Medical Device Daily Washington Editor

WASHINGTON — One of the morning sessions at this year's annual meeting of the Medical Device Manufacturers Association (MDMA; Washington) meeting was dedicated to a patient safety initiative spearheaded by device makers, and Joe Kiani, CEO of Masimo (Irvine, California), urged device makers to get on board a program he said might save hundreds of thousands of lives each year. The initiative could put device makers at loggerheads with providers given the call for new standards of patient monitoring practices, but there are a number of providers on board as well, making this a program with a broad base of support.

Kiani mentioned To Err is Human, the 1999 report by the Institute of Medicine regarding deaths attributed to medical mistakes, then remarked that a November 2010 report by the Office of Inspector General had alleged that 180,000 Medicare patients die in hospitals each year due to medical mishaps. "Worldwide we think the number is four million," he said.

Also on the dais for this session was Lenore Alexander, whose daughter Leah died from respiratory arrest, which was attributed to an overdose of analgesics administered to manage the girl's pain after a surgery. Leah Alexander is the inspiration for Leah's Law, a legislative proposal that would require that patient monitors be attached to anyone treated with opioid analgesics.

Alexander told the audience, "these mistakes happen because your products aren't being used properly," remarking that in this instance, device makers are "the good guys. I would hope that your products would be used in the way" they were designed, Alexander said, adding, "if they're not working to save patients, it's such a waste."

Michael Ramsay, MD, who chairs the Department of Anesthesiology at Baylor University Medical Center (Dallas), said this kind of program has been an imperative at Baylor for nearly four years. "In 2009, we had 49 calls in one month" to rapid response teams for patients whose conditions had worsened to the point at which their lives were at risk. "This had to stop. We couldn't keep up with 49 rapid response team calls," he commented.

"We brainstormed how to make this safer," Ramsay said, including provider education programs, but "even a nurse in the room with the patient couldn't detect whether someone was breathing properly" in many instances. He said possession of monitoring equipment is all good and well, but that the equipment "has to be accurate ... and continuous." He also argued, "the false alarms have to be dealt with because if the false alarms" result in a removal of the monitor, the patient is back to a high-risk predicament should his or her respiration ebb.

Ramsay argued that medical staff has to be more attuned to the equipment, too. "Someone has to monitor the monitor," he said, noting that at Baylor, "we've cut that 49 down to two to three calls a month" as a result of the program.

Filmmaker Mark Kassen, who produced the GPO-themed movie "Puncture," was also in attendance, stating that thanks to what he learned in the months since making the movie that he has developed "an insane amount of respect for what you all do."

Kassen said that the full needless death tally in the U.S., including non-Medicare patients, is probably in the range of 200,000, a population "people in the media industry don't know about." He said "this [predicament] doesn't have the voice it deserves."

Kassen mused that device makers are at the start of the patient monitoring development and usage chain, stating by way of comparison, "who has the final cut in our industry? It's the projectionist." He said that poor projection can ruin a perfect production effort, and reinforced his position by saying that a big problem is "the person minding the technology."

Ramsay picked up on that theme, saying that the problem is distributed across "a broad spectrum of people," adding that there are "many of [those stories] out there. We can prevent it. The technology is there. Let's enforce the [use of] technology," he said.

Ramsay argued in favor of monitoring checks every two to two and a half hours, posing the question of "why is it we're complacent? I think that's education." And while hospitals might assert that regulators are already breathing down their necks, Ramsay said "we need the regulations in place to have the monitoring out there" used appropriately.

Mark McCarty, 703-361-2519

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