The effect of repeated ethylene oxide sterilization on the mechanical strength of synthetic absorbable sutures.
The purpose of this study was to determine the effect of repeated ethylene oxide sterilization using a standard clinical protocol on sutures, a type of medical device labeled for single use and reported to be reprocessed for use after being opened but not used. Four types of commonly used synthetic absorbable sutures were subjected to 1 and 2 ethylene oxide resterilization cycles. Knot tensile strength was determined for new sutures and for sutures that had been subjected to 1 and 2 ethylene oxide resterilization cycles. As has been found with other types of single-use devices, no general conclusions can be made for absorbable sutures. The strengths of different types of sutures increased, decreased, or stayed the same after repeated sterilization. In addition, the inner packages of some sutures were not intact after reprocessing, possibly exposing the sutures to increased humidity, which can produce degradation leading to loss of strength both immediately and after additional shelf aging and degraded performance after clinical use.
Woods
T O
TO
Division of Mechanics & Materials Science, HFZ-150, US Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Technology, 9200 Corporate Blvd, Rockville, MD 20850, USA.
Brown
S A
SA
Merritt
K
K
McNamee
S G
SG
Hitchins
V M
VM
D005027:Ethylene Oxide / Q000494:pharmacology*; D013242:Sterilization / Q000379:methods*; D013537:Sutures; D013718:Tensile Strength
D005027:Ethylene Oxide