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		<title>The Medical Device That May Lead to Harm in People of Color</title>
		<link>https://medika.life/the-medical-device-that-may-lead-to-harm-in-people-of-color/</link>
		
		<dc:creator><![CDATA[Pat Farrell PhD]]></dc:creator>
		<pubDate>Tue, 13 Dec 2022 14:51:01 +0000</pubDate>
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					<description><![CDATA[<p>Testing medical equipment is aimed at ensuring that it applies to every patient, regardless of their race, but one piece missed the mark.</p>
<p>The post <a href="https://medika.life/the-medical-device-that-may-lead-to-harm-in-people-of-color/">The Medical Device That May Lead to Harm in People of Color</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
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<p id="278b">Several biological indicators used to assess our physical health have come into question;&nbsp;<a href="https://www.mdanderson.org/publications/focused-on-health/5-questions-about-bmi.h15-1592991.html" rel="noreferrer noopener" target="_blank">BMI</a>,&nbsp;<a href="https://www.medpagetoday.com/primarycare/preventivecare/102113?xid=nl_mpt_DHE_2022-12-10&amp;eun=g444003d0r&amp;utm_source=Sailthru&amp;utm_medium=email&amp;utm_campaign=Weekly%20Review%202022-12-10&amp;utm_term=NL_DHE_Weekly_Active" rel="noreferrer noopener" target="_blank">BP</a>,&nbsp;<a href="https://health.clevelandclinic.org/body-temperature-what-is-and-isnt-normal/" rel="noreferrer noopener" target="_blank">temperature</a>, and&nbsp;<a href="https://www.healthline.com/health/normal-blood-oxygen-level" rel="noreferrer noopener" target="_blank">oxygen readings</a>. All of them may need revamping or a rethinking of ranges rather than rigid numbers, but we question one because of the device used to measure it.</p>



<p id="782b">Racial bias prevents many people from&nbsp;<a href="https://www.brookings.edu/articles/unequal-opportunity-race-and-education/" rel="noreferrer noopener" target="_blank">attending adequate schools</a>, entering promising careers, and accessing&nbsp;<a href="https://www.ncbi.nlm.nih.gov/books/NBK568721/" rel="noreferrer noopener" target="_blank">adequate healthcare</a>. This bias also affects where they can&nbsp;<a href="https://www.wise-geek.com/what-is-housing-bias.htm" rel="noreferrer noopener" target="_blank">find suitable housing</a>, and that&nbsp;<a href="https://pubmed.ncbi.nlm.nih.gov/18080206/" rel="noreferrer noopener" target="_blank">housing may contribute to health difficulties</a>&nbsp;brought on by pollution or vermin infestation. The situation, undeniably, is untenable, and anyone who believes in human rights will find each of these impediments anathema.</p>



<p id="f376">All the above is clear, but taking the situation two steps further will reveal the hidden extent of the potential damage raining down on anyone who is a victim of this bias. And, most disturbing, this further damage to health happens in the medical realm.</p>



<p id="2433"><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6352250/" rel="noreferrer noopener" target="_blank">Socioeconomic factors</a>&nbsp;lead to health risks such as asthma, and the need for ongoing, accurate treatment for asthma is mostly with inhalers. The condition is so severe that frequent emergency treatment is sought.&nbsp;<a href="https://www.medicalnewstoday.com/articles/asthma-in-african-americans#risk-factors" rel="noreferrer noopener" target="_blank"><em>Compared with white people</em></a><em>&nbsp;with asthma, African American people with asthma are&nbsp;</em><a href="https://www.aafa.org/wp-content/uploads/2022/08/asthma-disparities-in-america-burden-on-racial-ethnic-minorities.pdf" rel="noreferrer noopener" target="_blank"><em>five times</em></a><em>&nbsp;more likely to visit the emergency room for symptoms.</em></p>



