Effects of different disinfection and sterilization methods on tensile strength of materials used for single-use devices.
Driven by economic and time constraints, some medical centers and third parties are resterilizing single-use devices (SUDs) for reuse. The steam autoclave is quick, but most plastics used in SUDs cannot survive the temperature. Thus, a number of new methods of cleaning, disinfecting, and sterilizing these complex devices are being introduced on the market. The present study investigated the effects of a range of methods on the tensile strength of latex rubber, silicone elastomer, 2 different formulations of polyurethane, nylon, and high-density polyethylene (HDPE) specimens. The methods used were sodium hypochlorite bleach (Clorox), peracetic acid + hydrogen peroxide (Steris), formaldehyde gas (Chemiclave), low-temperature peracetic acid and gas plasma (Plazlyte), and low-temperature hydrogen peroxide gas plasma (Sterrad). The results showed that silicone elastomer was minimally affected, whereas the strengths of nylon, polyethylene, and latex were reduced by some of the methods. Depending on the formulation, the strength of polyurethane either increased or decreased. The data demonstrated that disinfection and sterilization can affect the tensile strength of certain materials used in medical devices.
Brown
Stanley A
SA
Division of Mechanics and Materials Science, U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Technology, 9200 Corporate Blvd, HFZ-150, Rockville, Md. 20850, USA.
Merritt
Katharine
K
Woods
Terry O
TO
McNamee
Scott G
SG
Hitchins
Victoria M
VM
D004203:Disinfection / Q000379:methods* / Q000639:trends; D004209:Disposable Equipment; D020724:Elastomers / Q000737:chemistry; D019544:Equipment Failure Analysis; D005740:Gases / Q000737:chemistry; D006801:Humans; D008422:Materials Testing / Q000379:methods*; D010969:Plastics / Q000737:chemistry*; D012973:Sodium Hypochlorite / Q000737:chemistry; D013242:Sterilization / Q000379:methods* / Q000639:trends; D013718:Tensile Strength; D013997:Time Factors
D020724:Elastomers; D005740:Gases; D010969:Plastics; D012973:Sodium Hypochlorite