This is helpful! I was not worried about going below 2C with door opening, only if the inventory began at 7C (just prior a compressor activation) then it would be relatively easy to get to 9C while the door is open. If by liberalizing the average temp to be "4C or 5C" instead of "5C" we get a cheaper product with economy of scale, I think in the long run more vaccine will be protected. In other words, if a "lab quality" unit set to 4C otherwise passes, I'd hope that could qualify as a vaccine refrigerator. 4C is still a long ways from zero.... -gb Graham Barden MD FAAP DrBarden@xxxxxxxxxxxxxxxxxxxx Coastal Children's Clinic New Bern, NC
www.coastalchildrens.com From: Robert Turnbull [mailto:RTurnbull@xxxxxxxxxxxxx] Sent: Friday, July 08, 2016 11:28 AM To: Dr. Graham Barden; 'Kelly Moore'; 'vs@xxxxxxxxxxxxxxxxx' Subject: RE: [vs] Groups - Temp Change QA 6-27-16 FINAL PDF.pdf uploaded On a typical Lab grade refrigerator you will see about +/- 1C or maybe less for controls. So with a set point of 4C, the average will stay with in 3C to 5C. But it depends on where you are measuring (ie Top, Middle, Bottom) There may be some bigger swings there. Our lab grade units hold +/- 2C in all locations. You might see an increase outside of 2C during defrost for a short period of time (ie 3-5 minutes). I think your concern about pulling down below 2C during a door opening is not there. I have doing a lot of testing with our lab grade units right now and I am just not seeing it. I think we need to make sure the test method covers this with some sort of loaded condition with door openings for certification, but I feel comfortable that we can meet 2C 100% of the time and 8C 99% of the time (ie Door opening). Bob Turnbull Staff Engineer AGA Marvel From: Dr. Graham Barden [ mailto:DrBarden@xxxxxxxxxxxxxxxxxxxx ] Sent: Friday, July 08, 2016 11:07 AM To: 'Kelly Moore'; Robert Turnbull; 'vs@xxxxxxxxxxxxxxxxx' Subject: RE: [vs] Groups - Temp Change QA 6-27-16 FINAL PDF.pdf uploaded Just more thoughts out to the group (and I am fishing for knowledge from the manufacturers...) When a refrigerator is billed as being set at 5C +/-2C, does that means the compressor may turn on at 7C and pull the unit down to 3C and then allow it to drift back up to 7C before turning back on, for an expected range of 4C? Thus yielding an average of 5C? Or do you typically have a tighter/wider range? To yield an average of 5C, what are the usual on/off compressor settings? I just want the group to remember that the CDC "rules" were designed for domestic combo refrigerators to work and domestics don't work! I realize we have to work within the framework that the CDC has set, but some of the advice is nonsensical when applied to purpose built vaccine refrigerators - like the thermometer is to be in the center of the middle shelf and you can have only one, vaccines should be 2-3 inches from the side walls (pharmacy grade circulate air primarily front and back and when you restrict vaccine placement too much, you get crowding and expiry date goofs) and my least favorite graphic by the CDC (attached) where they missed a chance to have purpose units stand out with much larger percentage of acceptable storage. We could pick 5C, but I think 4C or 5C would acceptable if the rule "never colder than 2C as measured with a non-buffered thermometer in all areas of the unit where vaccine can be stored" is not violated. No matter what the design of the unit is, if the practice happens to open the door of the unit to do monthly inventory just before the compressor kicks on at 7C, there is a good chance that the buffered data logger may record a reading over 8C. And we don't have Australian rules where "during active management of the vaccine, excursions of less than 10 min are not reportable...." So this is potentially a hard physics problem! Kelly - my understanding is that if a practice has a max/min reading over 8C, they are supposed to stop immunizing from that unit and call the VFC program for "official dispensation". Is that how your state does it? -Graham Graham Barden MD FAAP DrBarden@xxxxxxxxxxxxxxxxxxxx Coastal Children's Clinic New Bern, NC
www.coastalchildrens.com From: vs@xxxxxxxxxxxxxxxxx [ mailto:vs@xxxxxxxxxxxxxxxxx ] On Behalf Of Kelly Moore Sent: Friday, July 08, 2016 9:50 AM To: 'Robert Turnbull'; 'vs@xxxxxxxxxxxxxxxxx' Subject: RE: [vs] Groups - Temp Change QA 6-27-16 FINAL PDF.pdf uploaded They are fine points of distinction. We will need to be good communicators of the summary of differences when the time comes. Thanks! Kelly L. Moore, MD, MPH Director Tennessee Immunization Program From: Robert Turnbull [ mailto:RTurnbull@xxxxxxxxxxxxx ] Sent: Friday, July 08, 2016 8:47 AM To: Kelly Moore; 'vs@xxxxxxxxxxxxxxxxx' Subject: RE: [vs] Groups - Temp Change QA 6-27-16 FINAL PDF.pdf uploaded Sorry, my bad, 5C it is. Again I have to keep switching between Vaccine storage and General purpose Lab Grade, which is 4C. Bob Turnbull Staff Engineer AGA Marvel From: Kelly Moore [ mailto:Kelly.Moore@xxxxxx ] Sent: Friday, July 08, 2016 9:44 AM To: Robert Turnbull; 'Dr. Graham Barden'; 'Rachel Brooker'; 'vs@xxxxxxxxxxxxxxxxx' Subject: RE: [vs] Groups - Temp Change QA 6-27-16 FINAL PDF.pdf uploaded Robert, Just a question… Quite possible I missed something, but wouldn’t vaccine storage be 5C, not 4C (5C is what is published as recommended by CDC, enforced by the VFC program on all of our temp guides and has been for years). 