by Marshall Allen and Annie Waldman, ProPublica
This story was co-published with NPR’s Shots blog.
When medical device entrepreneur Joe Kiani announced his commitment to eliminating medical mistakes, he did it with panache. His medical device company, Masimo Corporation, funded the launch of a nonprofit called the Patient Safety Movement Foundation. And at its flashy inaugural summit in 2013 – featuring former President Bill Clinton as the keynote speaker – Kiani pledged to galvanize the medical industry to reduce the number of deaths from medical errors across the country from hundreds of thousands a year to zero.
“Of all the dreams I’ve had none seem as important as this dream: The dream of no more preventable patient death,” Kiani said to the gathering of health care leaders.
Now people will see whether Kiani, and his company, Masimo, walk the talk. Keeping patients safe requires device makers to respond appropriately to complaints. But an inspection by the Food and Drug Administration last year found Masimo didn’t adequately investigate dozens of reports that its devices may have malfunctioned.
The FDA didn’t find that Masimo’s devices were defective, but rather that the company wasn’t sufficiently looking into that possibility. The inspection report was obtained by ProPublica via public records request.
With over $500 million in annual sales, Masimo is one of the leading makers of noninvasive pulse oximeters – patient monitoring devices that track pulse and blood oxygen, often clipped gently onto fingers or toes. Doctors in emergency rooms and intensive care units rely on the monitors to alert them when a patient has abnormal readings. If the devices give inaccurate readings or fail to alert doctors to drastic changes in a patient’s vital signs, doctors could misdiagnose or fail to recognize the severity of a patient’s condition, which could lead to injury or death.
The complaints identified in the FDA inspection varied. In one case a patient suffered a burned toe, and in another there was a question about whether an alarm properly sounded before a patient died.
If a patient or health care provider sees a problem with one of Masimo’s products they can report the problem to the company, which is then required by law to investigate. If the device malfunctioned or was implicated in a patient injury or death, the company must in turn disclose that to the FDA.
After the agency’s inspection last year, Masimo disputed the FDA conclusions, saying the agency had misunderstood the circumstances surrounding each complaint. But after nearly a year of review, the FDA stuck to its findings. It reprimanded the company with an official warning letter this August, stating that Masimo was still not adequately responding to complaints about its devices.
FDA warning letters aren’t common – it’s the first Masimo has received in its 25-year history. They are generally reserved for significant violations that could result in an enforcement action, such as fines or a recall. The agency declined to offer further comment.
Diana Zuckerman, an expert on medical devices and president of the National Center for Health Research, reviewed the FDA’s findings and Masimo’s response at ProPublica’s request. She said it appears that Masimo is “not taking the care to investigate their own possible malfunctions.”
Since patients or doctors often don’t report problems with products, Zuckerman said, complaints that are filed are “always the tip of the iceberg.” Zuckerman added that she found it striking that Masimo disputed most of the complaints and “particularly troublesome” that the company challenged a complaint that involved questions about whether a Masimo device properly set off an alarm before a patient died.
“It may well be that it’s a user error,” Zuckerman said. “But you have to investigate that and show that it’s a user error and not a device error.”
Zuckerman found it striking that the company refused to admit any wrongdoing to the FDA. “When a company refuses to respond in any way to the FDA other than to say that the FDA is wrong on every issue, that’s not very credible,” Zuckerman said. “Especially when users made complaints that the company’s product put patients at risk,” she said.
In an interview with ProPublica, Kiani again disputed the FDA’s findings, saying Masimo has always followed up on complaints. He said the company is cooperating with the regulator, providing it with information “to show them we did nothing wrong.”
When asked how the FDA findings reflect on the ideals put forth by his nonprofit effort, the Patient Safety Movement Foundation, Kiani said that he never claimed to be perfect. “I’m just trying to do my best and get my other colleagues to do their best, and put processes in place to hopefully minimize preventable death,” he said.
The two-year-old foundation has attracted a who’s who of top health care quality experts to its summits, including decision-makers from Medicare. The second annual conference was in January at the Ritz Carlton Hotel in Laguna Nigel, Calif.
The foundation promotes a “culture of safety” and encourages the early identification of problems that can lead to patients being harmed. “The lack of safety culture results in concealment of errors and therefore a failure to learn from them,” the foundation’s guidelines state.
One member of the foundation’s board said he was disappointed about Masimo’s alleged lack of response. Masimo “has to improve because [companies] are a big part of our ability to get to zero preventable harm,” said the board member, Dr. David Mayer, also a vice president of quality and safety at Medstar Health in Maryland. Mayer said he gets no compensation to sit on the board and pays his own expenses to attend its meetings.
The foundation’s president, Jim Bialick, said the organization is primarily funded by a charitable offshoot of the company, the Masimo Foundation for Ethics, Innovation, and Competition in Healthcare.
In response to a question about whether the FDA’s concerns would be addressed at the upcoming summit, Bialick said that was Masimo’s choice. “I would imagine it would come up. Whether Masimo brings it up, that’s up to them.”
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