FDA update – March 12, 2011

Under pressure, firm shutters line that made tainted wipes

Cyndi Littlehorn, a microbiologist and senior medical technologist at the Children's Hospital in Aurora, Co. holds a sample of the bacteria Bacillus cereus cultured from alcohol wipes manufactured by the Triad Group of Hartland, Wis. The bacteria caused life-threatening infections in children that sparked a nationwide recalls of Triad alcohol prep products.  Bacillus cereus bacteria are common in the environment and sometimes associated with foodborne illness, but not usually with medically acquired infections. The bacteria form hard-to-kill spores can survive heat and the 70-percent alcohol solution used in the wipes.

A Wisconsin medical supplier that made millions of recalled alcohol prep products is shutting down the line that produces the wipes.

• Triad officials made the move voluntarily and did not notify the FDA about their plans to halt production of alcohol prep products because of potential contamination.
• Company will continue to operate its divisions that produce other medical supplies and hygiene products, including suppositories, children’s cold medicines and mouth washes and rinses.
• Triad will also stop production of sterile lubricating jelly.
• FDA has issued no sanctions against Triad, despite government documents that identified ongoing problems with contamination and sterilization at the Triad plant.
• FDA officials said they were working with the firm to make voluntary improvements because there was no “imminent health hazard”
• Since the recall, the FDA has received 161 reports of adverse events related to alcohol prep wipes, including three deaths, which don’t appear to be related to Triad products
  

FDA Inspectors found:

• microbial contamination of water pipes leading to vats that made batches of blue and yellow mouth rinse and glycerin suppositories,
• employees were packing acne pads into containers with their bare hands
• A worker who failed to add the active ingredient to a batch of children’s multi-symptom cold medicine.
• who were testing the finished drug products lacked the education and background to do the job.
• Company had too few employees to supervise the manufacture, processing, packing and holding of drug products.
• Employees could not speak, read or write English in order to sign off on finished products in the warehouse.
• FDA inspectors detected microbial contamination in both wipes and jelly, and problems with validation of Triad's sterilization process.
• FDA inspectors who verified contamination in wipes and lubricating jelly also detected problems with a wide range of Triad medical and hygiene supplies.

The FDA scrutiny on these antimicrobial wipes and hand lotions is becoming more apparent with several recalls because of microbial contamination. Though the label may say that the product is anti-microbial, it has to be manufactured and tested to be safe and effective for it’s labeled use. These products, though look simple can be involved with many health incidents.

If there are any questions on these new Industry Update please contact us via email at info@mdiconsultants.com and Ref: Tainted wipes.