October 3, 2014 — Federal safety officials are trying to shut down a manufacturer of medical gel used in surgery and ultrasounds because the company has failed to fix quality-control problems. Bacterial infections were linked to the products in 2012.
The owners are accused of violating federal law by creating and selling products that do not comply with current good manufacturing practices. The products were also sold without required pre-market approval or clearance from the FDA.
Despite multiple warnings by the FDA over the last three years, and promises to correct problems, the owners have continued to violate the law. This presents serious health risks to patients who are exposed to the company’s products.
In February 2012, a hospital in Michigan traced infections among 16 surgical patients to Other-Sonic Generic Ultrasound Transmission Gel manufactured by Pharmaceutical Innovations. After FDA testing discovered bacterial contamination, they ordered seizure of the products by the U.S. Marshals Service:
Patients who are exposed to bacteria on the surface of their skin could develop inflammatory dermatitis, even on intact skin. Invasive biopsy procedures could also carry bacteria into tissues, causing abscess or sepsis.
The FDA also published a safety communication, warning:
“For example, if Pseudomonas aeruginosa is introduced into the upper airway through a transesophageal echocardiography (TEE) procedure and begins to grow, it may cause no symptoms. However, if it is accidentally aspirated into the lower airway, it could cause tracheobronchitis or pneumonia.”
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