The Food and Drug Administration is facing questions from two U.S. senators who wondered why the FDA failed to take public action over manufacturing sterility and contamination problems at Triad Group despite the FDA's knowledge of the issues dating back to mid-2009, according to a news release from the senators.
The Triad Group and parent company H&P recently recalled millions of medical products due to contamination and sterilization problems in the manufacturing process. Media reports suggest the FDA knew about the product's problems in July 2009 but did not take any corrective action until Nov. 2010 when physicians at the Children's Hospital in Denver alerted the FDA to a link between patient infections and Triad Group products.
Triad Group and H&P has recalled lubricating jelly found to be unsterile and recalled alcohol prep products, including swabs, wipes and pads products, which were found to be contaminated by the bacteria Bacillus cereus.
In a letter to the FDA, the senators — Michael Bennet (D-CO) and Lamar Alexander (R-TN) — are urging the FDA to carefully review its oversight of medical product manufacturing to ensure that manufacturers comply with the voluntary compliance measures suggested by inspectors.
Read the news release about the letter to the FDA about the contaminated products.
Read more about infection:
- Johns Hopkins Study: Electronic Faucets Unsafe for Use in Hospital Setting
- Infection Outbreak at Alabama Hospitals Leads to 9 Patient Deaths
- Florida's All Children's Hospital Contacts Patients After Employee Dies From Infection
