Newly Released FDA Guidelines for Sepsis Detection & What it Means for Hospitals
By Tim Kuebelbeck, Chief Customer Officer, Ambient Clinical Analytics
Executive Brief
On September 28, 2022, the FDA released Clinical Decision Support, Guidance for Industry and Food and Drug Administration Staff. This guidance is long overdue, and with it comes the elimination of any protections for EHRs, or any other vendors, to pretend it’s OK to sell or deploy solutions for patient monitoring and care for life-threatening conditions like sepsis, that lack appropriate FDA-Clearance. To be clear, this has caused harm to patients for over a decade and will continue to do so until hospitals make serious efforts to follow the FDA Guidelines and police themselves. The leading EHRs in the U.S. have been linked as a principal cause of the U.S. having such poor sepsis compliance. Even some recently revised EHR detection models, likely won’t solve the previous issues and since the approach is only focused on detection and not the follow-through for the treatment process, will likely make little or no impact on septic patient outcomes. Many of the EHR solutions remain and will be for the foreseeable future, a non-FDA-approved solution. What is more, it’s not just EHRs, many other Clinical Decision Support and Population Health vendors are exacerbating the problem by selling ill-conceived solutions that do not have appropriate clearances into their customer base.
According to StatNews.com, “It was June 2021, and a study about to be published in the Journal of the American Medical Association had found that an EHR’s artificial intelligence tool to predict sepsis, a deadly complication of infection, was prone to missing cases and flooding clinicians with false alarms. Reporters were clamoring for an explanation…This EHR is not the only company moving aggressively to sell AI tools to health systems. But the precarious rollout of its popular sepsis algorithm has become a case study in the challenges of ensuring such algorithms are used safely and effectively at the bedside. It also underscores shortcomings in procedures for evaluating and regulating AI products, which risk giving faulty advice to doctors and nurses trying to make time-sensitive decisions about very sick people.” 1
The truth is septic patients pay the ultimate price for vendors and hospitals who willfully disregard the FDA guidance and those patients are being forsaken for vendor revenue and shareholder value by both vendors and hospitals. What it means for hospitals and health systems is that the days of using non-approved EHR based, or any other Clinical Decision Support tools, that lack the proper FDA Clearance is quickly coming to an end.
According to a short brief written by Dr. John Halamka, M.D., president, Mayo Clinic Platform, and Paul Cerrato, senior research analyst and communications specialist, Mayo Clinic Platform;
"The term software as a medical device (SaMD) may sound cryptic to anyone not familiar with health care IT. To explain the term, the U.S. Food & Drug Administration (FDA) quotes the International Medical Device Regulatory Forum’s definition: "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device." This kind of standalone software is having a major impact on the delivery of medical care worldwide, and has the potential to transform patient care in ways that were unimaginable a few years ago."2
While I’m sure many institutions saw or maybe even browsed through the newly released guidance, I’m guessing they didn’t give it a second thought. Case in point, yesterday I spoke with a nurse in a clinical/practice leadership position for a nationally recognized and leading healthcare system. She is heavily involved in managing sepsis and had no idea these guidelines were released a few weeks ago. Make no mistake, this guidance signals a monumental shift in direction for the FDA and puts every hospital in the U.S. on notice that they need to heed the FDA's new guidance and in short order start following the guidelines. The reality is that according to the new FDA guidelines, organizations that do not have FDA clearance should not be selling, installing, or operating sepsis solutions at a client site.
According to an article in Grey Matter Marketing, "Most medical device companies will agree with Tom Petty: the waiting is the hardest part. The time period from FDA submission to clearance or approval can feel like an eternity… A device that lacks FDA marketing clearance is considered "investigational," and therefore the company cannot promote, advertise or accept orders for it. The FDA considers such activities to be the commercialization of an unapproved device."3
FDA approval for sepsis solutions are monumentally important when it comes to outcomes. Sepsis is a medical emergency and if left untreated or not treated in a timely fashion, becomes a runaway train for a patient’s immune system. In an untreated environment, sepsis rapidly develops into a life-threatening medical event. It is critical to ensure that appropriate clinical therapies, commonly known as sepsis bundle elements, are delivered in the appropriate timeframe. Minutes can be the difference between tissue damage, amputation, long-term organ damage, and death. Septic patients who are treated in a timely fashion are much more likely to return to a normal life.