<p id="cfc9">One of the inhalers of choice for asthma is&nbsp;<a href="https://medlineplus.gov/druginfo/meds/a682145.html" rel="noreferrer noopener" target="_blank">albuterol</a>, and here, again, there is a problem with treatment. A study of over 1,400 children revealed a&nbsp;<a href="https://www.atsjournals.org/doi/10.1164/rccm.201712-2529OC" rel="noreferrer noopener" target="_blank">genetic lack of appropriate response</a>&nbsp;to this drug in some patients. And problems in sampling were apparent.&nbsp;<em>We and others have documented the implications and challenges posed by the lack of non-European study populations in&nbsp;</em><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4679830/" rel="noreferrer noopener" target="_blank"><em>biomedical research</em></a><em>.&nbsp;</em>Sampling bias is at the heart of one major problem in device engineering.</p>



<p id="ddcd">Once asthma treatment is sought, there still needs to be a resolution to the underlying measurement problem. While in the ER, how is the oxygen level of these patients determined? The usual initial route is to get a quick level using an oximeter slipped on a finger. It’s a rapid and supposedly accurate measure of how much oxygen the patient has in their blood; vital information.</p>



<p id="2e0f">Who questions the oximeter readings? The assumption is that the task is accurate because the device is FDA approved, made by a reputable company, and has been used for years in hospitals. But that conclusion is patently false.</p>



<p id="7b9f">The validity of the readings was made&nbsp;<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4803087/" rel="noreferrer noopener" target="_blank">primarily on persons of European descent.&nbsp;</a>How accurate would they be on anyone who did not meet that criterion? The answer would seem obvious.</p>



<p id="708f"><a href="https://www.statnews.com/2022/11/01/pulse-oximeters-inaccuracies-fda-scrutiny/" rel="noreferrer noopener" target="_blank"><em>Studies dating back to 2005</em></a><em>&nbsp;show pulse oximeters tend to overestimate the amount of oxygen a patient with darker skin may actually have in their blood. It’s simple physics: Melanin in skin absorbs some of the light the devices analyze to make their readings. The darker the skin, the more melanin there is, and the less light passes through.</em></p>



<p id="9035">If the readings are wrong, how does that have an impact on treatment? Again, no question that there is a bias in oxygen levels leading to changes in medical care.</p>



<p id="e14a">The&nbsp;<a href="https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication" rel="noreferrer noopener" target="_blank">FDA issued an alert on oximeters</a>, but did everyone dispose of their older, inaccurate devices in healthcare and the home? Other factors affect these readings, including&nbsp;<em>poor circulation, skin pigmentation, skin thickness, skin temperature, current tobacco use, and use of fingernail polish.</em></p>



<p id="5fb9"><a href="https://www.hpl.hp.com/hpjournal/pdfs/IssuePDFs/1976-10.pdf?source=aw&amp;subacctid=78888&amp;subacctname=Skimlinks&amp;adcampaigngroup=561219jumpid=af_gen_nc_ns&amp;utm_medium=af&amp;utm_source=aw&amp;utm_campaign=Skimlinks&amp;campaignID=&amp;utm_content=78888_Skimlinks_&amp;awc=7168_1666793137_ec246ccc86e609f77284ce2fe3373c90" rel="noreferrer noopener" target="_blank">NASA had developed guidelines</a>&nbsp;and devices for more accurately measuring blood oxygen, but the corporation involved in it changed its marketing direction and the device was dropped.</p>



<p id="22db">We know that the disturbing use of&nbsp;<a href="https://link.springer.com/article/10.1007/BF00858362" rel="noreferrer noopener" target="_blank">oximeters tested in Japan</a>&nbsp;(with a relatively homogenous population) may lead to delays in treatment in persons with darker skin. How is this permissible? It’s not, and the NASA devices should be considered again.</p>
<p>The post <a href="https://medika.life/the-medical-device-that-may-lead-to-harm-in-people-of-color/">The Medical Device That May Lead to Harm in People of Color</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
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		<title>Four Ways COVID has Changed Health Tech</title>
		<link>https://medika.life/four-ways-covid-has-changed-health-tech/</link>
		
