What’s the holdup?

What—or who—is standing in the way of needle safety?

The Needlestick Safety and Prevention Act (NSPA) was signed into law by President Bill Clinton in November 2000, becoming Public Law 106-430. Previously the number of needlestick injuries (NSIs) suffered annually in the United States was approximately 500,000, with about half of them occurring in hospitals. More recent data suggests that the number remains at about 380,000 per year. Although the federal law enacted 15 years ago was intended to establish a framework for significantly reducing NSIs, that hasn't happened. Why not?

More than 1.8 billion of the syringes sold annually in the United States are conventional syringes—syringes that have no safety-engineered features whatsoever!¹ More than half of the sharps-related (predominantly needlestick) injuries in 2012 occurred when devices were being used that had no injury-prevention feature.² The vast majority of the remaining needlestick accidents resulted from widespread use of ineffective manually-operated devices provided by the two largest manufacturers.

Contaminated needlestick injuries to clinicians and others can transmit bloodborne diseases to the victims—lethal and life-changing diseases such as HIV, hepatitis B, hepatitis C, and many others. The safety and lives of healthcare workers and others continue to be needlessly placed at risk. Why do we put up with it? The risks of infection to needlestick victims and the associated treatment cost to employers and insurers dictate that more be done.

Affordable technology capable of reducing the number of NSIs to virtually zero has been readily available to hospitals and clinicians throughout the past 15 years. So why is it not being used? What is the holdup? Who is profiting by delaying access to effective safety devices and continuing the status quo?

More than 70 percent of the U.S. syringe and needle market is dominated by a single company, Becton Dickinson and Company (BD).³ That company and one other company supply more than 85 percent of the U.S. market.⁴ How have those companies responded to the NSPA? Rather than introducing innovative syringes and blood collection devices that could have curtailed NSIs, BD continued selling unprotected, unsafe syringes as its principal product. For customers insisting on a "safe" product, BD adapted its existing products with pivoting shields or sliding tubes that can be manipulated to cover the needle tip following an injection. Unfortunately, the sale and use of such "safety" devices has been shown to increase—not reduce—the relative number of NSIs as compared to conventional, unprotected syringes while continuing to generate large profits for the industry leaders. So why have other companies with demonstrably safer syringe technology not stepped forward to command a larger segment of the syringe market?

Facts reported from widespread litigation during the past 10 years (alleging violations of the antitrust, unfair competition and deceptive advertising laws by GPOs and/or medical product suppliers) suggest that smaller companies attempting to sell their safety products to acute care facilities including the approximately 6,000 hospitals in the U.S. have been repeatedly and effectively blocked or repulsed by defensive marketing tactics utilized by the market leaders in cooperation with group purchasing organizations (GPOs). Almost all U.S. hospitals purchase medical supplies including their syringes, blood collection tube holders, and other venipuncture devices from GPOs. The GPOs are what the New York Times, in a series of articles several years ago, called "Medicine's Middlemen."⁵ The GPOs have been granted a "safe harbor" by the federal government, allowing them to legally accept kickbacks from the big manufacturers, something that would be illegal in other industries.⁶ Ostensibly the GPOs use their purchasing clout to save the hospitals money on supplies. In theory, that would seem to make sense. However, some knowledgeable observers have questioned whether that really is the case in many instances. Those observers include the United States General Accounting Office, the International Center for Corporate Accountability, and the New York Times, among others.⁷

GPOs typically contract with hospitals and with manufacturers and marketers of medical supplies. Such contracts may, for example, require hospitals to buy 90 or 95 percent of their supplies through the GPO. The contracts also often "bundle" dissimilar products together as a condition of receiving discounts—often with products that are only available from one or two large medical products companies. Such contracts can have the effect of locking out small, innovative medical suppliers who may have a narrower range of available products. Since GPOs receive a percentage of the proceeds of their sales to hospitals, they have little or no incentive to question the marketing programs of their suppliers or to scrutinize the profits generated by the prices being charged to the hospitals. In effect, the GPOs become "partners" with the major suppliers in a scenario that perpetuates the use of products less safe (and more expensive) than would otherwise be available to the healthcare workers using those products, and the money rolls in.

So why is it that in the U.S., a country generally viewed as a champion of free enterprise and open competition, hospitals are not permitted to pick and choose from available technologies, and purchase those products that offer greater safety for their own employees? How can medical product suppliers continue to give lip service to marketing safe products in the face of evidence to the contrary? Here we are, a decade and a half after the NSPA became the law of the land, and we still have almost 400,000 NSIs per year.

Fortune 500 medical products companies have a variety of tools at their disposal to perpetuate the "protect the profits" business model currently practiced in the hospital purchasing environment, particularly in relation to smaller, developing companies that often possess more innovative and safer solutions to existing problems such as NSIs. The tools used by the "big dogs" include contracts, rebates, advertising, lobbying, acquisitions, and protracted, cost-prohibitive litigation. What will it take to provide tools that allow small manufacturers to compete and provide greater safety to healthcare workers? More NSIs, infections and deaths? More entrepreneurial companies with great products collapsing from the inability to even talk to prospective purchasers about their innovations? When will enough be enough? What's the holdup? It is time for more hospital systems to demand safe products for their workers and for those workers (and their union representatives) to demand the availability of the latest innovations to protect those workers' lives.

1. U.S. Market for Vascular Access Devices and Accessories, iData Research Inc., Report iDATA_USVA14_RPT, Vancouver, British Columbia, Canada, 2014, p. 292.
2. Syringes (Disposable and Reusable), Global Industry Analysts, Inc., Report MCP-3229, June 2014, p. III-2.
3. U.S. Market for Vascular Access Devices and Accessories, iData Research Inc., Report iDATA_USVA14_RPT, Vancouver, British Columbia, Canada, 2014, p. 316.
4. Ibid.
5. A series of 15 articles published in the New York Times under the series heading "Medicine's Middlemen" in 2002. Each article was written by Walt Bogdanich, Mary Williams Walsh, and/or Barry Meier.
6. Michael E. Porter and Elizabeth Olmsted Teisberg, Redefining Health Care, Boston, 2006, pp. 361-362.
7. GROUP PURCHASING ORGANIZATIONS: Pilot Study Suggests Large Buying Groups Do Not Always Offer Hospitals Lower Prices, United States General Accounting Office, Report No. GAO-02-690T, April 20, 2002; Prakash Sethi, Group Purchasing Organizations: An Evaluation of Their Effectiveness in Providing Services to Hospitals and their Patients, International Center for Corporate Accountability, Report No. ICCA-2006.G-01, 2006; and New York Times, "Medicine's Middlemen" series (as cited in endnote number 5, above).

Robert J. Duncan is a Writer/Editor for Retractable Technologies, Inc.

The views, opinions and positions expressed within these guest posts are those of the author alone and do not represent those of Becker's Hospital Review/Becker's Healthcare. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them.​