A few notable areas should be considered when looking at FDA-cleared sepsis solutions. One, hard reality around sepsis is: you have detected sepsis, then what happens? The vast majority of solutions that have and almost all that haven’t achieved appropriate clearance from the FDA have an extremely limited workflow behind them. That workflow is crucial to actually driving the delivery of the correct therapies in the correct time frames. Typically, these vendors have little clinical expertise nor the capacity to develop workable workflows to drive the delivery of the correct bundle elements. This type of workflow development requires a hospital customer who is willing to co-develop and codify the CMS requirements. Very few vendors have codified their products to meet CMS regulations and the Society for Critical Care Medicine’s Surviving Sepsis Campaign. Therefore, even if these companies do manage to acquire FDA clearance for their detection algorithm, they will still fail the patient when it comes to the delivery of the required clinical therapeutics because they lack the clinically appropriate workflows after detection. Because so many vendors are engaged in how well their sepsis algorithm performs, it is apparent many of the vendor don’t fully grasp that the algorithm is only a small part of the solution. The battle against sepsis is almost wholly contained in the workflow that follows and is what actually drives the correct care.
Two, is algorithm transparency. Singular black box algorithms from many of the EHRs and vendors, despite widespread deployment, have never been accepted in the industry. Whereas open and transparent algorithm that are configured based on customer location/site/unit have been better accepted by the clinical community and they make more sense.
While this guideline more clearly defines what requires FDA Certification, one has to wonder what the FDA’s plans are for enforcement. If you look at Hospitals around the US, I would estimate less than 1% have FDA-approved solutions for detecting and treating sepsis, hence the enormous problem we are facing in the U.S. and around the world for detection and treatment. Furthermore, if you look at the facts and figures for sepsis, it’s a losing game for both the patient in terms of outcomes and for the provider institution from a financial perspective, which leaves patients and hospitals at risk. With sepsis being the world’s leading cause of mortality both in and out of hospitals, perhaps this major course change within the FDA is signaling future enforcement.
Considering all the above, the release of these guidelines is very good news. As I stated earlier, patients pay the ultimate price for non-FDA-approved solutions. Hospitals and vendors that continue deliberately deploying & using non-FDA-approved solutions, according to the FDA, are now clearly doing so in disregard of the FDA's guidance. Hospitals wouldn't disregard the FDA for a bedside device or a medical implant that requires FDA approval, so why do hospitals choose to disregard FDA guidelines for sepsis solutions, it is no different. Once again, this leaves patients exposed to a major risk of death, amputation, and long-term organ damage, and hospitals at financial and publicity risk for huge settlements for malpractice.
In 2017 a Jury awarded $20M to the family of a Minnesota woman after she gave birth and died of sepsis. Since then this health system has revamped its sepsis program but with little or no progress toward meeting the required bundle elements and treatment protocols. Despite those efforts to improve, compliance is barely above 50%. For those not familiar with sepsis, compliance means patients that get the correct treatment protocols within the correct time frames as defined by CMS and the Society for Critical Care Medicine’s (SCCM) Surviving Sepsis Campaign. According to medicare.gov’s - Hospital Compare, which relies on self-reported data, this health system is only treating 51% of its patients with the required elements of care and within the time requirements. To restate this differently, for sepsis, which is a medical emergency, for patients at this flagship hospital, only 1 in 2 receive the right treatment protocols. That is a dismal figure and wouldn’t be accepted for any other medical condition. If you had a 50/50 chance of getting the right treatment for your ailment and needed to go to an emergency room, would you choose that hospital or would you choose one that is better? In this health systems defense, they are not alone. The national average for sepsis compliance hovers around 50-55%, which is still an atrocity. There are plenty of hospitals and hospital systems that perform in the 7%-40% range. There is a hospital system in Missouri whose sepsis compliance to the required CMS and SCCM Surviving Sepsis Campaign bundle elements is 7%, which is abysmal. Within the last two years, they chose a non-FDA-approved solution to drive their sepsis care. Another system that recently deployed a non-FDA-approved solution is hovering in the mid 40th percentile which is an improvement over their previous self-reported scores but still leaves roughly 60% of their septic patients at major risk of death and long-term health issues.
U.S. News and World Report annually compiles the Best Hospitals Honor Roll a list of, according to their rankings, the top 20 hospitals in the country. Out of the top 10 hospitals on this list, only NYU Langone, in New York, is above 70% for meeting the CMS sepsis compliance requirements and they scored a 79%. Some would argue this is a good score, and it is if you look at the national average. However, this means at least 2 out of 10 septic patients don’t get the appropriate treatment as per CMS guidelines and the Surviving Sepsis Campaign, which is totally unacceptable considering there are FDA-approved digital health tools on the market today that will drive that compliance well north of 79%. Even at 79%, although much better than the national average, is still not nearly good enough and is a far cry from 100%. The next best compliance for the U.S. News and World Report Best Hospitals Honor Roll was 60%. In terms of sepsis compliance, the worst performing hospital on the Best Hospital Honor Roll list would shock you, and they scored a 36%. The other seven U.S. News and World Reports Best Hospitals Honor Roll scored from the 40th percentile to the 52nd percentile. The Best Hospitals Honor Roll clearly doesn’t consider sepsis, if they did, it is likely NYU Langone might be the only one that remains on this list.
