The FDA in July raised concerns over cleanliness and sterilization during an inspection at a New Jersey company which had a batch of its ultrasound gel seized by federal agents Wednesday because the FDA says tests showed it was tainted with dangerous levels of bacteria and which may have infected babies in a neonatal intensive care unit (NICU).
In a warning letter in September, FDA investigators said that Pharmaceutical Innovations did not test product adequately to ensure it was sterile and did not make sure equipment used to sterilize the product was properly maintained and calibrated.
The letter also says Pharmaceutical Innovations did not thoroughly investigate a complaint that babies in a NICU were infected by Pseudomonas. "The hospital's investigation led to culturing your ultrasound 8 oz bottles and 5 liter gel which tested positive for the Pseudomonas organism." The company told the FDA the hospital had not properly used the product but failed to establish a procedure to make sure that same thing didn't happen again.
U.S. Marshals seized all lots of Other-Sonic Generic Ultrasound Transmission Gel manufactured by the Newark, NJ, company Wednesday that are believed to contain dangerous levels of bacteria.
The FDA says that 16 patients on whom the gel was used during surgery have gotten sick. In an email today, FDA spokeswoman Sarah Clark-Lynn said the 16 patients were at a hospital in Michigan. They developed colonization or infection with the bacteria Pseudomonas aeruginosa after undergoing cardiovascular surgery. As a result of the ongoing investigation, the hospital tested both open and closed ultrasound gel. Testing by the hospital confirmed Pseudomonas aeruginosa in both opened and unopened bottles.
The FDA was contacted on Feb. 15 by the State Department of Health, where the infections occurred. There was also a MedSun Adverse Event Report submission on March 2, she said.
Tests on the product in February revealed unsafe levels of two bacteria: Pseudomonas aeruginosa and Klebsiella oxytoca, the FDA says, citing a filing in the U.S. District Court in New Jersey.
The product, manufactured by Pharmaceutical Innovations, was seized at the company's operations in Newark and has been embargoed by the New Jersey Department of Health and Senior Services at FDA's request.
"This ultrasound gel presented serious health risks to patients, particularly vulnerable ones," said Dara A. Corrigan, the FDA's associate commissioner for regulatory affairs, in the release. "Therefore, FDA, with the assistance of our state partner, is taking aggressive enforcement action to protect the public health."
Gilbert Buchalter, president of the company, initially played dumb when asked about the raid, and then said he had no comment. An office worker, who declined to be identified, acknowledged agents had been to the facility.
The affected gel products include 250 milliliter and 5 liter containers of Other-Sonic Generic Ultrasound Transmission Gel manufactured from June 2011 through December 2011.
- here's the FDA release
- check out the warning letter