title: Residual ethylene oxide in medical devices and device material.
abstract: Ethylene oxide (EO) gas is commonly used to sterilize medical devices. The amount of residual EO remaining in a device depends partly on the type and size of polymeric material. A major concern is the amount of residue that may be available in the body. With the use of the method described by AAMI for headspace analysis of EO residues, different polymers and medical devices subjected to different numbers of sterilization cycles were examined. Next, the effect of various extraction conditions and extraction solutions on these polymers and medical devices was evaluated. The results showed different polymers desorb EO differently. One polyurethane (PU 75D) had much higher EO residue than a different polyurethane (PU 80A). Repeated extraction of the PU 75D was necessary to quantify total EO residue levels. Different extraction solutions influence the amount and reproducibility of EO detected, whereas multiple resterilizations showed no difference in amount of residual EO. Bioavailability of EO was estimated by extracting the devices and polymers in water. Comparison of total EO residues to EO that was bioavailable showed no difference for some polymers and devices, while others had an almost eightfold difference. Some standard biocompatibility tests were run on extracts and devices, but no significant effects were observed.
authors.affiliation: Center for Devices and Radiological Health, Office of Science and Technology, U.S. Food and Drug Administration, Rockville, MD 20852, USA. adl@cdrh.fda.gov
authors.forename: Anne D
authors.initials: AD
authors.lastname: Lucas
authors.forename: Katharine
authors.initials: K
authors.lastname: Merritt
authors.forename: Victoria M
authors.initials: VM
authors.lastname: Hitchins
authors.forename: Terry O
authors.initials: TO
authors.lastname: Woods
authors.forename: Scott G
authors.initials: SG
authors.lastname: McNamee
authors.forename: Dan B
authors.initials: DB
authors.lastname: Lyle
authors.forename: Stanley A
authors.initials: SA
authors.lastname: Brown
mesh_terms: D001672:Biocompatible Materials; D001682:Biological Availability; D004202:Disinfectants / Q000032:analysis*; D004866:Equipment Contamination; D017743:Equipment Reuse; D004864:Equipment and Supplies; D005027:Ethylene Oxide / Q000032:analysis* / Q000633:toxicity; D006801:Humans; D008422:Materials Testing; D011108:Polymers / Q000737:chemistry*; D011140:Polyurethanes / Q000737:chemistry*; D013242:Sterilization / Q000379:methods
chemical_list: D001672:Biocompatible Materials; D004202:Disinfectants; D011108:Polymers; D011140:Polyurethanes; D005027:Ethylene Oxide