BBB National Programs Archive

NAD Examines Advertising Claims for Drug Delivery Systems Designed to Protect Health Care Workers; Separate Challenges Filed by BD, ICU

New York, NY – Oct. 16, 2013 – The National Advertising Division, in separate challenges brought by ICU Medical Inc. (ICU), and Becton, Dickinson & Company (BD), examined advertising for devices that are designed to help protect healthcare workers from the risks posed by working with hazardous drugs, including drugs used for chemotherapy.

NAD is an investigative unit of the advertising industry’s system of self-regulation. It is administered by the Council of Better Business Bureaus.

NAD noted in its decisions that the terms “closed system” and “closed system transfer device” are given separate definitions by the National Institute for Occupational Safety and Health (NIOSH).

A September 2004 NIOSH Alert entitled “Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings” was meant to increase awareness among health care workers and their employers about the health risks posed by working with hazardous drugs and provide measures for protecting their health.

NAD recognized that the distinction between a “Closed System” and a “CSTD” is meaningful as NIOSH has provided separate definitions for each term and has referred to both closed systems and closed-system drug-transfer devices in issuing recommendations for reducing worker exposure to hazardous drugs.

ICU argued that a published study – the Vapor Study – used by BD in its advertising for the advertiser’s oncology drug transfer device was misleading. The Vapor Study compared the performance of several different drug transfer devices and depicted the advertiser’s product, the PhaSeal, as providing superior protection.

According to ICU, the Vapor Study falsely purported to be an “apples-to-apples” comparison between medical devices that are marketed as CSTDs.

Following its review of the evidence in the record, NAD determined that the Vapor Study, as used in BD’s challenged advertising, conveyed an inaccurate superior product performance message. NAD recommended that the company discontinue such claims, as well as the use of the Vapor Study in its advertising.

NAD further determined that the advertiser provided a reasonable basis for its claim that its PhaSeal device is a “Closed System Transfer Device.”

BD, in its advertiser’s statement, said the company will, in future advertising, “give due consideration to NAD’s recommendations and strive, when using studies in support of such advertising, only to use such studies that it believes remain relevant and timely in light of the drug delivery products being marketed by BD and others.”

Separately, BD challenged the truth and accuracy of claims made by ICU for its ChemoClave system of drug transfer devices. BD contended that ICU’s advertising was likely to mislead customers, because the various ICU devices are not part of a “closed system transfer device” unless those devices are used in conjunction with a separate device called the “Genie.”

BD asserted that ICU advertised various non-Genie drug transfer devices in a manner that implies that they are an alternative “component” part of “closed” systems, suggesting that these devices, independently, constitute a “closed system transfer device when they are not CSTDs as the term is defined by NIOSH.

ICU represented that it had – during the course of the challenge – modified its advertising to eliminate any potential confusion between its ChemoClave Closed System Transfer Devices (CSTD) and ChemoClave Needlefree Closed Systems.

NAD in its decision found the modification to be necessary and appropriate to avoid the potentially confusing message that the ChemoClave System can be a CSTD absent the Genie vial access device.

NAD further noted that the website for ChemoClave CSTD identifies ChemoClave as “the world’s only needlefree closed system transfer device for the safe handling of hazardous drugs.”

While the claim is literally truthful, NAD noted, the webpage made no mention of the fact that the ICU’s Genie vial access device is required to render the system a CSTD. To avoid the potential for any confusion, NAD recommended ICU further modify the webpage to clearly and expressly disclose that a CSTD requires the Genie device.

ICU, in its advertiser’s statement, said the company “accepts NAD’s recommendation to make necessary modifications to avoid implying that ChemoCLAVE components that are not CSTDs are CSTDs. ICU will continue to use diligence when describing its products to clarify the difference between Closed Systems and CSTDs, including by citing appropriate studies and FDA clearances.”