5C, +/- 3C, was what I recalled because that equals the FDA-labeled 2C-8C range. Kelly L. Moore, MD, MPH Director Tennessee Immunization Program From: vs@xxxxxxxxxxxxxxxxx [ mailto:vs@xxxxxxxxxxxxxxxxx ] On Behalf Of Robert Turnbull Sent: Friday, July 08, 2016 6:31 AM To: Dr. Graham Barden; 'Rachel Brooker'; vs@xxxxxxxxxxxxxxxxx Subject: RE: [vs] Groups - Temp Change QA 6-27-16 FINAL PDF.pdf uploaded *** This is an EXTERNAL email. Please exercise caution. DO NOT open attachments or click links from unknown senders or unexpected email. - STS-Security*** I agree with Graham. But I must say I am a Fahrenheit guy, but I am working on it. We must also start to distinguish between general purpose lab grade and vaccine storage. Lab Grade will still be temperature adjustable, with display, but Vaccine (from what I understand) with be 4C set and NON adjustable. Lab grade will have third party calibrated temperature monitoring. Vaccine Storage is looking at Calibrated refrigerator. (I must say I disagree with this point). Bob Turnbull Staff Engineer AGA Marvel From: vs@xxxxxxxxxxxxxxxxx [ mailto:vs@xxxxxxxxxxxxxxxxx ] On Behalf Of Dr. Graham Barden Sent: Thursday, July 07, 2016 2:54 PM To: 'Rachel Brooker'; vs@xxxxxxxxxxxxxxxxx Subject: RE: [vs] Groups - Temp Change QA 6-27-16 FINAL PDF.pdf uploaded I do wish the CDC would just use Centigrade for temperature and not Fahrenheit. Makes way more sense to "stay away from Zero" as the rule - and "2 to 8" is easier to remember than the old 35-46. At least 36-46 is easier to remember. If we champion using Centigrade, it makes refrigerators seem more special - more scientific - and more distinct from domestic units which report in Fahrenheit. We need to draw as many distinctions between vaccine refrigerators and domestic units as we can! -gb Graham Barden MD FAAP DrBarden@xxxxxxxxxxxxxxxxxxxx Coastal Children's Clinic New Bern, NC
www.coastalchildrens.com From: vs@xxxxxxxxxxxxxxxxx [ mailto:vs@xxxxxxxxxxxxxxxxx ] On Behalf Of Rachel Brooker Sent: Thursday, July 07, 2016 2:24 PM To: vs@xxxxxxxxxxxxxxxxx Subject: [vs] Groups - Temp Change QA 6-27-16 FINAL PDF.pdf uploaded Submitter's message Hello Vaccine Storage JC, Kelly Moore informed me that the CDC has recently published an update to its Fahrenheit measured recommended temperatures, changing from the old 35-46 to the new 36-46 – because they decided that since 2.0C = 35.6F, the old way of rounding down to 35F should not be allowed and in fact we should round up to 36.0F if using the Fahrenheit scale. The 2-8 Celsius scale is unchanged. She sent me this document and I think that it would be useful for everyone to review. Thanks Kelly! Best, Rachel Rachel M. Brooker Standards Development Liaison, Health Sciences NSF International ISO/TC249 US TAG Administrator Email: rbrooker@xxxxxxx Phone: 734.827.6866 -- Rachel Brooker Document Name : Temp Change QA 6-27-16 FINAL PDF.pdf No description provided. Download Latest Revision Submitter : Rachel Brooker Group : Joint Committee on Vaccine Storage Folder : Reference Documents Date submitted : 2016-07-07 11:23:41 This e-mail message may contain legally privileged and/or confidential information. If you are not the intended recipient(s), or the employee or agent responsible for delivery of this message to the intended recipient(s), you are hereby notified that any dissemination, distribution or copying of this e-mail message is strictly prohibited. If you have received this message in error, please immediately notify the sender and delete this e-mail message from your computer immediately without retaining any hard or electronic copies. This e-mail message may contain legally privileged and/or confidential information. If you are not the intended recipient(s), or the employee or agent responsible for delivery of this message to the intended recipient(s), you are hereby notified that any dissemination, distribution or copying of this e-mail message is strictly prohibited. If you have received this message in error, please immediately notify the sender and delete this e-mail message from your computer immediately without retaining any hard or electronic copies. This e-mail message may contain legally privileged and/or confidential information. If you are not the intended recipient(s), or the employee or agent responsible for delivery of this message to the intended recipient(s), you are hereby notified that any dissemination, distribution or copying of this e-mail message is strictly prohibited. If you have received this message in error, please immediately notify the sender and delete this e-mail message from your computer immediately without retaining any hard or electronic copies.