title: A designed experiment for evaluation of the OPA method for cleaning studies of medical devices.
abstract: This study reports the results of a designed experiment to evaluate the use of the o-phthalic dialdehyde (OPA) method for residual protein, with a testsoilderivedfrom blood, dehydrated hog mucin, and egg yolk, and its application in validating the automated cleaning of surgical instruments in a laboratory setting. The ruggedness and robustness of the OPA method was determined by means of a Plackett-Burman experimental design and assessed the automated cleaning of a microkeratome for use in patients undergoing lamellar resection of the cornea during refractive surgery. The outcome of the study indicates that the OPA method for residual protein is rugged and robust for the factors evaluated and is an effective means for validating the cleaning of complex medical devices under controlled laboratory conditions. The components of the microkeratome contaminated with the test soil were successfully cleaned in an automated washer-disinfector using a neutral pH detergent and the procedure as described.
authors.affiliation: Bausch & Lomb, Inc., USA. pmccormick@bausch.com
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: McCormick
authors.forename: James J
authors.initials: JJ
authors.lastname: Kaiser
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Schoene
authors.forename: Deborah L
authors.initials: DL
authors.lastname: Shlatz
authors.forename: Susan E
authors.initials: SE
authors.lastname: Norton
mesh_terms: D001774:Blood Chemical Analysis / Q000379:methods*; D001798:Blood Proteins / Q000032:analysis* / Q000737:chemistry; D004866:Equipment Contamination / Q000517:prevention & control*; D019544:Equipment Failure Analysis / Q000379:methods*; D017743:Equipment Reuse; D004864:Equipment and Supplies; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013242:Sterilization / Q000379:methods*
chemical_list: D001798:Blood Proteins