Medtronic: Technology Bias Is Real. Here’s What We’re Doing To Fix It
Medtronic is addressing technology bias in pulse oximeters, which may not accurately measure oxygen levels across all skin tones. The company has taken steps to improve device accuracy, including:
1. Participating in an FDA panel on pulse oximeter accuracy
2. Opening a physiology lab in a diverse Denver neighborhood for inclusive clinical trials
3. Conducting its own clinical trials to innovate quickly
Medtronic's Nellcor pulse oximeter missed 7.9% of hypoxemic events in a recent study, compared to 30% for a competitor's device. The company aims to reduce this to zero, regardless of skin type or perfusion. The new lab has enrolled over 130 diverse participants, focusing on equity in healthcare technology.
Medtronic sta affrontando il pregiudizio tecnologico negli ossimetri, che potrebbero non misurare accuratamente i livelli di ossigeno su tutti i tipi di pelle. L'azienda ha intrapreso diverse iniziative per migliorare l'accuratezza dei dispositivi, tra cui:
1. Partecipazione a un panel della FDA sull'accuratezza degli ossimetri
2. Apertura di un laboratorio di fisiologia in un quartiere diversificato di Denver per trial clinici inclusivi
3. Svolgimento di trial clinici propri per innovare rapidamente
L'ossimetro Nellcor di Medtronic ha mancato il 7,9% degli eventi ipossiemici in uno studio recente, rispetto al 30% di un dispositivo concorrente. L'azienda punta a ridurre questo a zero, indipendentemente dal tipo di pelle o perfusione. Il nuovo laboratorio ha arruolato più di 130 partecipanti diversificati, concentrandosi sull'equità nella tecnologia sanitaria.
Medtronic está abordando el sesgo tecnológico en los oxímetros de pulso, que pueden no medir con precisión los niveles de oxígeno en todos los tonos de piel. La compañía ha tomado medidas para mejorar la precisión del dispositivo, que incluyen:
1. Participación en un panel de la FDA sobre la precisión de los oxímetros de pulso
2. Apertura de un laboratorio de fisiología en un vecindario diverso de Denver para ensayos clínicos inclusivos
3. Realización de ensayos clínicos propios para innovar rápidamente
El oxímetro Nellcor de Medtronic perdió el 7.9% de los eventos hipoxémicos en un estudio reciente, en comparación con el 30% de un dispositivo competidor. La empresa tiene como objetivo reducir esto a cero, independientemente del tipo de piel o perfusión. El nuevo laboratorio ha inscrito a más de 130 participantes diversos, centrándose en la equidad en la tecnología de atención médica.
메드트로닉은 기술 편향 문제를 해결하고 있으며, 이는 모든 피부 색조에서 산소 수준을 정확하게 측정하지 못할 수 있습니다. 회사는 장치의 정확성을 개선하기 위해 다음과 같은 조치를 취했습니다:
1. 산소 측정기 정확성에 관한 FDA 패널 참여
2. 포괄적인 임상 시험을 위한 다양한 덴버 지역의 생리학 실험실 개설
3. 빠른 혁신을 위한 자체 임상 시험 수행
메드트로닉의 넬콜 산소 측정기는 최근 연구에서 7.9%의 저산소증 이벤트를 놓친 반면, 경쟁사의 경우는 30%에 달했습니다. 회사는 피부 유형이나 관류에 관계없이 이를 제로로 줄이겠다는 목표를 가지고 있습니다. 새 실험실에는 130명 이상의 다양한 참가자가 등록되었으며, 의료 기술의 공정성에 초점을 맞추고 있습니다.
Medtronic s'attaque au biais technologique dans les oxymètres de pouls, qui peuvent ne pas mesurer avec précision les niveaux d'oxygène sur tous les tons de peau. L'entreprise a pris des mesures pour améliorer la précision des dispositifs, notamment :
1. Participation à un panel de la FDA sur la précision des oxymètres de pouls
2. Ouverture d'un laboratoire de physiologie dans un quartier diversifié de Denver pour des essais cliniques inclusifs
3. Réalisation d'essais cliniques internes pour innover rapidement
L'oxymètre Nellcor de Medtronic a manqué 7,9 % des événements hypoxémiques lors d'une étude récente, contre 30 % pour un dispositif concurrent. L'entreprise vise à réduire cela à zéro, quel que soit le type de peau ou la perfusion. Le nouveau laboratoire a inscrit plus de 130 participants diversifiés, se concentrant sur l'équité dans la technologie de la santé.
Medtronic beschäftigt sich mit technologischen Vorurteilen bei Pulsoximetern, die möglicherweise die Sauerstoffwerte bei allen Hauttönen nicht genau messen. Das Unternehmen hat Schritte unternommen, um die Genauigkeit der Geräte zu verbessern, darunter:
1. Teilnahme an einem FDA-Panel zur Genauigkeit von Pulsoximetern
2. Eröffnung eines Physiologielabors in einem vielfältigen Stadtviertel von Denver für inklusive klinische Studien
3. Durchführung eigener klinischer Studien, um schnell zu innovieren
Das Nellcor-Pulsoximeter von Medtronic hat in einer aktuellen Studie 7,9% der hypoxämischen Ereignisse verpasst, im Vergleich zu 30% bei einem Konkurrenzgerät. Das Unternehmen strebt an, dies auf null zu reduzieren, unabhängig von Hauttyp oder Perfusion. Das neue Labor hat über 130 diverse Teilnehmer eingeschrieben und konzentriert sich auf Gerechtigkeit in der Gesundheitstechnologie.
