NAD Recommends CareFusion Modify, Discontinue Certain Ad Claims for Needleless IV Connectors

The UL CAP provides transparency to product and system cybersecurity by bringing industry initiatives, regulations, standards and best practices together into one reliable testing and certification program.

New York, New York – March 15, 2011 – The National Advertising Division of the Council of Better Business Bureaus has recommended that CareFusion Corporation modify or discontinue certain advertising claims for “needleless” IV connectors used in the administration of intravenous drugs.

NAD, the advertising industry’s self-regulatory forum, reviewed claims made by CareFusion in Internet advertising and in promotional materials following a challenge by ICU Medical, Inc., a competing manufacturer of needleless IV connectors.

Both parties make needleless connectors that are used to join a syringe to a catheter for the administration of intravenous medications in a hospital setting. According to a 2006 report by the Centers for Disease Control, catheter-related blood stream infections (CRBSIs) are estimated to occur 250,000 times each year in hospitals in the United States, resulting in deaths and increased healthcare costs.

Additionally, infection control experts have studied whether some types of needleless connectors have contributed to the development of bloodstream infections.
NAD reviewed claims that included:

• The MaxPlus connector is “proven to reduce BSIs” (bloodstream infections);
• The MaxPlus connector “helps prevent bloodstream infections”;
• Provides the “maximum barrier to microbial ingress”;
• The MaxPlus connector “is proven to reduce occlusions”;
• The MaxPlus connector “helps reduce occlusions”;

NAD also reviewed CareFusion’s “Glo Germ” glow-in-the-dark gel demonstration, which
showed a bacteria-free MaxPlus connector and a highly contaminated connector from ICU.
(Full text of decision available to media upon request.)

NAD noted in its decision that the nature and extent of claims made by an advertiser should mirror the precision and specificity of the data upon which the advertiser relies to substantiate its claim.
In this case, NAD noted, the advertiser made very broad superior performance claims that compared the ability of the MaxPlus product to reduce BSIs to all competing needleless connectors. However, NAD noted, none of the studies offered as substantiation compared MaxPlus to a significant portion of the needleless connector market, let alone all competing connectors.

Following its review of the evidence in the record, NAD recommended the advertiser avoid comparisons to competing connectors and modify claims that its MaxPlus connector is
“proven to reduce BSIs” and that it “helps prevent bloodstream infections,” to make clear that reductions in infections occurred in combination with a hospital’s implementation of improved clinical practices.

NAD recommended that advertiser discontinue promotional materials that offered a “quick review” of the studies relied upon by the advertiser, which referenced the connectors tested in those studies and the whether BSIs increased or decreased.

NAD noted that the promotional piece failed to provide a full and accurate summary of the studies, including any pertinent limitations as to the differences in institutions and clinical practices.
NAD further recommended that the unsupported claims that the MaxPlus connector “is proven to reduce occlusions” be discontinued and that the claim MaxPlus connector “helps reduce occlusions” be modified to indicate that the reduction occurred in conjunction with improvements in clinical practices.

NAD recommended that the advertiser modify the Glo Germ demonstration and instructions on using Glo Germ be modified to clearly and conspicuously disclose, in close proximity to the demonstration, that the demonstration does not represent the performance of the advertiser’s or competing products under actual use conditions.

NAD recommended that the demonstration be limited to show that some bacteria can be left behind even when proper disinfection practices are in place.

NAD recommended that the claim the “maximum barrier to microbial ingress” be modified to more closely reflect the conclusions of the studies upon which it is based and that it be qualified to make clear the basis of comparison.

Finally, NAD recommended that the advertiser avoid conveying the unsupported message that its product has superior “cleanability” and infection control properties as compared to ICU’s connectors. NAD noted, however, that the advertiser is free to support the design of the MaxPlus Clear connector, which allows nurses see blood that should be flushed.

The company, in its advertiser’s statement, said it would modify or discontinue all claims at issue in accordance with NAD’s decision.

###

NAD's inquiry was conducted under NAD/CARU/NARB Procedures for the Voluntary Self- Regulation of National Advertising. Details of the initial inquiry, NAD's decision, and the advertiser's response will be included in the next NAD/CARU Case Report.

About Advertising Industry Self-Regulation: The National Advertising Review Council (NARC) was formed in 1971. NARC establishes the policies and procedures for the National Advertising Division (NAD) of the Council of Better Business Bureaus, the CBBB’s Children’s Advertising Review Unit (CARU), the National Advertising Review Board (NARB) and the Electronic Retailing Self-Regulation Program (ERSP).

The NARC Board of Directors is composed of representatives of the American Advertising Federation, Inc. (AAF), American Association of Advertising Agencies, Inc., (AAAA), the Association of National Advertisers, Inc. (ANA), Council of Better Business Bureaus, Inc. (CBBB), Direct Marketing Association (DMA), Electronic Retailing Association (ERA) and Interactive Advertising Bureau (IAB). Its purpose is to foster truth and accuracy in national advertising through voluntary self-regulation.
NAD, CARU and ERSP are the investigative arms of the advertising industry’s voluntary self-regulation program. Their casework results from competitive challenges from other advertisers, and also from self-monitoring traditional and new media. NARB, the appeals body, is a peer group from which ad-hoc panels are selected to adjudicate NAD/CARU cases that are not resolved at the NAD/CARU level. This unique, self-regulatory system is funded entirely by the business community; CARU is financed by the children’s advertising industry, while NAD/NARC/NARB’s primary source of funding is derived from membership fees paid to the CBBB. ERSP’s funding is derived from membership in the Electronic Retailing Association. For more information about advertising industry self-regulation, please visit www.narcpartners.org.

Media Contacts

ICU Medical

Tom McCall, Corporate Vice President and General Manager  
(949) 366-4368
tmccall@icumed.com

℞ Only. For safe and proper use, refer to the instructions for use.