NEW ORLEANS – Beginning in 2013, vaccines will need to be stored in a full-sized, freezerless refrigerator, the temperature of which is constantly monitored by a digital 24-hour temperature-recording device.
The new storage guidelines, issued in early October by the Centers for Disease Control and Prevention, also require the use of a biosafe glycol-encased temperature probe because these devices more accurately approximate the temperature of stored liquids, Dr. Herschel Lessin said at the annual meeting of the American Academy of Pediatrics.
The regulation will go into effect on Jan. 1, 2013, said Dr. Lessin, a pediatrician in group practice in Poughkeepsie, N.Y.
Dr. Herschel Lessin
"You also won’t be able to use a dormstyle refrigerator or a refrigerator/freezer combination," he said. "In these units, the freezer is actually what chills the fridge, and when the freezer cycles on and off, it can change the temperature of the refrigerator."
The 24-hour data recording of temperature is intended to ensure that vaccine remains within its constant recommended range of 35°-46° F. "If the data logger hits outside that range, it’s the kiss of death for your store of vaccine," he said.
The recording unit has to be able to store at least 4,000 readings so it won’t overwrite old data or stop recording because the memory is full.
In addition to the hardware changes, human systems will need an update, said Dr. Lessin, who is also a member of the AAP committee on practice and ambulatory medicine. Someone in the office needs to review the temperature log daily. "You have to have a system that if the temperature gets close to being out of the range, you get that vaccine out of there and into an appropriate storage container."
The system should also include a weekly review of expiration dates to facilitate stock rotation, and people who can serve as "vaccine coordinators." These staffers should be trained in proper vaccine storage and handling, and be able to perform accountability checks to make sure the protocol is followed.
In writing the new recommendation, the CDC relied on a 2010 study on refrigerator types and how they can affect vaccines. The study tested two types of refrigerators – household and dormstyle. After 19 thermometer-recorded temperatures in different parts of the devices and on the outside of vaccine bottles were taken, a regular full-sized freezerless refrigerator was found to be "fully adequate" at keeping the vaccines at the optimum temperature. Dormstyle units showed quite a lot of temperature drift, especially when they were heavily loaded. "These problems make the dormitorystyle refrigerator unsuitable for vaccine storage," Dr. Lessin said.
Dr. Lessin said he had no relevant financial disclosures.