Feb. 13, 2017
IRVINE, Calif. — Joe Kiani likes to point out that the most worn spot on most medical monitoring devices is the mute button.
He’s out to change that — and, he hopes, to stop the epidemic of preventable hospital death that kills tens of thousands of Americans each year.
It’s not a glamorous cause. And Kiani is not a household name. But he is a multimillionaire with a proven track record of using engineering smarts to fix dogged problems; he made his fortune improving the humble pulse oximeter, which measures oxygen saturation in the blood. Now, he’s pushing a nerdy, but elegant, idea for saving lives: prodding manufacturers of medical devices and electronic records to open their platforms so all the systems can talk to each other.
His tech fix — if widely implemented — could bring order to the cacophony of beeps, buzzes, and blaring alarms that can so overwhelm nurses and doctors that they push “mute” and miss true emergencies. It could make it easier for staff to monitor patients with complex needs. And it could flag, in advance, potentially fatal errors like incorrect dosing and drug allergies.
Manufacturers, naturally, aren’t so eager to share their computer code. But Kiani is not one to give up.
He stages a glitzy patient safety summit each year, attracting big-name speakers like Bill Clinton and Joe Biden to pound home the need for hospitals to stop killing their patients. “If President Clinton or Vice President Biden says it, it has far more weight,” Kiani said. “When I say it, it’s like a flea screaming.”
In the past five years, Kiani has encouraged — some would say browbeat and publicly shamed — 70 companies to sign a pledge to open their platforms. The group includes some of the biggest medical device manufacturers — who also happen to be some of his most bitter corporate rivals.
“It’s really surreal when I look at where we are,” Kiani said. “People who were our mortal enemies like Medtronic and Philips are now joining us.”
“He wondered: ‘Why are people going into hospitals and not coming out?’”
Frederic J. Harris, engineer and mentor to Kiani
Of course, making a pledge is one thing. Carrying it out is another. While smaller companies have been eager to open up their data, many heavyweights are moving slowly. Some cite concerns about patient privacy; others are working on big integrated systems to sell to hospitals and aren’t interested in cooperating with competitors. Makers of electronic health records have been especially reluctant.
Yet outside experts such as Dr. Peter Pronovost of Johns Hopkins University, a world leader in patient safety, see glimmers of hope.
Pronovost once thought it would take federal regulation to force companies to make their devices talk to one another, which he calls a crucial safety feature, akin to making sure a pilot can can check on the plane’s landing gear from the cockpit. He’s heartened by Kiani’s progress.
“When Joe first stood up and said he’d make data open, he was the lone wolf in the industry,” Pronovost said. “Most of the others put their heads down and stayed silent. He’s been a visionary.”
Zoll, which manufactures defibrillators and data systems in ambulances, was one of the first to open its data. Patient information captured in Zoll-equipped ambulances can now flow directly into the patient’s electronic health record, for review by hospital staff.
As a next step, CEO Rick Packer is pressing the health records companies to send data to his ambulance devices, so paramedics have crucial background on the patients they’re transporting.
“I use the data pledge as a moral high ground” in negotiations, Packer told a panel at Kiani’s patient safety summit last year. “Eventually it’ll come around and we’ll get what we need.”
A science geek hits it rich
Kiani runs his own medical device company, Masimo, from a building so airy and modern it stood in for Stark Enterprises in the first “Iron Man” movie.
With a volleyball court in the lobby and hemp milk and artisanal chocolate served in the employee cafeteria, the building pulses with California startup vibe.
Kiani, 51, a father of three with slightly silvering hair and a penchant for wearing dark tailored suits with no tie, lives in nearby Laguna Beach. But his life wasn’t always so easy.
When Kiani arrived in the US from his native Iran at the age of 9, he spoke three words of English. His family settled in tiny Albertville, Ala., because his father, a technician, had a friend there. (Many who admire Kiani note he’s the kind of successful immigrant who might be barred from the US under President Donald Trump’s temporary immigration ban.)
Kiani raced through high school, finishing at 15, and planned to become a doctor. But chemistry at San Diego State University foiled him. Instead, he turned to engineering.
“It’s probably better he didn’t become a doctor. He wouldn’t have saved nearly as many lives.”
