title: Reading the small print - labelling recommendations for orthopaedic implants.
abstract: BACKGROUND
  There exist, currently, no clear guidelines regarding standards for surgical implant labelling. Dimensions of the laminar flow canopies in orthopaedic use fixes the distance at which implant labels can be read. Mistakes when reading the label on an implant box can pose health risks for patients, and financial consequences for medical institutions.
  
  
  METHODS
  Using scientifically validated tools such as the Snellen Chart Formula, a theoretical minimum standard for text on implant labels was reached. This theoretical standard was then tested under real operating conditions. After discovering a minimum practical standard for implant labels, the authors then audited current labels in use on a wide range of orthopaedic implant packages. Furthermore, other non-text-related labelling problems were also noted.
  
  
  RESULTS
  There is a definite minimum standard which should be observed when implant labels are manufactured. Implants in current use bear labels on the packaging that are of an insufficient standard to ensure patient safety in theatre.
  
  
  CONCLUSIONS
  The authors have established text parameters that will increase the legibility of implant labels. In the interests of improving risk management in theatre, therefore, the authors propose a standard for orthopaedic implant labelling, and believe this will provide a useful foundation for further discussion between the orthopaedic community and implant manufacturers.
authors.affiliation: Department of Orthopaedic and Trauma Surgery, Ipswich Hospital, Heath Road, Ipswich IP4 5PD, UK. roger@haene.org
authors.forename: Roger A
authors.initials: RA
authors.lastname: Haene
authors.forename: Ranbir S
authors.initials: RS
authors.lastname: Sandhu
authors.forename: Richard
authors.initials: R
authors.lastname: Baxandall
mesh_terms: D004780:Environment, Controlled; D006801:Humans; D019637:Orthopedic Procedures; D011356:Product Labeling / Q000592:standards*; D019736:Prostheses and Implants; D011932:Reading
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