Episode #174 The Intersection of Emerging Medical Technologies and Anesthesia Patient Safety: The 2023 APSF Stoelting Conference

October 31, 2023

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Welcome to the next installment of the Anesthesia Patient Safety podcast hosted by Alli Bechtel.  This podcast will be an exciting journey towards improved anesthesia patient safety.

Our featured topic today is the 2023 APSF Stoelting Conference, “Emerging Medical Technologies – A Patient Safety Perspective on Wearables, Big Data and Remote Care.” Check out the full livestream here.

Special thanks to Bob Thiele for contributing audio clips to the show today.

We covered the Keynote Address: “Can Technology Improve the Value Equation in Healthcare?

Can Technology Improve the Value Equation in Healthcare? By Lee A. Fleisher.

Next up, the first session: Wearable Devices and Remote Monitoring, moderated by JW Beard.

This session includes the following talks:

  1. What is the Internet of Medical Things (IoMT)? By Anura Fernando
  2. Acute Care and Wearable Technology by Ashish Khanna.
  3. A Health Care Payer’s Approach to Value-Based Care and Innovation by James Grant.
  4. Wearables – Consumer v Medical Grade/Regulatory Perspective by Dheerendra Kommala.

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© 2023, The Anesthesia Patient Safety Foundation

Hello and welcome back to the Anesthesia Patient Safety Podcast.  My name is Alli Bechtel, and I am your host. Thank you for joining us for another show. We have an exciting show for you today all about emerging medical technologies! That’s right, we are covering the APSF Stoelting Conference and discussing some of the important takeaways from the conference that took place September 6-7th, 2023.

Before we dive into the episode today, we’d like to recognize ICU Medical, a major corporate supporter of APSF. ICU Medical has generously provided unrestricted support to further our vision that “no one shall be harmed by anesthesia care”. Thank you, ICU Medical – we wouldn’t be able to do all that we do without you!”

Our featured topic today is the 2023 APSF Stoelting Conference, “Emerging Medical Technologies – A Patient Safety Perspective on Wearables, Big Data and Remote Care.” To follow along with us, head over to APSF.org and click on the Conferences and Events heading. Second one down is APSF Stoelting Conference 2023. Then, you can watch the livestream events of the two-day conference. Before we start talking about the Keynote and first panel, let’s meet one of the conference attendees.

[Thiele] “Hi, my name is Bob Thiele, and I’m a critical care anesthesiologist at the University of Virginia, and I’m on the APSF Committee on Technology.”

[Bechtel] To kick off the show today, I asked Thiele “What were the most important takeaways from the conference for you?” Here is what he had to say.

[Thiele] “How dangerous it can be to accept artificial intelligence blindly. The best examples come from predictive monitoring. It is possible to detect statistical associations in patient data and outcomes that appear robust, despite the fact that the models have no basis in underlying physiology or science.

And this is true across industries. Google’s alpha fold, for instance, can predict protein shapes, but it has not actually solved the problem of learning which rules govern protein folding. The problem is that while the forces that govern protein folding have not changed in billions of years, the forces that influence behaviors in hospitals change daily.

So, an AI model built in 2022 may be completely useless in 2023 unless it has actually developed some immutable understanding of how hospitals, providers, physiology, or pharmacology work.”

[Bechtel] Thank you to Thiele for highlighting these considerations that will likely have important patient safety implications going forward. And now, the 2023 Stoelting Conference.

First up is the Keynote address by Lee Fleisher, “Can Technology Improve the Value Equation in Healthcare?” The value equation in healthcare is represented by the Quality, the combination of medical outcomes and patient experience, divided by direct and indirect cost.

Fleisher kicks off his address by highlighting the goal for Medicare healthcare over the next 10 years to become a health system that achieves equitable outcomes through high quality, affordable, patient-centered care. It is important to incorporate emerging technologies and big data to help drive technology assessment going forward. So, what are the 3 priorities for CMS going forward? These include growth of accountable care to improve quality, increase savings, and promote innovation to meet patient’s needs, alignment around what really matters, and making sure that there is true equity. Fleisher highlights that the FDA is “responsible for protecting the public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. CMS has the authority to determine whether a particular medical item or service, is reasonable and necessary for the treatment of an illness or injury in the Medicare population. There is a call to action to continue to collect data in order to learn more about the impact of an emerging technology on a given population. When it comes to medical devices, there are different categories depending on the type of device and the level of harm from lowest risk to moderate to highest risk. I also want to highlight one of the important slides from the talk that explained Phased Research Framework and Model Documentation for Evaluation of AI models. This framework is helpful as we think about deploying AI and emerging technologies safely going forward.

