Work Item
ASTM WK89630

Reinstatement of D4774-11(2017) Standard Specification for User Applied Drug Labels in Anesthesiology (Withdrawn 2022)


Rationale: The D4774 standard for which I am seeking reinstatement regards user-applied labels (to syringes, typically) for use in anesthesiology. The anesthesiology profession (to which I belong) considers this to be an extremely important standard, since it concerns the use of color-coding for the labels. We have relied upon the color-coding specified in D4774 since it was published over 30 years ago to help identify drugs. If D4774 remains withdrawn, we are concerned that there would be a significant deleterious impact on medication safety, as well as patient safety. The standard plays a vital role in the reduction of medication errors, through the use of color-coding as a secondary, redundant channel of information when selecting a syringe to inject a medication. The reinstatement of this standard has the support of the American Society of Anesthesiologists (ASA), the Anesthesia Patient Safety Foundation (APSF), whom I represent on this committee, and the Institute for Safe Medication Practices (ISMP). If the standard remains withdrawn, it is likely that the standardized colors used for labeling would gradually disappear from use, with the probable result that different colors would then be used to represent the same drug class, thus leading to confusion and an increase in medication errors, and a concomitant increase in adverse drug events and harm to patients, including deaths.


Developed by Subcommittee: F02.50

Committee: F02

Staff Manager: W Scott Orthey

Work Item Status

Date Initiated: 02-13-2024

Technical Contact: Richard Botney