NEW: RI Nurse Violated Recall of Potential Fungal Meningitis Meds
Wednesday, December 05, 2012
Injectible pharmaceutical products potentially contaminated with fungal meningitis were kept in patient examing rooms by Skin Essentials Spa in North Providence, according to the RI Dept. of Health. Photo: Centers for Disease Control.
Gerald Dornhecker is a Nurse Practitioner with prescriptive privileges, who worked as a nurse at Skin Essentials Medical Aesthetics and Wellness Spa on Mineral Spring Avenue, according to documents filed with HEALTH. Karen Grande, MD is the Medical Director of Skin Essentials Spa.
Recall of contaminated products in October
On October 4, 2012, New England Compounding Center (NECC) in Massachusetts issued a voluntary recall of pharmaceutical products from its Framingham, MA, facility that may be contaminated with fungal meningitis. The recall instructed customers to immediately "segregate and quarantine" the recalled materials and notify NECC for its return. According to HEALTH, Dornhecker signed the voluntary recall response form and checked a box indicating that "We do not have any of the below products in the facility."
Violations on two separate occasions
However, when the United States Food and Drug Administration conducted a Recall Audit Check 20 days later and was told by Dornhecker that Skin Essentials "did not possess any NECC products," further questioning provoked a change in the story. Dornhecker admitted that he did have possession of NECC products and produced some. "A simultaneous inspection revealed multiple NECC products, which were not quartined or segregated, and were present in exam rooms," according to HEALTH.
About a month later in late November, investigators from HEALTH conducted another examination for recalled NECC products and found multiple products that had been recalled, again in patient exam rooms and again, not quarantined or segregated.
Dornhecker's license has been suspended pending further order. Grande has been ordered to cease and desist from the use of any products recalled by NECC in the October recall and to immediately segregate and quarantine any remaining products for appropriate disposal by HEALTH, notify any and all patients who've been treated by these products.
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