Here are the important steps and components:

  • Phase 0 Discovery and Intervention which involves stakeholder interviews and mapping model outcomes to future clinical studies.
  • Phase 1 is Technical Performance and Safety which involves IRB and FDA submission, prototype design and feasibility analysis.
  • Phase 2 is Efficacy and Side effects with components of interface design with stakeholder focus groups, pre-pilot model performance, model implementation evaluation and validation, and business plan evaluation.
  • Phase 3 which is Therapeutic Efficacy with the completion of a prospective study and clinical evaluation.
  • And finally Phase 4 Safety and Effectiveness which includes post-deployment surveillance and maintenance risk, quality monitoring, model maintenance, and taking corrective and preventive action and model documentation.

Let’s move into our first session, moderated by JW Beard, with the focus on “Wearable devices and remote monitoring.” The session kicks off with a talk about the Medical Internet of Things by Anura Fernando. The Medical Internet of things refers to the idea that we can connect old and new things to the internet and then these things are related to healthcare, this then gives us the Medical Internet of Things. This is actually so much more than just things, it includes complex technology with many layers to ensure safe, reliable, secure, and effective communications. Within this Medical Internet of Things, harm and healing need to be carefully balanced to ensure patient safety. Important questions include:

What are the clinical use cases for the application of this technology?

What’s more important to patient safety, speed or accuracy?

From here, Fernando takes us through the simplified example of a software-controlled ventilator to demonstrate the ideas of Safety Science related to medical devices and other healthcare products. The design process is important to go from defining the problem that needs to be solved, planning the device, evaluating the technology, and thinking about security and risks. Going forward, standards will be vital for helping to improve patient safety and security.

The next talk is by Ashish Khanna (Ca-na) on “Acute Care and Wearable Technology” with a focus on the current research on emerging technologies and what is needed for research going forward. He starts off with discussing the challenge of keeping patients safe during the postoperative period and monitoring patients appropriately outside of the operating room and ICU. This may be where wearable technology comes into play. Research has shown that 60% of patients on the postoperative floor have at least one abnormal vital sign prior to a cardiorespiratory arrest and there is an increase in mortality with increasing number of abnormal vital signs. Early intervention may be needed even at the first abnormal vital sign event and monitoring postoperative patients on the ward is an important consideration going forward. What we are doing right now with spot checks is just not enough. A study published in 2019 in Anesthesiology revealed that spot blood pressure checks missed about 50% of episodes of MAP less than 65mmHg in postoperative patients on the floor. Another study, the PRediction of Opioid-induced respiratory Depression on

Inpatient wards using continuous capnoGraphY and Oximetry: An International Prospective, Observational

Trial, or the PRODIGY Study, evaluated patients receiving IV opioids on the general hospital floor and found that half of patients had at least one episode of monitor-detected respiratory depression and without continuous monitoring, these events may have been missed. Going forward, there may be a need for continuous monitoring devices for patients on the hospital floor, but these new devices need to be tested and studied with interventional outcomes studies. Implementation science behind continuous monitoring is important as well. Khanna leaves us with some ideas for the future that include the following next steps:

  • Appropriate trial design examining ‘patient centric outcomes’
  • Rich repository of vital signs data – to develop algorithms to predict patient deterioration early
  • Effective analysis of alarm fatigue with modelling of alarm thresholds and delay periods
  • Development of Postoperative patient safety guidelines
  • Creation of a Patient monitoring consortium

There is a call to action for anesthesiologist professionals to be leaders in the space of postoperative monitoring and use our knowledge and experience to keep patients safe after they leave the operating room.

The next talk is by James Grant, “A HEALTH CARE PAYER’S APPROACH TO VALUE-BASED CARE AND INNOVATION. Grant is the senior vice president and chief medical officer for blue cross blue shield of Michigan. Here is the executive summary and key considerations:

  • Through targeted initiatives and partnerships, Blue Cross Blue Shield of Michigan is a national leader in enhancing value-based care for members, customers and providers.
  • Blue Cross has a strong and growing partnership with the Multicenter Perioperative Outcomes Group (MPOG) through the Anesthesiology Performance Improvement and Reporting Exchange
  • Blue Cross has a robust process for evaluating new medical technologies and reviewing existing medical policies to ensure that members have access to cost-effective and medically appropriate clinical services.

Grant highlights the change away from a fee for service model to a value-based payment model to help address cost and quality.

One of the important initiatives with Blue Cross Blue Shield of Michigan is ASPIRE, or Anesthesiology Performance Improvement and Reporting Exchange, which is a component of MPOG, which is the multicenter Perioperative Outcomes Group. This initiative has the following aims:

  • reducing unexplained variation in practice
  • collaborating with anesthesia providers to define best practices.
  • building quality measures
  • reviewing best practices
  • exchanging ideas for improving patient outcomes

The ASPIRE program has led to the following improvements in patient care:

  • 16% improvement in perioperative glucose management and reduced risk of postoperative infections
  • 4 times increase in patients receiving smoking cessation counseling.
  • 25% reduction in the carbon footprint by more efficient and environmentally friendly use of anesthetic gases in patients undergoing general anesthesia.

