FDA received an industrial complaint alleging that the packaging design for one type of absorbable suture did not maintain the integrity of seals in the packaging throughout the life of the product. This study was designed to determine whether the alleged health threat of epidemic wound dehiscence was genuine, and to develop a test method which could be used as part of a performance-based standard for the integrity of foil-type device packaging. An accelerated aging protocol designed to determine the effects of heat and humidity on packaged sutures and an in vitro test of retained strength after implantation for absorbable sutures were also examined. The experimental design responded to concerns expressed by the Offices of Compliance and Device Evaluation.
Sutures of various ages were retrieved and tested out of package and after in vivo exposure. New sutures were randomized into four treatment groups for accelerated aging and placed into environmental chambers. Knot tensile strength was determined for sutures tested out of package and after 1, 2, and 3 week in vivo and in vitro exposure for 5 periods of aging. Results of the testing will be presented.