FWs were stored under "normal condition" (I guess not too hot and humid) and if Oman's test a FW every now and then - I would not hesitate to use 97 FWs. Best regards Jens --- Date: Wed, 30 Aug 2000 12:18:14 +1000 To: [[email protected]][email protected][/email] From: Allan Bass Subject: Re:FreezeWatch Indicators Dear Jens, Thanks. Yes - please let me know. reply really does not make a lot of sense. All are stored under air conditioning or in refrigerators. regards and thanks, allan ___________________________________________________________________________ Jens Pake, WHO/ATT, kindly followed up on this request and discussed it on telephone with Karl-Heinz Romann, at 3M Europe. 3M has taken over FreezeWatch indicator production. delay in emails was due to leave. ___________________________________________________________________________ From: [[email protected]][email protected][/email] Date: Thu, 28 Sep 2000 Subject: Re:Tel. call, Shelf life, FreezeWatch To: [[email protected]][email protected][/email] Cc: [[email protected]][email protected][/email] Dear Mr. Romann, With reference to your last email and our telephone conversation late August 00. I have looked around here at WHO for samples of freeze watch indicators and found some "old" ones. None of indicators have an expiry date printed on. How is it with indicators produced nowadays. Do they have a date printed? If not I belive it must be a requirement that all indicators have expiry date printed clearly in order for user to verify if product is ok or not. whole idea of spending money on vaccine safety methods is falling apart if there is no expiry date on product. But, it is even worse when users are unaware that indicators has a limited lifetime. Users might use too old (useless) indicators in good faith, not knowing that their vaccine has been damaged. We would be grateful if you could send us a sample to: WHO-HTP V&B, ATT Attention Jens Pake 20 Avenue Appia CH-1211 Geneva 27 Switzerland Best regards Jens Pake --- From: [[email protected]][email protected][/email] Sent: Thursday, September 28, 2000 5:09 PM To: [[email protected]][email protected][/email]; [[email protected]][email protected][/email]; Cc: [[email protected]][email protected][/email] Subject: Re: Fwd:Re:Tel. call, address, Shelf life, FreezeWatch Dear Jens, Karl-Heinz, and Debbie, Thanks! I'm not sure that I understand FreezeWatch aging failure mode. Sealed in glass, it seems as if it would be fairly stable. You might also note that on FreezeWatch? sheets of 12 indicators (I think) that I saw in Oman recently - (1997 expiry) only centre indicator had expiry date stamped on it back - once indicators were separated - only one had expiry date. And after being applied with adhesive back - no expiry date. * I would like to prepare a Technet posting on FreezeWatch? - partly because of expiry date issue - but more because of my recent field experience. UNICEF in one country/region (at least!) is arguing against use of FreezeWatch in refrigerators - on simple basis of: " What do you do? Throw vaccine out? " I can think of three actions in event of a FreezeWatch indication a of freezing event: My comments below on actions to be taken after a freeze watch indicates a freezing event below apply to HepB vax - where shake test is much more difficult to apply. (you can use shake test using a strong lens on 1 or 2 dose vials - examining vial shoulder for particulates - and shake test is a more reasonable procedure on 10 dose vials.) For DPT, DT, and TT vaccines shake test should always be used before dispensing and administering it to a client, regardless of any FreezeWatch indication. * Three actions when a FreezeWatch? indicates a past freezing event with HepB vaccine. 1. If vaccine quantities are small - less than 10 to 20 vials vials - yes throw out vaccine and check refrigerator loading, re-adjust refrigerator thermostat, and ensure that ice packs are warmed to 0'C before use in vaccine carriers and in transport boxes. 2. Monitor frequency of freezing events. If freezing events are frequent or increase in frequency - cold chain equipment and procedures need examination and action to reduce problem. There are examples of programs reducing problem from nearly 40% of vaccine being exposed to freezing to less than 5% - by improved vaccine handling and management. 3. If vaccine quantities involved are large, sequestering vaccine and potency testing/assay would be needed. Clearly there is a lot of confusion in donor agencies and in country programs. * This is a critical issue - with large quantities of HepB and more freeze sensitive HIB vaccine entering vaccine cold chain around world. Your thoughts and help with this discussion is appreciated. regards, allan --- Date: Sun, 1 Oct 2000 07:00:23 -0400 From: Anthony Battersby