Patient Skin Preparation Product Labels Updated Based on FDA Recommendations
The U.S. Food and Drug Administration (FDA) has requested that companies voluntarily make updates to their skin antiseptic products. This request was the result of infrequent reports of infections caused by contaminated skin preparation products.
In response to this industry-wide request initiated by the FDA, BD updated the labels on its ChloraPrep™ patient preoperative skin preparation portfolio in March 2015. We are now updating the remainder of the skin preparation product portfolio labels with information intended to ensure continued clinician education and patient safety.
BD is in the process of updating its product labels by:
- Adding the phrase "non-sterile solution" on the label of all products indicated for preoperative skin prep
- Including the phrase "single-use" for all products indicated for preoperative skin preps
- Removing the phrase "patient preoperative skin preparation" or "preinjection skin preparation" on multiple-use containers
The same antisepsis solution
Our skin preparation products have not changed in any way and continue to be a broad portfolio of antiseptic solutions. For a full list of the affected products, see the enclosed file and its chart of products and their associated updates.
Questions?
For more information, contact your sales representative or Customer Support at +65 6664 2700
The AORN Seal of Recognition was awarded to the CareFusion CHP label change program on February 20, 2015, and does not imply that AORN approves or endorses any product or service mentioned in any presentation, format or content. The AORN Recognition program is separate from the AORN, ANCC Accredited Provider Unit and therefore does not include any CE credit for programs.
