title: Extraction and stability of ethylene oxide residue in medical devices.
abstract: Ethylene oxide (EO) gas is commonly used to sterilize medical devices. A major concern is the amount of residue that may remain on or in the device and be available in the body. Some standards (ASTMF619 and ISO 10993-12) recommend using two different extraction solutions (one polar, one nonpolar), for sample preparation prior to testing medical devices. However, ISO 10993-7 recommends water to process medical devices to determine EO residual levels. To address this, EO residual levels were examined in different extraction solutions. EO residual levels from devices and materials extracted with different solutions were evaluated. Results from this study indicate little difference between extraction solutions of water, cell culture media, and serum (less than 30% difference). Given the increased cost and increased background noise of media or serum over water, using only water to process medical devices and materials for EO residues appears adequate.
authors.affiliation: Center for Device and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20903, USA. anne.lucas@fda.hhs.gov
authors.forename: Anne D
authors.initials: AD
authors.lastname: Lucas
authors.forename: Melvin E
authors.initials: ME
authors.lastname: Stratmeyer
mesh_terms: D004864:Equipment and Supplies; D005027:Ethylene Oxide / Q000302:isolation & purification*; D013242:Sterilization; D014481:United States
chemical_list: D005027:Ethylene Oxide