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CDC Says New Vaccine Storage Guidelines Not Mandatory
By Matt Brown
The CDC's new interim vaccine storage and handling guidelines are just that -- guidelines.
According to Kris Sheedy, Ph.D., associate director of communication science at the CDC's National Center for Immunization and Respiratory Diseases, there is no deadline attached to the update and nothing will be enforced.
"These recommendations are in effect now, and … this is interim guidance, not a regulation," Sheedy said.
The CDC issued the update Oct. 5, recommending that physicians store vaccines in full-size, freezerless refrigerators that constantly monitor temperature via a digital, 24-hour temperature-recording device.
"This guidance is intended for use by all public and private sector providers and, while recognizing that cost may be a barrier, we encourage practices to move toward implementing these recommendations as soon as possible," the CDC said in the report. "CDC is currently evaluating the most efficient and cost-effective method to phase these recommendations in, and more guidance is forthcoming."
The impetus behind improving the way providers around the nation store and handle vaccines came from a National Institutes of Standards and Technology (NIST) study (59-page PDF; About PDFs) that found several areas lacking in terms of proper storage.
To correct the problems, the CDC is now recommending that providers use
The CDC issued the update Oct. 5, recommending that physicians store vaccines in full-size, freezerless refrigerators that constantly monitor temperature via a digital, 24-hour temperature-recording device.
"This guidance is intended for use by all public and private sector providers and, while recognizing that cost may be a barrier, we encourage practices to move toward implementing these recommendations as soon as possible," the CDC said in the report. "CDC is currently evaluating the most efficient and cost-effective method to phase these recommendations in, and more guidance is forthcoming."
The impetus behind improving the way providers around the nation store and handle vaccines came from a National Institutes of Standards and Technology (NIST) study (59-page PDF; About PDFs) that found several areas lacking in terms of proper storage.
To correct the problems, the CDC is now recommending that providers use
- stand-alone refrigerator and freezer units suitable for vaccine storage rather than combination (refrigerator/freezer) models not designed for storing fragile biologics;
- biosafe, glycol-encased or similarly temperature-buffered probes;
- digital data loggers with detachable probes that record and store temperature information at frequent programmable intervals for 24-hour temperature monitoring; and
- a weekly review of vaccine expiration dates and rotation of vaccine stock accordingly.
In addition, the CDC also is asking providers to discontinue use of dorm-style or bar-style refrigerator/freezers for even temporary vaccine storage.
Before beginning the NIST study, researchers toured seven clinics enrolled in the CDC's Vaccines for Children (VFC) program to observe common vaccine storage practices. The VFC, which vaccinates 90 percent of U.S. children, came under fire earlier this year when an HHS Office of the Inspector General report (52-page PDF; About PDFs) suggested inappropriate storage and faulty documentation among VFC participants was common.
Jamie Loehr, M.D., of Ithaca, N.Y, a VFC provider and the AAFP liaison to the CDC's Advisory Committee on Immunization Practices, said the CDC's new recommendations are sound.
"I am actually in the process of going out there and looking at what I need to buy," he said. "This is not a requirement by the CDC, but I do believe this is the way vaccine providers should be going."
For providers looking to upgrade their equipment, the CDC has posted a refrigerator buying guide (2-page PDF; About PDFs).
Sheedy said that the CDC's updated Vaccine Storage and Handling Toolkit currently is in the final approval stages, but should be cleared soon.
Before beginning the NIST study, researchers toured seven clinics enrolled in the CDC's Vaccines for Children (VFC) program to observe common vaccine storage practices. The VFC, which vaccinates 90 percent of U.S. children, came under fire earlier this year when an HHS Office of the Inspector General report (52-page PDF; About PDFs) suggested inappropriate storage and faulty documentation among VFC participants was common.
Jamie Loehr, M.D., of Ithaca, N.Y, a VFC provider and the AAFP liaison to the CDC's Advisory Committee on Immunization Practices, said the CDC's new recommendations are sound.
"I am actually in the process of going out there and looking at what I need to buy," he said. "This is not a requirement by the CDC, but I do believe this is the way vaccine providers should be going."
For providers looking to upgrade their equipment, the CDC has posted a refrigerator buying guide (2-page PDF; About PDFs).
Sheedy said that the CDC's updated Vaccine Storage and Handling Toolkit currently is in the final approval stages, but should be cleared soon.
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