Cinnaminson, NJ, January 9th, 2012 -- Last year, it was reported that the deaths of 11 people, including a 2 year old Houston boy that died of an infection, were linked to microbial contamination issues with medical wipes. The infection, caused by a type of bacteria, resulted in the recall of tens of millions of pads and swabs.
One of the companies involved with manufacturing the wipes has recently been given the Food and Drug Administration’s (FDA) approval to begin the first step in reopening their manufacturing process. The FDA reported that they have approved a “reconditioning plan” submitted by the Wisconsin business as part of a court order that was put in place last June.
The wipes, used in hospitals and clinics and distributed to stores for consumption in homes, were not the only ones recalled last year. A New York manufacturer recalled five different types of non-sterile alcohol prep pads because of potential contamination with Bacillus cereus. Also last year, an Arkansas firm recalled baby wipes due to possible contamination with Enterobacter gergoviae.
EMSL Analytical, an FDA registered lab, has been helping manufacturers for years to ensure that their products are safe for consumption or use. “Sterility testing can help prevent tragic cases like the deaths caused by the bacterial contamination of wipes last year,” reported Diane Miskowski, MPH, Business Development Manager at EMSL Analytical. “Manufacturers, regulators and even the general public have access to EMSL’s analytical services to identify potential sterility problems. EMSL’s expert staff has the expertise and advanced instrumentation, clean rooms, and isolators necessary to rapidly indentify issues in the manufacturing process to help ensure that the safest products possible reach consumers. Failure to prevent these types of problems can lead to illnesses and deaths, manufacturers facing lawsuits, and even FDA plant closures. From stability or end-of-use testing, contamination source tracking to sterility and cleaning validation, EMSL can help.”
About EMSL Analytical, Inc.
EMSL Analytical is a nationally recognized and locally focused provider of quality environmental and materials testing services and products to professionals and the general public. The company has an extensive list of accreditations from leading organizations as well as state and federal regulating bodies.