— A quarter of the nation’s Veterans Health Administration medical centers and the agency's outpatient mail-order pharmacy used recalled alcohol prep pads and other products blamed in lawsuits for infections and a death, msnbc.com has learned, prompting a new round of concerns from a U.S. senator.
Sen. Michael F. Bennet, D-Colo., on Monday asked Veterans Affairs officials to explain the impact on veterans of hundreds of products manufactured by the Triad Group and H&P Industries Inc. of Hartland, Wis., and included in massive recalls because of the threat of bacterial contamination.
“Were any veterans, in Colorado or other states across the country, affected or injured by these products?” Bennet wrote in a letter to Dr. Robert A. Petzel, under secretary for health at the VA.
Bennet, along with Sen. Lamar Alexander, R-Tenn., had previously questioned the federal Food and Drug Administration’s handling of problems with contamination and sterilization at the Wisconsin plant. Those issues eventually led to the recall of hundreds of millions of products used in hospitals, clinics and homes and widely sold in grocery and drug stores.
Until now, however, there has been no word about specific hospitals that might have used the wipes. Triad Group officials refused to release a comprehensive list and FDA officials said they couldn’t disclose the information because it was proprietary.
Wipes found in 38 of 152 medical centers
Thirty-eight of the country’s 152 major veterans medical centers in 30 states and the District of Columbia removed recalled wipes, pads and other products from use, VA officials told msnbc.com. See the box below for a complete list. In addition, the products were removed from the Consolidated Mail Outpatient Pharmacy, which provides more than 97.4 million prescriptions a year to veterans.
In all, about 1,500 boxes of products were removed, according to Michele Hammonds, a spokeswoman for the VA.
So far, no infections tied to the products have been detected among veterans, Hammonds said in a statement.
That includes infections from Bacillus cereus and Elizabethkingia menigoseptica, two kinds of bacteria implicated in voluntary recalls that led the federal Food and Drug Administration to seize more than $6 million of the Wisconsin firms’ medical products last month.
“We have no record of either at this time,” Hammonds wrote.
The original recall has expanded 40 times since it was issued in January, Hammonds wrote, as Triad Group products were detected in other products such as suture kits that involved additional brand names.
At least one veteran, however, said he’s been using alcohol prep pads supplied by the VA for three years, and that officials only warned him to stop in a form letter included in a medical kit dated April 7, three months after the initial recall was issued.
“I just got a letter a few weeks ago,” said Duane Caseday, 55, of Vancouver, Wash. “Nobody said anything about don’t use the wipes.”
Caseday, who has multiple sclerosis, receives Betaseron injection kits from the Portland, Ore., Veterans Affairs Medical Center pharmacy. In late January, he developed serious infections that required repeated hospital stays. The FDA issued the first recall for Triad alcohol wipes on Jan. 6; Bayer HealthCare posted an online warning about the Betaseron kits on Jan. 8.
When Caseday’s wife, Ginny, saw reports of problems with Triad Group alcohol prep pads on the Internet, she got scared.
“I had no idea the alcohol swabs were contaminated,” said Ginny Caseday, 50. “We had a whole cupboard of them.”
Lab reports show that Caseday’s infection was caused by E. coli and staphylococcus bacteria, but didn't detect the specific germ blamed for infections in at least three lawsuits. The most serious lawsuit claims Triad Group products caused the death of a Houston toddler who developed bacterial meningitis caused by Bacillus cereus, the same organism found in the recalled alcohol prep pads.
VA officials had no immediate comment about when they notified veterans about the recall.
Plant remains closed
H&P Industries’ Hartland, Wis., plant remains shuttered while an FDA investigation continues, a company spokeswoman said. In the weeks since the FDA asked U.S. Marshals to seize a wide range of medical and personal care products, Triad Group and H&P products have been cited as the reason for recalls of first aid kits and animal care products.
In addition, Smith & Nephew Inc. has recalled medical adhesive wipes and adhesive remover manufactured by H&P Industries because of possible contamination with Bacillus cereus.
In addition to lawsuits charging personal injury, H&P Industries has been sued by Medikmark Inc., a Delaware firm that bought a variety of medical products from the company. Medikmark representatives allege that H&P Industries officials knew or should have known products were contaminated and sold them anyway.
Colorado has a special interest in the case because researchers at The Children’s Hospital in Aurora were the first to find a link between life-threatening bloodstream infections in children and Triad wipes contaminated with Bacillus cereus.
Bennet said he wants more information from the VA about how the recall of potentially contaminated products may have affected patients.
“VHA medical facilities provide quality medical care that is tailored to the needs of those who have sacrificed much for our country,” Bennet wrote. “For that very reason, I look forward to working with you to ensure that any recalled Triad products do not have adverse effects on our nation’s veterans.”