The New York Times recently published a front-page investigation into the tragedy of incorrectly placed patient tubes, and the apparent prolonging of this decades-old problem due to the truculence of medical device manufacturers.
The potential for incorrectly placing a tube is high. More than 15 percent of clinicians surveyed admitted to having such an error occur in their hospital, according to a study published in the Joint Commission Journal on Quality and Patient Safety in 2006.
Tube mix-ups are a grave error, leading to a sentinel event 33 percent of the time. In the case of accidentally placing feeding tubes into the bloodstream, it leads to a sentinel event 66 percent of the time (in turn, more than two-thirds of sentinel events are fatal).
According to the Joint Commission, non-sentinel errors cost hospitals an average of $4,700 apiece. One can only imagine what a sentinel event costs a hospital given the patient resuscitation, intensive care and corrective procedures that must be provided--not to mention the withheld Medicare or Medicaid payments.
The Times article initially focused on such errors, but then emphasized the Food and Drug Administration's reluctance in making needed regulatory changes in its product approval process, primarily due to pressure from manufacturers.
"FDA could fix this tubing problem tomorrow, but because the agency is so worried about making industry happy, people continue to die," Robert Smith, a physician and former FDA reviewer, told the Times.
In actuality, hospitals have just as much putative power as the FDA to change the tube and tube connector manufacturing process.
That power lies within VHA and Premier, the two giant healthcare purchasing alliances. Combined, they serve 3,800 hospitals nationwide, acting as agents in the procurement of tens of billions of dollars of supplies and equipment each year.
VHA and Premier work on a simple principle: The more hospitals they represent, the larger the economies of scale they possess to wangle discounts from manufacturers.
So, were VHA and Premier to request all tube and tube connection manufacturers make their products less confusing to use--or face elimination from their offerings list--they would have little alternative but to comply. It would be a tough road to try and sell directly to hospitals when they refused to follow a directive from the cooperatives, particularly given VHA and Premier have been engaged in many initiatives to improve the quality of healthcare delivery.
Of course, this would likely lead to shrieks of anti-competitive practices from the manufacturers, even as they have leveraged the sour mood against the federal government to gull the FDA into treating their products with kid gloves. No doubt lawsuits would follow.
However, both cooperatives have taken substantial pains to be transparent in their governance. Most of their owners--the hospitals--are also non-profit organizations. These two facts would make such charges hard to stick.
Moreover, the recent appointment of former Institute for Healthcare Improvement CEO Donald Berwick to head the Centers for Medicare and Medicaid Services suggests the anti-government mood in the country is being matched by an equal passion for cost-consciousness and value in our healthcare delivery, as everyone will soon be mandated to purchase coverage.
If such a sentiment isn't shared by our nation's courts, perhaps the manufacturers can be reminded of the consequences of their inactions by the families of Jasmine Gant and Robin Rodgers, among those patients who have lost their lives due to tube mix-ups. Gant was 16; Rodgers, 24.
Within such a context, the manufacturers' grumblings that the FDA is an intrusive government body will likely receive as sympathetic an audience as such an argument deserves. - Ron
Editor's note: Ron Shinkman was Los Angeles bureau chief for Modern Healthcare and is publisher and editor-in-chief of Payers & Providers newsletter.