On January 5, 2016, the Food and Drug Administration (FDA) issued a safety alert warning that Customed surgical convenience packs and trays containing items used during general hospital, dental, and obstetrical and gynecological procedures are not safe to use.
The FDA is warning staff at health care facilities not to use Customed convenience packs and trays for any surgical procedures. The integrity, safety and efficacy of these products cannot be assured because adequate testing has not been completed to assure:
- The sterility of the products,
- That endotoxin and ethylene oxide levels are within safe limits,
- That package integrity can withstand stresses during transport, and
- That the products will be effective up to their expiration dates.
These deficiencies pose a risk of serious adverse health consequences, including infection and death.
Surgical convenience packs include items such as exam gloves, absorbent towels, suture bags, surgical table covers and drapes. Surgical trays include additional items such as sodium chloride irrigation bottles, catheters, needles and syringes.
Medical devices and supplies used in surgery must be kept sterile to prevent patient infections, the FDA explains. Customed initiated a voluntary recall of its surgical convenience packs in June 2014 due to potentially compromised sterility caused by the plastic packaging of one unit sticking to adjacent units during the sterilization process. When the packs are separated, the packaging could tear, allowing microorganisms to enter and contaminate the contents.
An FDA inspection of Customed’s manufacturing facilities in July 2014 disclosed deficiencies in the sterilization process and packaging design. The FDA sent the firm a warning letter on December 9, 2014, confirming the deficiencies found during the inspection.
Customed initiated a second recall on October 8, 2014, expanding the previous recall and added surgical convenience trays. The FDA classified both recalls as Class I—the most serious recall category—because the lack of assurance of product sterility and package integrity posed a high risk of serious adverse health consequences.
The firm stopped distributing the convenience packs from October 8, 2014 to November 21, 2014, but resumed manufacturing in November 2014 without informing the FDA. In early 2015, the FDA became aware that Customed had resumed manufacturing without making the necessary corrections required by the agency. In a follow-up inspection in April 2015, the FDA determined the status of the corrective actions performed. This inspection found that the corrective actions specific to ethylene oxide (EO) sterilization validation and package integrity testing were still inadequate and incomplete.
In July 2015, Customed issued additional recalls for products distributed between November 21, 2014 and June 23, 2015, due to continued issues with validation of the sterility and packaging of contents in the convenience packs and trays. In addition, Customed could not verify the integrity of products after transport or until the listed expiration date.
Due to persistent concerns with products still in distribution, the FDA now recommends customers not use these products for any surgical procedures until their safety has been verified.