Reading the small print - labelling recommendations for orthopaedic implants.
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.
Haene
Roger A
RA
Department of Orthopaedic and Trauma Surgery, Ipswich Hospital, Heath Road, Ipswich IP4 5PD, UK. roger@haene.org
Sandhu
Ranbir S
RS
Baxandall
Richard
R
D004780:Environment, Controlled; D006801:Humans; D019637:Orthopedic Procedures; D011356:Product Labeling / Q000592:standards*; D019736:Prostheses and Implants; D011932:Reading
J Bone Joint Surg Am. 1982 Apr;64(4):525-35
7068695
J Cataract Refract Surg. 2003 Aug;29(8):1487-95
12954294
Clin Orthop Relat Res. 1977 Jan-Feb;(122):231-43
837613
Br Med J (Clin Res Ed). 1982 Jul 3;285(6334):10-4
6805791
J Hosp Infect. 1988 May;11 Suppl C:18-40
2899118
Cornea. 2001 Jul;20(5):471-4
11413400
J Hosp Infect. 1996 Jan;32(1):1-7
8904367
Perception. 2004;33(7):869-89
15460513
Br J Ophthalmol. 1955 Sep;39(9):513-33
13250140
Ergonomics. 2006 Apr 15-May 15;49(5-6):617-30
16717013
Br J Surg. 1969 Sep;56(9):641-9
5808372
Optom Vis Sci. 2001 Jan;78(1):50-5
11233335