Dr. Steven Barker, chief scientific officer, Masimo
“It’s probably better he didn’t become a doctor,” mused Dr. Steven Barker, a professor emeritus of anesthesiology and aeronautical engineer at the University of Arizona who now works as chief science officer for Masimo. “He wouldn’t have saved nearly as many lives.”
Soon after graduating, Kiani got a chance to work on pulse oximeters. The geek in him was captivated. “I couldn’t believe you could shine light in your finger and measure oxygen in your blood,” he said. “I just loved the idea.”
But devices being used in the mid-1980s were terrible. Just about any patient movement caused the devices to sound a false alarm that oxygen levels were low. Patients would then be blasted with too much oxygen, which often led to blindness in premature babies.
Drawing on what he’d learned from fields like submarine warfare and satellite communication, Kiani and colleagues came up with adaptive algorithms that helped the oximeters ignore signals that made no physiological sense. That cut down on false alarms and improved reliability. In 1989, Kiani and engineer Mohamed Diab launched Masimo. It began, as so many of California’s great companies have, in a garage.
The next decade was tumultuous. Bigger companies were trying to steal his ideas. Kiani couldn’t seem to get hospitals to look at his device. At times, his sales reps were even physically escorted off hospital grounds.
“It was so frustrating. I can’t even tell you,” he said.
Kiani had stumbled into the scandalous world of hospital GPOs, or group purchasing organizations. His pulse oximeter was being locked out by larger competitors who paid hefty fees to hospital purchasing agents in order to land exclusive sales contracts.
Kiani was initially afraid to get involved, not wanting his young company to be blackballed. “It wasn’t in my personal interest to try to change this industry,” he said. But he did speak out, in a series of high-profile articles and in testimony before the Senate in 2002.
“He really helped open up the market for smaller companies that had better, disruptive technologies,” said Ronald Newbower, an MIT-trained physicist who’s spent decades using technology to improve patient safety at Massachusetts General Hospital.
As hospital purchasing rules began to change, Kiani’s company began selling huge numbers of pulse oximeters. It is now one of the top sellers in a market estimated at $1.5 billion globally.
The company is moving into other areas, including brain monitoring. Kiani is extremely proud of Masimo’s technology and the sleek, iPhone-like devices he’s been creating of late. But the company took dings — and received an FDA warning letter in 2014 — for not adequately responding to complaints about some of its devices. Kiani said the company has since overhauled that process.
“His life story reads like a fairy tale.”
Former Senator Barbara Boxer
Masimo went public in 2007, and Kiani, still at the helm, is rich beyond his dreams. (Masimo’s board balked at his lucrative contract a few years ago and renegotiated, but he still takes in more than $5 million a year.)
“His life story,” said retired California Senator Barbara Boxer, a close friend, “reads like a fairy tale.”
But his business success wasn’t enough. The fight to open up hospital purchasing practices had stirred an activist bent in Kiani. He soon found his target.
Turning patient safety into a glitzy cause
After years of working in the medical field, Kiani knew the grim statistics: Some 100,000 patients in the US die each year of medical errors, according to a 1999 Institute of Medicine report. Some researchers, using newer screening tools, think the number could be four times higher. Others say it’s lower.
But everyone agrees these deaths can and should be prevented.
When Kiani began to put faces to the statistics, he was shaken.
One of those faces belonged to 11-year-old Leah Coufal, who died in December of 2002 at Cedars-Sinai Medical Center in Los Angeles. She’d had routine surgery to correct a mild chest deformity and apparently received a massive dose of fentanyl to control pain — enough to stop her breathing.
Her mother, Lenore Alexander, couldn’t talk about Leah’s death for a decade. When she started speaking out, Kiani listened. He was shocked to realize his own daughter — who is fine now — had surgery in the same hospital, with the same surgeon, in the same week as Leah.
“That could have been me,” Kiani told the people gathered at his first patient summit in 2013. “It could have been you.”
He was also shocked to find Leah had not been monitored after surgery, not even with a simple pulse oximeter. Another name Kiani couldn’t keep out of his mind at the time was Rory Staunton, a 12-year old from New York who scraped his arm in gym class, then died from a sepsis infection that simple screening tools could have detected.
“He wondered: “Why are people going into hospitals and not coming out?’” said Frederic J. Harris, an electrical engineering professor at San Diego State University who taught Kiani and remains close to him.
Kiani decided to tackle such senseless deaths through engineering.
