Orthopaedic Implant Labeling – how small is too small? Preventing a Never Event [post]

2019 unpublished
There are currently no guidelines for the standards of legibility, dimensions and presentation on implant labels. There have been recommendations that text height on implant boxes should be at least 4mm. Orthopaedic implants are packaged individually and checked intraoperatively once the correct size has been identified. During this process there are many factors that could lead to error. Dimensions of laminar flow canopies fixes the distance at which the implant label can be read from. Never
more » ... read from. Never events are multifactorial. Small text, poor vision due to liquid on a surgeons visor and the seam of the plastic packaging can obscure vital information and contribute to a never event. Methods We reviewed elective and trauma implants. Using the National Joint Registry 15th Annual Report we identified the most commonly used total hip and knee arthroplasty implants (4 hip and 3 knee). We also reviewed the femoral nail and plate implants of 3 commonly used implant companies. Implant box text size was compared to a theoretical minimum standard of 4mm for text on implant labels derived from Snellen Chart Formula. Results 20 implants were reviewed (hip -8, knee 6, trauma-6). Across all implants, the average implant size text height was 2.8mm. The average for trauma and elective implants was the same. The average expiry date is 2mm in height. On 65% (13/20) of implant boxes, the plastic wrapping seam obscured vital text. 15% (3/20) of boxes had a text height of 4mm. Conclusion The recommended text height is 4mm. This was observed in only 15% of implants. Never events are usually multifactorial however, occur in part due to poor legibility of implant labels leading to incorrect implants being inserted. To further progress these recommendations, manufacturers can consider and adopt these suggestions to reduce risk and improve patients' safety when their implants are being used.
doi:10.21203/rs.2.16347/v1 fatcat:dorgd6x6tzczdn3jk3p7fhfsqi