How does this company incorporate emerging medical technologies? There is a multi-disciplinary committee that evaluates clinical evidence and assessment reports as well as considerations related to safety and effectiveness, margin of improvement, reproducibility, and quality of evidence. Then, the committee determines if a technology is investigational, not medically necessary, or established and then the technical requirements are set for coding and claims processing, and then finally it is determined if the technology will be a covered benefit and the benefits and reimbursement policies are updated.

Our final talk in this session is “Wearables – Consumer vs Medical Grade/Regulatory Perspective” by Dheerendra Kommala, the Chief Medical Officer for ECRI (Ek-Ree). The ECRI is a leading independent patient safety expert reducing preventable harm and making healthcare more transparent and accessible by testing devices and equipment. The mission of ECRI is similar to APSF, striving to get to zero patient harm.  The talk focuses on wearables including consumer grade and medical grade devices as well as the testing, human factors, and useability. Over the past three years, ECRI has evaluated over 250 devices.

Kommala reminds us that we need to be thinking about the user when it comes to new devices especially with changes in healthcare such as providing care for sicker patients in non-acute settings, placing more of the burden of care on patients with little or no clinical supervision, increasing availability of new and complex devices, and considering health, technology, and numerical literacy levels. Let’s also define a medical grade device as something that is regulated by the FDA which reviews the device for safety and efficacy. Consumer devices do not go through that process and there is no obligation to follow quality standards and no requirement to collect data on adverse events.

When talking about technology and new devices, it is important to consider human factors.

Here are some important questions and considerations:

  1. Who are the users that interact with the new system? Considerations include physical size, strength, and stamina, sensory and cognitive abilities, background and training, work objectives and critical tasks.
  2. Where do the users work? What is their environment like? Considerations include lighting levels, noise levels, and nearby equipment.
  3. What kind of user interface does the system require? Considerations include size and shape of the device, device components, information indicators such as lights and sounds, and packaging and labeling.

Some of the devices that ECRI has tested includes Smart Watches, Baby Vital Signs Monitors, Smartphone-Enabled Devices, and Home Cholesterol Test Kits.

Let’s look at the example of the Baby Vital Signs Monitor Smart Socks. ECRI tested 2 devices from 2 vendors. These are available direct to consumer. Key findings included controversy about the need for or the utility of these devices, poor blood oxygen saturation alarm sensitivity, and poor agreement of blood oxygen saturation readings compared to a medical-grade pulse oximeter. Usability issues included setting up the WIFI connection and the use of the smart socks was complicated for first time users.

We need to think about safety and efficacy for not just medical devices, but also consumer devices because these are being used by patients. Going forward, we need to think about the following:

  • Human factors engineering improves process and workflow by understanding work on medical and consumer grade devices. This means that product development must keep human factors engineering in mind from the very beginning.
  • Usability testing is imperative to assess safety, efficacy, and effectiveness of devices and this highlights the need to test products in the care settings where they are intended to be used.
  • Reporting needs for safety incidents related to consumer-grade devices need to be required to help keep patients safe.

Before we wrap up for today, we are going to hear from Thiele again. I also asked Thiele, “What do you envision for the future with regards to emerging medical technologies?” Let’s take a listen to what he had to say.

[Thiele] “I am excited about the use of AI as a force amplifier in the generation of scientific knowledge. There’s a lot of discussion about using AI to help plan and execute scientific experiments in laboratories, as well as to generate novel hypotheses from scanning literature that no single human could ever consume.

I also think it’s possible that AI can unlock physiologic mysteries that we are incapable of discovering or even understanding. In physics, a group led by Rod Lipson in Columbia has used AI to identify candidate state variables based on video recordings of physical dynamical systems, for instance, pendulums or candle flames.”

[Bechtel] Thank you so much to Thiele for contributing to the show today. We are so excited about continuing to learn more about the intersection between anesthesia patient safety and emerging medical technologies. For more high-yield content from the 2023 APSF Stoelting Conference, we hope that you will head over to the APSF YouTube Channel to watch the livestream. Check out the show notes for more information.

If you have any questions or comments from today’s show, please email us at [email protected]. Please keep in mind that the information in this show is provided for informational purposes only and does not constitute medical or legal advice. We hope that you will visit APSF.org for detailed information and check out the show notes for links to all the topics we discussed today.

Have you joined the conversation on twitter? If so, we would love for you to tag us in a tweet @APSForg using the hashtag, #ASPF podcast, and tell us your favorite session from the Stoelting conference or your favorite patient safety priority, or what you want to hear about on a future show! Thanks for listening and we can’t wait to hear from you!

Until next time, stay vigilant so that no one shall be harmed by anesthesia care.

© 2023, The Anesthesia Patient Safety Foundation