“God bless him. He’s working on this and he’s got people all over the place working on it,” said Alexander, Leah’s mom, who has spent years pressing to get patients monitored after surgery. “I believe he’s a really good man. He’s not doing this for his own pocket.”
Critics, however, look askance at the high glitz content of Kiani’s annual summits, run through his Patient Safety Movement Foundation.
Held at beachside hotels, with splashy staging and tickets priced at $500 to $1,000 apiece, the summits rely heavily on political star power. (This year, for instance, the foundation is dangling a private fishing trip with Jimmy and Rosalynn Carter as a prize; health care institutions can enter to win by committing to specific steps to reduce patient deaths.)
“I’ve seen very little substantive action coming from this particular patient safety organization. I don’t see the results to justify the costs.”
Beth Waldron, patient safety advocate
Some critics also raise questions about the money Kiani has handed out to politicians. His foundation, which is funded by Masimo and other corporations, paid $315,000 to Clinton for a 2014 speech (though the former president has waived his fee for the past three years, Kiani said). Another of Masimo’s foundations has contributed $2.5 million to the Clinton Foundation.
“That’s a lot of money. You wonder if it’s a way to legally channel money to a candidate,” said Beth Waldron, a patient safety advocate and consultant in Chapel Hill, N.C. She once hoped to work with Kiani on her key issue — death from venous thromboembolism, or blood clots — but grew concerned after looking at how the foundation operates.
“I’ve seen very little substantive action coming from this particular patient safety organization,” said Waldron. She notes that plenty of other groups also work on patient safety and, in her view, get more done. “I don’t see the results to justify the costs,” she said.
Kiani said he resents any implication that he’s trying to buy access to promote his company or alter tax policies that affect his industry.
And many in the field, even competitors, say Kiani’s work is making a difference, by turning a spotlight on the uncomfortable topic of patient death and also by reshaping market forces.
“The pledge for open data does make an impact. Customers are starting to demand it,” said Stefan Dräger, the CEO of Germany’s Dräger, a medical technology manufacturer which signed up early on. He predicts more and more companies will jump in: “They have to,” he said. “It would look awkward if they refused.”
Medtronic, a medical device giant, has started to embrace open platforms, including in some of its insulin pumps and glucose monitors. Another powerhouse, Philips, has been working to develop industry-wide standards so devices can talk to each other.
Electronic medical records makers also need to come aboard, noted Johns Hopkins’s Pronovost, or they risk becoming “dumb data entry and billing systems” without access to the streams of data coming in from monitors and devices — or the powerful analytic tools used to make sense of it all.
Ed Cantwell, who runs the nonprofit Center for Medical Interoperability, said it’s a national embarrassment that companies have been allowed to own patient data instead of sharing it.
He’s working to create the architecture that hospitals could use to network their tens of thousands of devices into what he calls a “truly neutral, two-way plug and play” system. Once those standards are in place, he said, “I’m going to call vendors on their data pledges — very publicly.”
That can’t come too soon for Kiani. He’s already revved up about what it could all mean: Once more devices are linked and data is flowing, he said, computers should be able to predict in advance which patients are headed for trouble and alert clinicians. All that’s needed, he said, are a few good algorithms.
“It’s easy for a computer to do,” Kiani said. “It’ll be phenomenal.”
About the Author
Thank God for this modern day David who is fighting such intransigent Goliaths of our healthcare system.
GPO’s, a less than open and honest safety culture in our medical centers, and the “silo-ization” of data are strong barriers to optimal and safe patient care. I believe Mr. Kiani’s vision for zero preventable deaths in 2020 has been fought with incredible heart and generosity.
I respectfully disagree with Ms Waldron’s assertion that she has “seen very little substantive action coming form this particular patient safety organization”.
She may have neglected to review the three main ways the Mr. Kiani and his patient safety foundation have saved lives.
The development and use of Actionable Patient Safety Solutions (APPS),
concrete commitments from hundreds of hospitals to adapt the foundation’s APPS and finally, healthcare technology companies pledging to make data open and available are just three of the measurable actions initiated by the Patient Safety Movement.
These APPS, and institutional pledges that keep hospitals and clinicians PUBLICLY accountable have resulted in documented and measurable lives saved. Again, data that is real.
