Delaware Health Alert Network #285
November 7, 2012 9:05 am
Health
Alert
CONTAMINATION OF ADDITIONAL MEDICAL PRODUCTS FROM NEW ENGLAND COMPOUNDING CENTER (NECC)
The Delaware Division of Public Health is issuing this health alert to provide healthcare providers and facilities with details regarding additional contaminated medical products identified in the ongoing Food and Drug Administration (FDA) investigation associated with the fungal meningitis outbreak. It is unknown whether facilities in Delaware received the lots of contaminated betamethasone or cardioplesia solution.
Background
The Centers for Disease Control and Prevention (CDC) and FDA are reporting that product testing has identified bacterial contamination with several Bacillus species and closely related bacterial organisms in unopened vials of betamethasone and cardioplegia solution that were distributed and later recalled by NECC on October 6, 2012. These bacteria are commonly found in the environment and have been rarely reported as a cause of human disease; it is not known how product contamination with these species might affect patients. CDC has not received reports of laboratory-confirmed cases of infection due to Bacillus or closely related organisms linked to these products.
The following table provides CDC and FDA laboratory testing results for contamination and product lot numbers. Other cultures for these products, including fungal cultures, are pending.
| Medication | Lot number | Microbial contamination |
|---|---|---|
| Betamethasone | 08202012@141 | Paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus sp. |
| Betamethasone | 07032012@22 | Bacillus niabensis, Bacillus circulans |
| Betamethasone | 07302012@52 | Bacillus lentus, Bacillus circulans |
| Cardioplegia solution | 09242012@55 | Bacillus halmapalus, Brevibacillus choshinensis |
Recommendations
- Clinicians should consider these product findings when reviewing laboratory results from patients who have been exposed to a NECC product.
- Do not use any product produced by NECC as previously recommended by CDC and FDA.
- Continue follow-up of patients who received any injectable NECC product, including betamethasone or cardioplegia solution purchased from or distributed by NECC after May 21, 2012.
- For healthcare providers diagnosing and treating symptomatic patients who have received NECC products, CDC recommendations have not changed and can be found at http://www.cdc.gov/hai/outbreaks/clinicians/index.html#Guidance.
Additional Information
- CDC health alert: http://www.bt.cdc.gov/HAN/han00333.asp. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm326370.htm
- Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products online at www.fda.gov/MedWatch/report.htm
- Delaware Division of Public Health, Bureau of Epidemiology (24/7): 1-888-295-5156.
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