- Medtronic is actively addressing technology bias in pulse oximeters
- Nellcor pulse oximeter outperformed competitor devices in recent study, missing only 7.9% of hypoxemic events compared to 30%
- New physiology lab opened in diverse neighborhood to ensure inclusive clinical trial enrollment
- Over 130 diverse participants enrolled in ongoing clinical trials
- Nellcor pulse oximeter still missed 7.9% of hypoxemic events in recent study
- Potential regulatory changes or increased scrutiny on pulse oximeter accuracy could impact Medtronic's business
NORTHAMPTON, MA / ACCESSWIRE / August 5, 2024 / Medtronic
Medtronic has taken measurable steps to drive change.
Doctors have used pulse oximeters for more than 40 years, but the pandemic put the devices in the spotlight after studies found they may not be accurate across all skin tones.
"What we saw during the pandemic was health disparities," said Bradley, who works in sales in the Acute Care & Monitoring (ACM) business at Medtronic. "We recognize that patients of color were not faring as well as their lighter skin counterparts."
In her presentations, Bradley, the mother of a multiracial daughter, elaborates on why the devices can sometimes fall short. She calls it "technology bias."
There's a lot we still don't understand about what drives that bias, but we know low perfusion, or the flow of blood to cells and tissues, along with skin pigmentation, and user error, are at the core.1
While our pulse oximeter, Nellcor™, has delivered monitoring solutions for decades, Medtronic can do better, ACM President Frank Chan said. It's why the company has taken measurable steps to drive change, such as participating in a U.S. Food and Drug Administration panel on the accuracy of pulse oximeters and opening a physiology lab in a racially diverse neighborhood to ensure inclusive clinical trial enrollment and participation.
"We saw all the studies coming out of the pandemic around equity and pulse oximetry and delivering safe care," said Chief Medical Officer for ACM Dr. Sam Ajizian. "We accelerated our work. In doing so, we aim to do the right thing for the patient."
What is a pulse oximeter?
Dr. Ajizian was a young physician when pulse oximeters were first introduced to the marketplace. They were a "transformative" tool that removed the guesswork in measuring the amount of oxygen in a patient's blood - and alerting doctors when more may be needed.
If you've had surgery, ridden in an ambulance, or even visited a clinic, chances are a pulse oximeter has been clipped to the end of your finger.
"It's kind of magical to be able to take something on the outside of the body and use it to measure how much oxygen is going to the tissue that's contained in the blood on the inside of the body," Dr. Ajizian said.
While pulse oximeters are essential to patient safety, not all are created equal. In a recent study enrolling healthy volunteers to measure the effects of skin pigmentation and perfusion index on pulse oximeter accuracy, one of the company's competitor's devices, for example, missed
"The goal isn't to be better than everyone else," Case said. "The goal is to provide a solution that works for everybody. How do we get that
Walking the walk
The commitment to getting it right - every time - is why the company opened a clinical physiology lab near the Five Points neighborhood of Denver, Colorado. It's a racially diverse area where community members can easily access the unassuming lab, which is embedded within a larger medical complex. Many trial participants walk to the lab from their homes.
"We decided to locate this lab in Denver, away from the central offices of Medtronic, and it has proven to be the right choice," said Lab Manager Roger Martin-Pressman. "To make it convenient for people from diverse backgrounds to access these research opportunities was really important to me."
The lab empowers the company to conduct its own clinical trials, meaning it can test devices with more speed and frequency and, in turn, innovate quickly. "We really want devices to get better based on the data we collect here," Martin-Pressman said. "And not just better so clinicians understand how to use them, but also better so that people who wear them have better outcomes."
The larger, more diverse data set being collected at the lab is critical to research and development work at Medtronic, Case said. It ensures we're approaching our work with equity before it leaves the innovation lab.
Building trust
Obioma Nwankwo is a clinical studies coordinator for the clinical physiology lab in Denver. She recruits trial participants and often leads engagement events in the community, such as hosting booths at the city's Juneteenth festival, to build trust within the community and educate about the trials and our commitment to health equity.
"Sometimes the end goal is not always getting someone in the chair and having them come and do the study," Obioma said. "Sometimes the end goal is just spreading awareness, or having a conversation."
But the community is responding; trial enrollment continues to tick upward. The lab has already enrolled more than 130 participants and will continuously recruit. The opportunity to be part of a clinical trial that could improve device accuracy across all skin pigmentations was a driving factor for Zahra Abdullahi to enroll.
"As a minority in the healthcare system, a lot of things are overlooked," said Abdullahi, a college student studying engineering. "I'm doing this not only for my safety, but for others' as well. I have siblings and friends who are also minorities and making sure they have accurate representation in healthcare is very important."
Lasting change
When Bradley first began her career in 1991, working as a respiratory therapist for neonatal and pediatric patients, she would have argued there weren't health disparities in her work.
"When I look retrospectively on it, I recognize that's not true, there probably always were some biases," she said, adding anyone who wants to be "intellectually honest" would agree there are disparities in the access and provision of healthcare.
Even though the Medtronic pulse oximetry device meets all current FDA standards, those questions about health equity are spurring broader change, and Medtronic is making meaningful contributions.
"I'm proud that Medtronic has taken a stance to say that's not good enough," Bradley said.
Not to mention, it's just the right thing to do, said Martin-Pressman, the lab manager.
"Equality is giving everybody the same opportunity, but equity is ensuring the outcome is the same," he said.
Ronda Bradley, left, with her family.
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SOURCE: Medtronic
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