If that life is one of a family member or loved one… that to me is “substantive action”.
And whether we like it or not, the government is involved in our healthcare domestically and abroad.
Therefore, it is of course logical and smart of Mr. Kiani to enlist our elected representatives along with other international health care experts past and present to give heft, strength,and publicity to the fight against preventable patient deaths.
The monster achievement of getting the hospital’s C-Suite to become open and honest about the preventable medical/patient care errors in their centers is now reverberating domestically AND internationally.
The Patient Safety Movement has encouraged timely identification of the error, apologizing to the family and immediate remedy of the situation if possible.
The patient and family are listened to, respected, not sidelined and shamed. The staff and executives learn and improve their system of care. This improvement is shared in the greater medical community thanks to Mr. Kiani.
This a change that will now become a norm in the future cultural leadership of hospitals .
Most importantly, it appears the Patient Safety Movement gives the families of the aggrieved a forum to tell their powerful stories with honesty in a setting where hospital administrators, clinicians and health care technology innovators are in attendance. This gives added dignity to the lives of their lost family members. Especially, when during their hospitalization, that dignity, voice, and concern was possibly ignored.
Those stories stay with you forever and will hopefully inform the conscience of all those in attendance with their practice and innovation every day.
Upon further examination, another fire that the Patient Safety Movement has ignited is getting competitive healthcare technology companies (who have often been rivals in the marketplace) to begin to collaborate and share their data for the optimization of patient care and safety .
As a former critical care nurse, I of course believe better staffing with lower nurse to patient ratio’s is one of the most important factors in optimal patient care and safety.
There is no substitute for the ears, eyes, and hands of a bedside nurse who actually has time to assess and care for her patient proactively anticipating the next possible crisis or success.
Todays medical technology is part of that assessment and care.
It must be OPTIMIZED not IGNORED (muted).
I only pray this visionary David who has begun to challenge the Goliaths of the healthcare system whom impede optimal patient care and will not give up his fight.
Thanks to Ms. McFarling for bringing the story of this movement to light.
That was a nice essay Ms. Unidentified RN, and you made some salient points regarding the use and disposition of EMR systems. But if you think that because a good and viable EMR system is in place it will result in physicians and other medical personnel — and most especially Hospital Administrators — openly admitting to medical errors, report those they see other physicians, etc., making and then apologize to the patient/family and actually perform medical procedures to attempt to ameliorate the, sometimes devastating, result of those errors, you are living in Neverland. The AHRQ has a reporting system in place right now that is simply not utilized ninety percent of the time. What is going to ultimately reduce the horrifying numbers of these errors in any signifiant way is by patients becoming educated to the fact that two-thirds of the physicians and staff they rely on in the medical arena do not care whether the errors are reported. All they care about is the relative liability they face should that error be discovered; whether that be by them reporting it or by someone else discovering it and reporting it. Physicians, especially, cover for each other; even to the point of committing perjury in courtrooms. I’ve seen it done. I’ve seen physicians alter records, lie in records and simply refuse to record a procedure result at all in order to cover themselves or a colleague. Excuse me for being cynical, but I am. I lost my wife, with whom I would have gladly traded places, because a board certified oncologist either didn’t read a pathology report or he is blithely unaware of the type of biopsy that is required to accurately diagnose lymphoma. That error turned into a treatment error, which resulted in a HAI. That turned to Sepsis because it wasn’t detected and treated long before it got to that point and then she got another HAI from a physician who inappropriately attempted an extubation before she was strong enough. Yes, I’m cynical. I hope this guy helps the situation as much as possible; but until a culture of deceit, malfeasance and a narcissistic, entitled attitude by most medical professionals is exposed and its perpetrators humiliated, this system of serial killing is not going to stop.
If true, a breath of fresh air at last! Signed, a frustrated old nurse. So tired of learning new EHR charting and isolated towers of data that don’t talk to one another.
Karen Hamick
I can’t believe what I read about these babies.