According to US News and World Report, specialty rankings and procedure and condition ratings are the two major criteria for the rankings. These rankings really focus on specialties' performance and appear not to be reflective of other performance criteria like CMS’s sepsis performance. My suspicion is if The U.S. News and World Report included sepsis scores in their rankings, all these health systems would begin deploying an FDA-approved sepsis solution that drives compliance. Keep in mind the vast majority of all these hospitals with performance problems are using solutions lacking the appropriate FDA approvals.
In the FDA Guidelines, it clearly states in Section 12, Pg 22, any software detection of a life-threatening condition, like sepsis, is a qualifying medical device. With this guidance, EHR companies, Clinical Decision Support companies, and Population Health companies that are currently selling solutions that don’t have FDA clearance should immediately cease selling and/or deploying sepsis or any type of decompensation detection system without obtaining FDA clearance first. Even now, companies that continue to sell and deploy solutions are doing so in a fashion that knowingly disregards the FDA Guidelines while intentionally putting patients in harm's way. This puts hospitals and more importantly, patients at risk.
The Answer
The good news is there are FDA Cleared solutions that address and solve all the preceding issues. A digital health solution with a sepsis detection algorithm and trusted sepsis notifications, are extraordinarily critical for patient outcomes. The World Health Organization states that sepsis is a condition affecting over 30 million people globally annually and is responsible for roughly 6 million deaths. The Centers for Disease Control and Prevention report that 1.5 million Americans contract the condition every year and approximately a third of these patients die. Sepsis is the number one killer across the globe and the number one killer in hospitals.
Hospitals have access to the correct data to treat sepsis, unfortunately, most have knowingly chosen to not deploy appropriate and FDA-approved digital health solutions to leverage that data and drive appropriate sepsis treatment. If they do have a digital solution to leverage the data, it probably isn’t an FDA-Cleared platform. Early and accurate sepsis detection along with trusted sepsis notifications, ensure treatment is delivered in the critical hours after diagnosis. If treated early and appropriately during the CMS-established timelines, for the most part, these become preventable deaths. Unfortunately, the disease is also notoriously difficult to diagnose. Chronic under-diagnosing, delayed treatment, missed delivery of bundle elements, and subsequent deaths are the motivation behind worldwide campaigns to improve sepsis recovery strategies. Today sepsis often results in extended and extreme care, including long ICU stays, where patients need a high level of monitoring and attention. These requirements make it a particularly expensive condition to treat, costing the US $24 billion annually.
While organizations like Sepsis Alliance, SCCM (Surviving Sepsis Campaign) & The Patient Safety Movement Foundation are doing incredible things to drive patient safety and sepsis awareness, a huge gap still exists in the general population on understanding the signs of sepsis. If recognized and acted upon, many patients would still have their legs and fingertips and many more would still be alive. In addition, these organizations appear focused on awareness of the clinical condition, which is good, but a large void exists in these organizations' understanding of the importance of an FDA-cleared solution that addresses Sepsis, and how that will push this worldwide sepsis problem in a positive direction. Again, the good news is that these organizations are driving awareness. Just this year, Governors in 38 states issued Sepsis Awareness Month proclamations for September. A far cry from 50 but more than ever.
Another major component of the answer is to keep in mind is that sepsis detection and sepsis alerts are only a fraction of the entire sepsis detection solution. Caveat emptor, or let the buyer beware. My warning to you is this; don’t select a company that focuses only on an algorithm, it is shortsighted since the problem and the answer are so much more complex than that. The end-to-end solution must be FDA cleared. If you reliably detect sepsis, well that’s great, but then what? Without a workflow that drives sepsis bundle compliance, or worse a limited workflow that is not codified to the CMS bundle requirements, you are still leaving your septic patients at risk. It will also cause your physicians and nurses to lose faith in the system. According to an October 11th, 2022 article in Becker’s citing a survey by Bain & Company, 25% of all clinicians want out of healthcare, and 89% of the claim burnout as the primary cause. The last thing you want to do as a hospital is to give your doctors and nurses ineffective solutions that continue to fuel their burnout.
