Tag Archives: adverse events

Identical tubing demonstrates FDA’s inaction

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

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.

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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.

euPhoto by bennylin0724 via Flickr

Since 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.”

Report looks at disclosure of adverse events

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

Adverse events that harm patients are publicly reported unevenly, according to a report from the inspector general for the Department of Health and Human Services.

The report reviewed the public disclosure of the information by state adverse reporting systems, patient safety organizations and the Centers for Medicare & Medicaid Services. As the report points out, reporting such events can help educate health care providers about why such events happen and how to prevent them.

The report (Adverse Events in Hospitals: Public Disclosure of Information about Events OEI-06-09-00360) does highlight seven state systems that are disclosing more information than others: Maryland, Massachusetts (both the Board of Registration in Medicine and the Department of Public Health), Minnesota, New Jersey, Oregon and Pennsylvania.

The inspector general points to those systems as models:

The disclosure practices of the seven State systems with more extensive disclosure can serve as models for other entities. These systems disclose analysis of the causes of events, evidence-based guidance for reducing occurrences, and information about demonstrated improvements by hospitals. This type of information, if disseminated by other State systems and entities that receive adverse event information, could help to improve patient safety.

The report provides some useful information for journalists about what information is publicly reported and AHCJ is, of course, gratified to see a government report that advocates public disclosure of patient safety information.

Cheryl Clark of HealthLeaders Media wrote about the report.