The children mentioned in this story are just two of many, many thousands that die each year from Preventable Medical Errors. If you include those that suffer “serious harm”, the numbers go into the millions. And these are all errors that could be prevented. Physicians run on what I call “auto-pilot” most of the time. Sort of like how most of us drive a car. We are so used to doing it every day, we begin doing things like talking on the phone, texting, eating, etc. which cause us to not pay close attention to the task of driving. Imagine a doctor doing similar things with his focus and attention to detail when reading a pathology report or performing some surgical procedure; or even running through a problem solving protocol. He or she can miss something and end up prescribing the wrong chemo regimen or failing to properly suture an aneurysm, or missing a serious infection such as sepsis because he/she assumed that some confusion in the patient was caused by the cancer moving to the brain, when sepsis clearly causes confusion. By missing the sepsis, it gives the infection more time to take hold and cause problems that could very well become life threatening. The issue of unreported medical errors is killing people by the hundreds of thousands every year.
What this man can do if he really, truly, wants to ameliorate preventable medical errors and the hundreds of thousands who die because of them every year — including my beautiful wife — is to use some of those millions of dollars he has to publicize, expose and humiliate most of the physicians in this country who refuse to report, or acknowledge in any way, medical errors when they happen; and when they see one of their colleagues commit one as well. The OIG at HHS reports that only twelve percent (12%) of all medical errors are actually captured by reporting mechanisms installed at hospitals throughout the country. This reporting program is called The Common Formats that are the creation of the AHRQ, but have no enforceable penalty, intrinsic to the system, that kicks in when a minimally acceptable percentage rate of reporting is not met, so that the hospitals that are violating the reporting code will suffer financial and, possibly, criminal consequences when people die from these errors. Most especially when the errors are caused by gross negligence.
Larry Pierce you make some good points and also have a personal experience of medical error. Why not get involved and be a part of the solution? We need all the help we can get! Lenore Alexander http://www.Leahslegacy.org
Joe Kiani “made his fortune improving the humble pulse oximeter, which measures oxygen saturation in the blood”. One of the major uses for his Masimo oximeter is to regulate the arterial oxygen concentrations in the blood of premature babies because too much of that oxygen breathing help is said to be the cause for the baby-blinding epidemic retinopathy of prematurity which is a major cause of childhood blindness in intensive care nurseries around the world.
Several recent clinical trials claimed to reduce the incidence of this blinding by reducing the arterial oxygen concentrations, but typically the mortality in the low-oxygen groups of those studies was higher than in the groups with more generous oxygen levels. In effect, the tighter control of the oxygen killed some “extra” babies to protect them from having to grow up blind, but several medical enthusiasts advocated anyway to restrict the oxygen, presumably because hospitals are more likely to get sued for having blinded a baby than for his or her death which is easier to explain away as a natural result from prematurity.
A further fatal fallacy behind this use of Masimo’s fancy oxymetry technology is that the retina has its own oxygen supply which is independent of the arterial concentrations, and that restricting the latter in hopes to influence the former is as hopeless as trying to derive your birth date from your equally unrelated phone number. This has been known since the 1920s but is still conveniently ignored among nursery doctors and device makers.
Moreover, the entire doctrine about arterial oxygen levels causing the retinal damage is based on a research fraud in the 1950s when the doctors in charge believed the blinding was due to “defective germ plasm”. Their solution was to eliminate the “defective persons” afflicted with this problem, and the most obvious way to do so was to suffocate the supposed carriers of this defect by restricting their oxygen breathing help. This oxygen had long been saving the lives of the babies with the most immature lungs who were also the babies with the most undeveloped and therefore most vulnerable retinae. By the time those eugenicist doctors rigged their experiment, oxygen had been administered freely and generously for many decades without ever causing any eye damage at all. However, those doctors willfully ignored this fact and withheld all breathing help from virtually all the babies in the 18 trial hospitals for the first two days and then only enrolled the survivors in their trial. This Draconian measure killed the most vulnerable babies, and there was little eye damage among the survivors. The deceptive trial designers did not include the victims of this initial asphyxiation in their comparison and touted this reduction of blinding as a great victory over the retinopathy epidemic without warning about the deaths it had caused. Their authoritative edict caused intensive care nursery doctors around the world to drastically restrict oxygen supplements, and this is still the basis for today’s baby-suffocation policies and the eager but often deadly use of costly oximeters for measuring and adjusting irrelevant data.