As mentioned earlier, just like everything in healthcare, the answer to sepsis is complex--more so than just an algorithm or a workflow. So if you thought that’s it, think again. Not only do the algorithms and those workflows have to drive care, but to be effective, they have to integrate into your EHR and clinical communication tools like Vocera, Spok, Tiger Connect, or even pagers.
Beyond driving early detection and intervention with your detection algorithm, it is critical that your digital health and sepsis detection solution has sepsis patient tracker board functionality that provides automatic sepsis surveillance and at-a-glance awareness of patient status. At-a-glance situational awareness enables bedside and remote monitoring of large numbers of patients simultaneously. Also, verify that your digital sepsis solutions must employ two types of sepsis alerts. First, a Smart Notification™ that sends a sepsis alert to directly notify the right caregivers, at the right time, of potential sepsis in a patient. Second, using a Smart Escalation™, continues to notify caregivers via a smart sepsis alert until someone on the team takes the appropriate action. Unlike EHR’s, any true digital health platform will do this while graphically tracking the delivery of the sepsis care bundle and while providing a sepsis care reminder with both Smart Notifications™ and Smart Escalations™ for when elements of the bundle may be in jeopardy of delivery in a timely fashion.
Even the most vigilant nurses and doctors get tired, make mistakes, and miss subtle patterns.4 Selecting and implementing an FDA-cleared clinical decision support and digital sepsis detection and sepsis notification system for your hospital is crucial to early detection and in ensuring mistakes and missed cues are minimized. Make sure the vendors that you are evaluating have peer-reviewed published articles with major teaching or university health systems that scientifically prove the efficacy of their sepsis alert solutions. A sepsis alert, although very important, is only a portion of the entire sepsis solution.
Why do you need a complete solution? CMS data have shown that since implementation, organizations that deliver all the required care elements and meet the timeline requirements have significantly lower mortality rates for patients diagnosed with severe sepsis and septic shock5. In today’s age of digital technology, health systems are failing to recognize they are tying providers' hands by providing substandard sepsis detection-only solutions for patient care. Solving sepsis is not a detection algorithm race. Health systems continue to willfully ignore FDA guidelines and deploy non-FDA-cleared EHR based electronic sepsis detection solutions that have proven to be ineffective, rather than deploy FDA-cleared sepsis solutions. Sepsis solutions that are clinically vetted and FDA-cleared will facilitate accurate and early sepsis detection and more importantly, drive delivery of the sepsis bundle within the appropriate time windows. Carrying pocket sepsis bundle cards, using egg timers and other manual labor-intensive approaches is never an effective answer, and neither is a non-FDA cleared EHR deployed sepsis detection solution.
With the current best practice health system model of deploying a non-FDA cleared EHR based sepsis detection solution driving a U.S. national average of roughly 55% bundle compliance for sepsis, is it any wonder that health systems lose enormous amounts of money on treating sepsis patients? This means that little more than 4 out of 10 patients with sepsis receive appropriate treatment and signifies a massive failure in the current deployment model. The new FDA guidelines are a step in the right direction but need enforcement. The current EHR based strategy needs to be fixed and the FDA guideline update is a massive nod towards that end. Clearly, embedding something in the EHR isn’t the answer. In the U.S. for sepsis patients, care is falling short for half of them. We must do better.
Summary
Getting duped into believing your IT can build a sepsis solution for you in the EHR is unwise. We have seen this approach in health system after health system, and it never completely works. We have had encounters with one hospital in southern California that evaluated us two times and both times their CIO convinced senior executives he could build a solution in their EHR. That hospital is still hovering at 29% sepsis bundle compliance 4 years later. Because of this approach, seven out of ten of their septic patients don’t receive the appropriate treatment. Think of all the unnecessary pain and anguish inflicted on septic patients and their families because of a health system's continued reliance on the EHR for addressing sepsis. Considering a solution that is not FDA-Cleared and deploying it or continuing with a tool that is not FDA-cleared is setting your hospital up for a catastrophic mistake to occur. If a vendor hasn’t gone through the appropriate approval process already, there are several reasons for it. They do not have a viable peer-reviewed and published study proving the efficacy; the solution is not clinically designed and vetted; they do not have the clinical or regulatory expertise; or in the case of EHR vendors, they feel they are exempt from FDA oversight. Often, all these reasons apply.
Delivering appropriate care requires a multidisciplinary approach utilizing an FDA-cleared digital health communication platform. CMS data have shown that since implementation, organizations that follow all the steps have significantly lower mortality rates for patients diagnosed with severe sepsis and septic shock6. Digital health clinical decision support solutions specifically designed for sepsis with the appropriate approvals and certification drive compliance and reduce mortality.
