Identical tubing demonstrates FDA’s inaction
In The New York Times, Gardiner Harris outlines the problem of medical tubing that looks very similar – leading to medical errors – then deftly works his way up the chain in an attempt to find the source of device regulator’s failure to solve a problem that seems entirely solvable.
Many medical device tubing looks the same, which leads to horrific mix-ups like the delivery of food straight into the bloodstream. In 2007, The Wisconsin State Journal’s David Wahlberg earned first place in the medium newspapers category of AHCJ’s Awards for Excellence in Health Care Journalism for his Medical Misconnections series, which detailed the same problems. He even wrote an AHCJ article teaching journalists how to investigate patient safety problems.
Photo by bennylin0724 via FlickrSince then, not much has changed. Which is not all that surprising, when you consider that not much had changed in the decades before Wahlberg’s story either. Harris’ mission is to dig past the finger-pointing and figure out why. In the end, it all seems to point to some remarkable systemic flaws in the FDA’s device approval system, as well as an unwillingness on the industry to change without the threat of brute regulatory force. In addition to compelling analysis, Harris punctuates each argument with a few spicy quotes.
You’ll have to read Harris’ story to truly understand the perversity of the FDA system and how its lent such inertia to the status quo, but here’s a sample:
Dr. Robert Smith, an F.D.A. device reviewer who left the agency on July 31 and was among nine agency employees who in 2009 decried the agency’s device approval process as illegal and dangerous, said that the tubing problem, which has gone on for decades, was another example of how the agency failed to protect the public. “F.D.A. could fix this tubing problem tomorrow, but because the agency is so worried about making industry happy, people continue to die,” Dr. Smith said.
And, from Nancy Pratt, a senior vice president at Sharp HealthCare in San Diego who believes that “Nurses should not have to work in an environment where it is even possible to make that kind of [tubing] mistake.”
“The regulators have been waiting for the manufacturers to come up with a solution,” Ms. Pratt said, “and the manufacturers won’t spend the money to design and produce something different until the regulators force them to. And now the international standards organization is taking forever to get the whole world onto the same page.”
Obama releases documents from advocacy groups
Jennifer LaFleur at ProPublica points out that “President-elect Barack Obama’s transition team seems to be following through with its promise of transparency by posting documents from its meetings with industry and advocacy groups.”
There are some health-related documents among the postings:
AIDS in America: An agenda endorsed by 15 national organizations that calls for “the development of a National AIDS Strategy for the U.S. that is designed to lower HIV incidence, increase access to HIV care, and reduce racial disparities in the epidemic and integrate HIV with STD, viral hepatitis and TB programs at the local level.”
Asian Pacific Islander American Health Forum: “Priorities for the new administration to improve the health and well-being of Asian Americans, Native Hawaiians and Pacific Islanders”
Analysis of HIV/AIDS Priority Issues for Immediate Action: List of issues for “immediate action” from the AIDS Action Council
Advancing Reproductive Rights and Health in a New Administration: Agenda from a coalition of about 60 medical, public health, research, religious and religiously affiliated, women’s health, legal, and other advocacy organizations.
National Water Policy Dialogue: The American Water Resources Association, the Environment and Water Resources Institute of the American Society of Civil Engineers and the National Wildlife Federation submitted a summary of the National Water Policy Dialogues conducted by AWRA at the request of 10 federal water agencies. Water quality is among their concerns.
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