		<dc:creator><![CDATA[John Whyte MD]]></dc:creator>
		<pubDate>Thu, 30 Dec 2021 00:16:09 +0000</pubDate>
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		<guid isPermaLink="false">https://medika.life/?p=13549</guid>

					<description><![CDATA[<p>Like most tech lovers, I’m excited about the upcoming CES conference.&#160; I won’t be attending in person but will be watching it very closely from a virtual platform. As a physician, I am particularly interested in health tech and how it can improve patient outcomes – both individual patients as well as populations of patients. [&#8230;]</p>
<p>The post <a href="https://medika.life/four-ways-covid-has-changed-health-tech/">Four Ways COVID has Changed Health Tech</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
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<p>Like most tech lovers, I’m excited about the upcoming CES conference.&nbsp; I won’t be attending in person but will be watching it very closely from a virtual platform. As a physician, I am particularly interested in health tech and how it can improve patient outcomes – both individual patients as well as populations of patients. &nbsp;But my assessment of tech this year will be very different than previous years.&nbsp;</p>



<p>&nbsp;How so?</p>



<p>The COVID pandemic has changed the way we evaluate health technologies in four important and distinct ways.</p>



<ol class="wp-block-list" type="1"><li><strong>Practicality replaces glitz.</strong>&nbsp; The “Wow factor” is what mattered in the past.&nbsp; “Look how cool this laser is that can identify your heart rhythm from 300 feet away!” “This headset lets me see how food travels through my body in real time!”&nbsp; &nbsp;Technology can still be cool, but now the question is how will I use it?&nbsp; Wearables that measure important variables like blood pressure will get more attention than new imaging tools that simply provide a clearer picture.</li><li><strong>Prevention takes precedence over therapeutics.</strong>&nbsp; COVID has demonstrated to us the importance of our personal health.&nbsp; For too long, we made our jobs and other commitments our top priority.&nbsp; Going forward, one’s personal health will become a major focus, especially as it relates to prevention.&nbsp; How will a particular technology let me take control of my own health? &nbsp;Nowadays, I am now more interested in a toilet that can monitor my urine for signs of diabetes or my stool for colorectal cancer than a device that creates holograms.&nbsp; Once one gets pass the “icky” factor of some tools,&nbsp; we will evolve to truly personalized preventive medicine.</li><li><strong>Rigorous outcomes rule the day.</strong>&nbsp; Everything now will be measured by how did it change patient outcomes.&nbsp; Sure, it a device might show a new way to measure blood glucose – but what impact does it have on quality of life, co-morbidities, and life expectancy?</li><li><strong>Consumer centricity rather than physician centricity.</strong>&nbsp; In the past, technology has been focused on the health system and doctors.&nbsp; It’s been a B-B approach.&nbsp; That won’t go away, but more and more tech innovations will put the health consumer in charge.&nbsp; For instance, I won’t be wearing a device that sends all the information to my doctor, but rather there will be more interpretation of all the data from wearables with direct communication to the patient.&nbsp; This may require changes in regulation by the US Food and Drug Administration with a more practical definition of what constitutes a “medical device.”&nbsp;</li></ol>



<p>The real future of &nbsp;digital health is when tech tools&nbsp; continuously collect health data points and help interpret the information and provide preliminary diagnoses to patients.&nbsp;&nbsp; The doctor isn’t going to be left out of this equation, but the difference will be that the patient will no longer be left out.&nbsp; It’s the patient who will be at the center of how these technologies function from start to finish.</p>



<p>I’m sure I still going to be wow-ed this year and be entertained by the advancements we have made, especially during the last two years. But I’m also going to ask tougher questions on innovation, especially as relates to the purpose and impact.</p>
<p>The post <a href="https://medika.life/four-ways-covid-has-changed-health-tech/">Four Ways COVID has Changed Health Tech</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
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