The current health system model of deploying a non-FDA cleared EHR-based sepsis detection solution drives a low U.S. national of bundle compliance for sepsis7. This is a major contributor to why health systems lose enormous amounts of money on treating septic patients and have difficulty adhering to the CMS requirements for treatment. Nationally, roughly 1 in 2 septic patients receive the appropriate treatment. Which highlights a massive failure by hospitals and health systems in using EHR’s and other non-FDA approved sepsis alert solutions.
Would you allow for only 50% of your births or surgeries to be delivered or completed appropriately? If not, then why allow only 50% of your sepsis cases to be treated appropriately? The current hospital strategy for septic patients is broken and these newly published FDA Guidelines signal this needs to be evaluated and revamped. Today, we are consciously and deliberately failing in over half of the septic population when it comes to sepsis treatment, we must do better, and it all starts with FDA-Approved digital health, an effective sepsis detection and sepsis alert system.
Sepsis DART™
Sepsis DART™ is an FDA Class II Cleared and CE Marking Approved digital health clinical decision support tool that integrates with the EHR to keep physicians and nurses in their native EHR workflows while assisting hospitals with sepsis diagnosis, timely delivery and management of treatment, and reporting.
Sepsis DART™ - (Detection And Response Tool) is designed to analyze patient data and identify potential sepsis conditions early, offering medical staff the right information for detection, and using smart sepsis notifications & escalations to support tracking of the treatment process. Sepsis DART™ integrates its data visualization iconography into the EHR and works under the covers keeping physicians and nurses inside of the EHR workflow. Sepsis DART™ follows the patient through different hospital units, services, and environments. Sepsis DART™ is configurable for various institutional purposes and DART™ is malleable to other life-threatening conditions such as AKI, SSI, Stroke, etc... that require early detection and adherence to a specific clinical process.
Sepsis DART™ was clinically vetted with Mayo Clinic Rochester and has a strong Cost Benefit Analysis showing significant savings and an excellent ROI. The FDA requires that Sepsis solution vendors are Class two approved solitons, which we are. This allows us, along with the customer, to tune algorithms to fit any health system location. Ambient has also achieved CE Mark approval and ISO 13485:2016 certification. ISO 13485 is a quality standard specific to the medical device industry and is internationally recognized. ISO certification communicates a message to healthcare partners that certified companies like Ambient are world-class businesses capable of delivering value and long-lasting support. Through ISO, a company can demonstrate they have met the objectives of a rigorous standard of excellence which is extremely important to health systems and will enhance their competitive advantage.
The Sepsis DART™ alert system is a communication platform that integrates with your clinical platforms, monitors, and then communicates regarding all aspects of sepsis treatment bundles to the right practitioners at the right time, maintaining information on septic patients even between care locations and shifting staff. This reduces errors and omissions, as the entire care team understands on a real-time basis what treatment elements have and have not been delivered, and how much time is left to successfully complete treatment. Published research from Mayo Clinic shows that AWARE Sepsis DART provides a high level of sensitivity and specificity as well as improved compliance with sepsis treatment delivery guidelines. Because Sepsis DART keeps all pertinent data for each case in a single repository, all centrally available and correlated to the “time zero” of the sepsis event, the effort required to abstract and report on sepsis cases is substantially reduced.
1 Ross, Casey, Epic’s overhaul of a flawed Algorithm shows why AI oversight is a life-or-death issues, StatNews.com, Oct, 24, 2022
2Keeping Up to Date on SaMD Regulations, June 13, 2022, https://www.mayoclinicplatform.org/2022/06/13/keeping-up-to-date-on-samd-regulations/
3Miller, Halley, Promoting Medical Devices Prior to FDA Approval or Clearance, Gray Matter Marketing, Oct 19, 2015, https://www.greymattermarketing.com/blog/promoting-medical-devices-prior-to-fda-approval-or-clearance
4 Strickland, Eliza, Hospitals Roll Out AI Systems to Keep Patients From Dying of Sepsis, IEEE Spectrum, October 19, 2018
5 HHS.gov, Largest Study of Sepsis Cases among Medicare Beneficiaries Finds Significant Burden, HHS.gov, February 14, 2020
6 HHS.gov, Largest Study of Sepsis Cases among Medicare Beneficiaries Finds Significant Burden, HHS.gov, February 14, 2020
7 Castellucci, M., Just 49% of hospitals follow CMS’ sepsis treatment protocols, Modern Healthcare, July 27, 2018