The American producer Samuel Goldwyn once quipped, “The hospital is no place to be sick.” In the decades since, his words are still relevant as a tragic irony: more than 200,000 people die each year in hospitals from preventable causes such as hospital-acquired infections, gross misdiagnoses, and medication errors. There is no lack of terrifying statistics to describe that figure; it is equivalent to one jumbo jet crashing each day year-round, and results in more deaths than highway accidents, breast cancer, and AIDS – combined. But perhaps the most eye-opening way to convey the patient safety issue is through the spate of media reports about patients who arrived at a hospital with a seemingly benign or treatable condition that, through a series of systemic failures, led to their deaths. One of the causal issues with the modern-day hospital is that many of the devices are not integrated. Since they are made by different manufacturers who have little incentive to collaborate, these devices operate as if they are individual players in an incoherent orchestra. Though there may be an expert-yet fallible-conductor (the clinician), if the players don’t listen to each other and work together there’ll still be too many inexcusable errors.
In order to address this, the CEO of one of the leading medical device manufacturers, Masimo, has written a Patient Safety Pledge that hopes to “create a movement of industry collaboration and ‘co-opetition’ that will remove the device and information barriers that are plaguing patient safety.” The call to action, which will be given by former President Bill Clinton, will officially take place next week at the inaugural Patient Safety Science and Technology Summit in California. This author had the opportunity to learn more about the pledge (full text below) and the summit by speaking with Masimo’s CEO Joe Kiani and his counterpart in academia, Dr. Peter Pronovost, who directs the Armstrong Institute for Patient Safety & Quality at Johns Hopkins.
Shiv Gaglani, Medgadget: What is the patient safety pledge?
Joe Kiani, Masimo: The idea behind the pledge is simple: we want to get healthcare’s decision makers to cooperate to prioritize patient safety, beginning with sharing patient data. CEOs of medical technology companies and large hospitals take the pledge to work towards making patient data available for R&D purposes, instead of getting bogged down with standardization issues which could easily derail us for another 30 years – and, frankly, in this day and age, it’s easy to make anything communicate together once you have the blessings of the maker of the product. By making the pledge and sharing patient data in a HIPAA-compliant way, these decision makers are doing a great service because smart people from all around the world can use those mounds of data to figure out how to make patient care better. Losing proprietary access to data is a small price to pay for preventing the 200,000+ preventable deaths that occur each year in our hospitals.
Medgadget: How did you come up with the idea of the pledge?
Kiani: The idea of opening data has been brewing in my head for a while because I’ve noticed how so many medical products are in their own separate silos. Permission to access this data is hard to come by, and as The Wall Street Journal articulately described this past November, even patients cannot easily access data from certain devices – even when those devices are inside of their own bodies. This is not a formula for progress.
I decided to turn the idea of the pledge into a reality following the tragic story of 12-year old Rory Staunton, which was profiled in the New York Times this past summer. Only a few days after suffering what appeared to be a minor cut from a fall in his school gym, Rory passed away from a septic infection. The data to save him was there – it just wasn’t following him as he visited his providers, and so no one connected the dots. I can’t help but imagine what would have happened if we had all shared our data 5-10 years ago. There would likely have been products capable of integrating the disparate sources of data and, in Rory’s case, notifying his family and doctors that he had something worse than stomach flu.
Medgadget: And how about the idea for the inaugural Patient Safety Summit?
Kiani: The idea for the summit preceded that of the pledge. I remember that Institute of Medicine report “To Err is Human” about how 100,000+ people died each year from preventable medical errors. At the time people thought that was exaggerated at best, a fluke at worst. Well two years ago Medicare found out almost double that number of Medicare patients perish from preventable deaths, so this is a trend that is potentially getting worse.
Many conferences I go to are either looking in the rearview mirror or they are looking so far in advance that there are no actionable steps that people can take to alleviate the problem here and now. Maybe everyone is waiting for everyone else to do something about it. The goal of the Patient Safety Summit is to come up with a few tangible ideas each year that can be implemented now – whether they are new processes, technologies, drugs, etc – that people can go out and implement to ameliorate the patient safety problem. We will also track our progress, so that this doesn’t become a once-a-year event, but rather something we are working on constantly.
I asked Peter [Pronovost] about nine months ago if he would agree to attend, and once he said “yes” I was off to the races. Later that year I had the opportunity to accompany President Bill Clinton on a week-long trip to Africa and noticed how, wherever we went, he was emphasizing cooperation. That’s why we’re having him keynote the Patient Safety Summit: to discuss cooperation for the sake of patient safety.
Medgadget: Speaking of cooperation, how does the government factor into this initiative?
Kiani: It is my hope that the Summit will not be a one-off event, and that hopefully we will be able to get government involvement next year and have them encourage this Patient Safety march. The goal with the pledge, however, is to motivate stakeholders to voluntarily cooperate to prioritize patient safety; that would be preferable to forcing stakeholders to do what is right through laws.
Medgadget: How did you and Joe Kiani at Masimo begin collaborating?
Dr. Peter Pronovost: Last year I hosted a patient safety meeting for medical device manufacturers at the Armstrong Institute. Joe was there representing Masimo, which makes many of the patient monitors you see in hospitals (e.g. pulse oximetry). We also had CareFusion, whose products include IV infusion pumps – which factors into the following story.
I opened the meeting with the device manufacturers by telling them the story of a healthy 11-year old girl, Leah Coufal, who passed away in a hospital bed from an overdose of narcotics. Her IV infusion pump kept delivering narcotics despite the fact that her respiration rate had become dangerously low. After showing them a picture of Leah, I said, “You guys are in part responsible for her death. If you allowed your devices to talk to each other then we could potentially have detected this problem and Leah would still be alive today.”
Joe Kiani got up and said, “Peter, you’re absolutely right – we have to change this.” We’ve been kindred spirits since and have followed up in bringing together the summit and pledge that we hope will get more medical device manufacturers to collaborate in sharing data, for the sake of patients.
Medgadget: What do you expect the pledge to accomplish?
Pronovost: There’s been a lot of effort going towards making “standards” for data sharing. Unfortunately, many companies may be hiding behind this call for standards as an excuse to not share data. Joe and I believe that if we can bring together a group of progressive CEOs to agree to sharing data – a purpose of the pledge – the younger generation will be able to figure out what predictive algorithms make the most sense to help avoid preventable deaths, as was the case with Leah. Yes, we need standards, but in parallel let’s let people start making advances using the data that can literally save lives.
The full-text of the pledge is below…
As leaders of our respective industries/professions, I believe that we must be collectively committed to improving patient safety.
I invite us to treat the patient data that clinicians and patients buy our products for, including those coming from electronic medical records, infusion pumps, anesthesia machines and physiological monitors, as the patient’s data and use them to empower patients, clinicians, and manufacturers to do what is best for those patients, regardless of where or when the patient’s care is being provided.
Toward that end, I pledge, on behalf of myself and my company, to make the physiological parameters displayed by my company’s products, subject to all applicable privacy laws, available to anyone or any entity that wants to use it
to improve patient care. And I expect to be held accountable for this pledge by others in the industry.
This is my pledge to making a better healthcare system, one step closer to ensuring there will be no more preventable deaths.
Please join me in making a pledge to make patient data that clinicians and patients buy our products for available to others in the industry for their use, a pledge that will save lives.
Yes, I want to make this pledge and hope to be held accountable for it:
Founder, Chairman & CEO