The recent meningitis outbreak has raised many concerns about vaccine storage, handling and the concept of "quality control" in medicine. The recent news in the scandal has several individuals suing the New England Compounding Center, the lab responsible for the alleged outbreak. The aftermath of legal issues will likely continue for months, but the violated procedures and the contamination of supposed "sterile" vials is a larger concern for any vaccine storage and handling facility.
There is much to be concerned about, the welfare of the affected individuals is the most important issue. But as we open the umbrella a bit further, we hope that all private and public health clinics are following the new guidelines recommended by CDC in October. Varying temperatures and inaccurate monitoring in vaccine storage can be extremely dangerous, and according to the CDC, an estimated 17-31% of (vaccine) providers expose vaccines to improper storage temperatures. The statement that inadequate temperature control and monitoring played a role in the oubtreak is mere speculation, but a viable possibility nonetheless.
A report in June documented the problems over vaccine storage and temperature control for the Vaccines for Children (VFC) program. It's an unfortunate story to uncover, as the current Meningitis outbreak has come only two months afterwards. As released by the Office of Inspector General, the report noted that up to 75% of VFC vials had been exposed to irregular temperatures.
Although the root causes have yet to be uncovered, the Commonwealth of Massachusetts has also released their Preliminary Investigation Report, documenting many of the violations of the facility. In a not-so-appetizing note, the FDA states that black particulate matter was seen in a sterile vial. The DPH and FDA also made the preliminary statement that the matter was "fungal contamination", though again, the source and cause of the matter is still under a full investigation.
As Temperature@lert keeps this outbreak on our radar, we'd like to direct you to the homepage for the Meningitis outbreak.You'll find useful information, updates, and state-by-state reports on the outbreak. The updated CDC Vaccine storage and Handling guidelines are important to abide by, and we ensure that Temperature@lert products are tested, certified and suitable for use in vaccine storage and handling.
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