FDA Tells Doctors to Stop Using Customed Surgical Convenience Packs and TrayJan 11, 2016
After repeated issues with sterility, the U.S. Food and Drug Administration (FDA) is telling health care professionals in Puerto Rico tostop using surgical convenience packs and trays manufactured by Customed Inc. These products contain instruments used during surgical procedures. Items such as exam gloves, suture bags, absorbent towels, surgical table covers and drapes are often included in these packs. They may also have additional items such as needles, catheters and syringes. The FDA warns that the convenience packs should not be used because their safety and sterility cannot be guaranteed.
According to the FDA, the company has not conducted adequate testing to confirm that their products are sterile and that endotoxin and ethylene oxide levels are within safe limits. Endotoxins are toxins that are released by bacteria when they are destroyed and EO is a toxin that remains following sterilization. Additionally, Customed failed to show that the package can ensure various stresses during transport. The FDA also said the company did not verify that the products will be effective up to their expiration dates. "These deficiencies pose a risk of serious adverse health consequences, such as infection and death." the FDA said.
The FDA issued the advisory following a string of issues starting in June 2014, when the company voluntarily recalled surgical convenience packs due to concerns over sterility. The problem was that the plastic packaging of one unit could adhere to a nearby unit during the sterilization process. The packages could subsequently tear when separated, allowing microorganisms to contaminate the items inside the packaging.
During a July 2014 inspection, the FDA found the company failed to ensure the sterilization process and packaging design were safe an effective. The findings resulted in a warning letter in December 2014. In October 2014, Customed issued another voluntary recall, adding surgical convenience trays. The FDA placed its most serious recall status, Class I, on both recalls "because the lack of assurance of product sterility, and package integrity, posed a high risk of serious adverse health consequences."
Customed stopped manufacturing its products between October and November 2014. According to the FDA, the company started manufacturing again in November 2014 without telling the FDA. The agency discovered that Customed began manufacturing again without taking proper corrective actions to address the violations. Products were also being distributed by the Puerto Rico Hospital Supply company.
The FDA inspected the company once again in April 2015 and still found testing for sterilization and packing integrity "inadequate and incomplete." Customed still failed to show that their products had acceptable low levels of endotoxin and EO. Customed issued yet another recall in July 2015 for products distributed between November 21, 2014 and June 23, 2015. "Due to persistent concerns with products still in distribution, the FDA recommends customers not use these products." the FDA states.