Completely lost in the medical stampede towards restricting the oxygen was and remains the fact that the blinding had started in the U.S. the year after the introduction of fluorescent lamps, and that the same parallel was repeated after World War 2 in many other industrial countries as soon as these lamps became available there. Fluorescent lamps of most types emit a strong radiation spike at the wavelength of 435.8 nanometer which is right in the middle of the most intense “blue-light-hazard” to the retina, as established in many detailed studies by Industrial Safety experts. The typical intensive care nursery lighting over-exposes the still developing and therefore most sensitive retinae of the preemies in just a few minutes to the danger limit for such irradiation which the U.S. Industrial Safety Guidelines have established for adult industrial workers over an eight-hour shift. To counter the public concern about this over-exposure, a team of pediatric retinal surgeons rigged another trial in the 1990s in which they patched the eyes of the babies in their allegedly “protected” group only up to 24 hours after birth when these eyes had been just as over-exposed as those in the control group. Their contrived result of no difference in the blinding rates allowed them to claim the innocence of the nursery lamps in the blinding, and this bogus result is now enshrined in the pediatric dogma. This allows the continuation of the expensive oxygen controls, the regular eye exams by highly paid specialists, and the steady stream of captive customers for pediatric retinal surgery to try and patch up some of the eye damage caused by the willful ignorance of the nursery doctors.
For a documentation of the above statements, see http://retinopathyofprematurity.org/01summary.htm, and for more details of the continuing euthanasia program against the “defective” babies, read the rest of that site, and particularly http://retinopathyofprematurity.org/65OngoingEuthanasiaProgram.htm.
The story about the 11 year old dying from the Fentanyl overdose is saddening yet many children remain at great risk of this today. The dosing guide most paramedics use today only lists the intubation dose of Fentanyl, which is a 6-fold higher dose than the pain dose. As a disclaimer my company is fighting this battle so a COI does exist here. The main point is that often times solutions to serious issues don’t have to be complex. We applaud Kiani in this fight to improve safety and quality in healthcare.
Well balanced and well written piece about a topic that needs lots of attention. You die from medical mistakes if you are lucky. If you don’t, you may end up like my closest family member that was comatose 26 years leaving young children without their mother. It wasn’t a device that harmed her but a simple CAT scanned might have saved her. Instead, she had rushed visit to a specialist that stuck his finger down her throat to feel around, pressing hard enough against her neck to harm the artery and cause 2 massive strokes.
Recently I had to request all my medical records. I was horrified by the errors of simple yes/no medical history questions and also noticed that one dr wrote her notes very defensively (to the point if not being accurate) so as to protect herself from potential lawsuits.
So, insist on reviewing any medical information taken at the time of the appointment for accuracy. Once errors are on file, Dr’s are making diagnosis and decisions based on inaccuracies.
I suggest you call Kiran Patel. If you can make a believer of him, you’ve got a plan…
This
Hospitals don’t want to hire more Nurses, but the fact is, they should and anyone with a logical mind knows therein is the stress reliever and the solution to this dilemma.
And Sepsis. Sepsis kills far too many patients who come in fairly healthy and leave dead. Sepsis is something that should be front and center of every patient and their families. I think hospitals have to do a far better job here.
Nobody denies the importance of Nurses. And, until a hospital adopts a culture of listening to nurses, including them in rounds etc you could have 3 nurses per patient and the outcomes will not change.
Sepsis is a big problem. New York has put Rorys regulations into effect preventing hundreds of cases of Sepsis. We need every state to do this. It all sounds so simple until it really isn’t.
Truth is Nurses are ridiculously OVER LOADED with MORE patients than they can care for. While preventing the “mute” button from being used is important, it’s also self serving in that more money will be generated to the companies that create this; but it won’t cure the real problem. Hospitals don’t want to hire more Nurses, but the fact is, they should and anyone with a logical mind knows therein is the stress reliever and the solution to this dilemma.
A better way to prevent unnecessary Hospital deaths is to hold the Cleaning Crews and their Unions ACCOUNTABLE for the works they “claim” to do, but do NOT do. Beds and bathrooms are NOT properly cleaned or disinfected. The MUTE BUTTON is NOT the problem. Greed is the problem.
Joe Kiani has always said somebody has to monitor the monitors. Meaning it must be a closed loop system. This is a separate issue from HAI. And is not about greed. It is about creating systems in our hospitals that are smart and effective to keep our loved ones safe. Saving lives also saves hospitals millions of dollars, which we know is important. And when the life you have lost is your 11 year old daughter that doesn’t seem like too much to ask.