title: Damage of office supply, personal use items, and over-the-counter medical devices after sterilization by ethylene oxide gas, electron beam, and gamma radiation.
abstract: After letters containing Bacillus anthracis spores entered the U.S. mail in 2001, a problem emerged regarding how to decontaminate the letters, packages, and personal items in offices that received these letters. The effects of three sterilization methods (i.e. ethylene oxide gas [EO], electron beam [e-beam] radiation, and gamma radiation) were evaluated for a variety of office supply and equipment, personal use items, and over-the-counter medical devices. No single sterilization method was suitable for all items that could be mailed or found in an office. Damage or discoloration was evident for some items by each sterilization method. There were changes in the color of certain items, such as some of the packaging material, some pacifiers, some of the fabrics, and the nylon stockings after e-beam and gamma radiation. Both e-beam and gamma radiation damaged all film samples. Following EO sterilization and normal aeration, there were a number of samples with high (above 250 microg/g) levels of EO and samples with detectable ethylene chlorohydrin levels. The data would suggest that certain items exposed to EO sterilization must be further aerated prior to use, or discarded. Generic descriptions of products (such as plastics) or grouping of items (such as condoms) were not sufficient to predict what is safe in terms of EO residual levels remaining on an item. Successful decontamination of a wide variety of items will require careful selection of different sterilization methods.
authors.affiliation: U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Silver Spring, MD, 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
mesh_terms: D015374:Biosensing Techniques; D004583:Electrons; D004864:Equipment and Supplies; D005027:Ethylene Oxide; D005720:Gamma Rays; D009817:Office Management; D011177:Postal Service; D013242:Sterilization; D014481:United States
chemical_list: D005027:Ethylene Oxide