title: The role of packaging size on contamination rates during simulated presentation to a sterile field.
abstract: OBJECTIVE
  The objective of this study was to assess the impact of package size on the contact between medical devices and non-sterile surfaces (i.e. the hands of the practitioner and the outside of the package) during aseptic presentation to a simulated sterile field. Rationale for this objective stems from the decades-long problem of hospital-acquired infections. This work approaches the problem from a unique perspective, namely packaging size.
  
  
  METHODS
  Randomized complete block design with subsampling.
  
  
  METHODS
  Research study conducted at professional conferences for surgical technologists and nursing professionals.
  
  
  METHODS
  Ninety-seven healthcare providers, primarily surgical technologists and nurses.
  
  
  METHODS
  Participants were gloved and asked to present the contents of six pouches of three different sizes to a simulated sterile field. The exterior of pouches and gloves of participants were coated with a simulated contaminant prior to each opening trial. After presentation to the simulated sterile field, the presence of the contaminant on package contents was recorded as indicative of contact with non-sterile surfaces and analyzed in a binary fashion using a generalized linear mixed model.
  
  
  RESULTS
  Recruited subjects were 26-64 years of age (81 females, 16 males), with 2.5-44 years of professional experience. Results indicated a significant main effect of pouch size on contact rate of package contents (P = 0.0108), whereby larger pouches induced greater rates of contact than smaller pouches (estimates±SEM: 14.7±2.9% vs. 6.0±1.7%, respectively).
  
  
  CONCLUSIONS
  This study utilized novel methodologies which simulate contamination in aseptic presentation. Results of this work indicate that increased contamination rates are associated with larger pouches when compared to smaller pouches. The results add to a growing body of research which investigate packaging's role in serving as a pathway for product contamination during aseptic presentation. Future work should investigate other packaging design factors (e.g. material, rigidity, and closure systems) and their role in contamination.
authors.affiliation: School of Packaging, Michigan State University, East Lansing, Michigan, United States of America.
authors.forename: Tony
authors.initials: T
authors.lastname: Trier
authors.affiliation: Department of Statistics, Kansas State University, Manhattan, Kansas, United States of America.
authors.forename: Nora
authors.initials: N
authors.lastname: Bello
authors.affiliation: Department of Mechanical Engineering, Michigan State University, East Lansing, Michigan, United States of America.
authors.forename: Tamara Reid
authors.initials: TR
authors.lastname: Bush
authors.affiliation: School of Packaging, Michigan State University, East Lansing, Michigan, United States of America.
authors.forename: Laura
authors.initials: L
authors.lastname: Bix
mesh_terms: D000328:Adult; D003428:Cross Infection / Q000517:prevention & control; D004866:Equipment Contamination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019064:Product Packaging / Q000295:instrumentation*; D011481:Protective Clothing; D011897:Random Allocation; D013242:Sterilization / Q000295:instrumentation*