Monday, 08 May 2000
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Post00250 Product Info Sheets - 2000 8May 2000 CONTENTS 1. COMMENT RE: Post00242 PIS 2000 2. PROPOSED CHANGES TO PIS E3 FAMILY 1. COMMENT RE: Post00242 PIS 20001 In TECHNET Forum Post00224, Anthony Battersby, FBA, raised a number of issues relating to the ongoing revision of the Cold Chain Equipment Product Information Sheets. Hans Everts, WHO/V&B/EPI, replies. From: [[email protected]][email protected][/email] Date: Mon, 17 Apr 2000 12:20:48 +0200 To: Subject: RE: Post00242 PIS 2000 Dear Allan, If many people agree with Anthony, that the sheets should not be simplified, that would save us a lot of work. However, there is more to it. Anthony argues that the lines we propose to remove are needed for decision makers. If that was true, I would never consider taking them out, but our point is that even if the decision maker had the full test reports, those lines would still give very incomplete and misleading information. For example, the internal temperatures. A refrigerator with continuous and more or less stable temperatures of 3?C, but with short peaks of 8?C, will have 8?C indicated as maximum temperature. An appliance that runs constantly at 7?C will have that as maximum temperature. Which one is the best for vaccine storage? I think the first one, but the main point is that they both passed and comply with the standards. In addition the temperatures are recorded under strictly controlled laboratory conditions. They give a relative, but not an absolute indication on how the appliance will function in the field. In other words, it would be a mistake to think that an appliance with a 4?C recorded temperature is by definition better than one that recorded 6?C. In other words appliances that pass the test are good enough to store vaccine and the others are not. Within the group that passed the choice should not be based on test results, but on other specifications like storage volume, energy source, temperature zone, etc.. Anthony, I do suggest you have another look at the proposed sheet and at the PIS. Different voltages were not removed, but put under the more logical heading 'Energy requirements'. There is a glossary in the PIS (page XX). As was said in previous messages, most warnings will disappear due to the combined effect of the introduction of temperature zones and the change of specifications (and/or the way they are applied). Warnings are hardly read and making them clearer will not change much. We have quite some reports on the E3/89 and 90, mostly negative. We are following up on this with UNICEF and the manufacturer. The appliance passed the tests and was designed for temperatures up to 32?C. It failed at 43?C. More feedback from the field would be useful. Readers are invited to send it to us and Angus Pringle in UNICEF Copenhagen. Hans Everts Technical Officer EPI WHO Geneva Tel: 00 41 33 791 3863 ____________________________________*______________________________________ 2. PROPOSED CHANGES TO PIS E3 FAMILY Paul Mallins, WHO/V&B/EPI has posted draft Product information sheets for the E3 family of the PIS - 2000 revision for comment. The files are available for download at: ftp://ftp.acithn.uq.edu.au/Technet/1-ClickHereForTECHNETfiles/PIS-2000 E3-proposed-format-27.03.00.doc E3-current-format-27.03.00.doc Or send an email to: [[email protected]][email protected][/email] with the message: get technet E3-proposed-format-27.03.00.doc get technet E3-current-format-27.03.00.doc From: [[email protected]][email protected][/email] Date: Tue, 02 May 2000 09:56:13 +0200 To: [[email protected]][email protected][/email] Subject: Proposed changes to PIS E3 family Dear All, Please find attached an example sheet for the proposed revision of the E3 family format. The current format is posted for comparison. The changes are: - Removal of internal and day night temperatures from Performance section - Movement of energy info from Comments to Energy section - Removal of statement that appliance is CFC free - Movement of cooling refrigerant info from Comment to Specs section The proposed changes are aimed at simplifying the sheets by taking away info that does not assist the decision making process and secondly to move information to a more logical section. Allan, we thought final comments from this expert group would be useful before the final decision is taken. Your comments will be gratefully received. Thanks and best regards Paul Mallins ____________________________________*______________________________________
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