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Peripheral Arterial Disease and Foot Wounds

Vascular Physician

· Past medical history indicators of PAD include: history of smoking, age 65 or greater, diabetes history, CAD or stroke, or history of renal, carotid or mesenteric ischemia. Encourage patient to take an active role in their care and monitor their blood glucose levels and remain compliant with prescribed medications. ·

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Episode 209: Antiracism in Medicine Series – Episode 12 – Our Land is Our Health: Addressing Anti-Indigenous Racism in Medicine

The Clinical Problem Solvers

10:37 “Blood quantum” and the burden of proof 18:05 Challenges of Indigenous Peoples in medical spaces 24:50 COVID-19 and climate change’s impact on Indigenous Peoples 30:27 Racism in academia and creating safe spaces 41:22 “Data genocide” 50:11 What can listeners do going forward?

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Submitting a 510(k)? Keep Hoarding Blank CDs

FDA Law

Lenz, Senior Medical Device Regulation Expert — FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here ) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency. The ability to track changes and provide and respond to comments is an important part of this process.

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Podcast: ECPR

PEMBlog

2005 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. So, eCPR, extracorporeal cardiopulmonary resuscitation, is an advanced medical procedure used in cases of cardiac arrest where traditional CPR has failed. I hope that it provided a basic overview and some context.

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The Good, Bad, and Ugly side of 510(k)s—HP&M’s Early Experience with the eSTAR Template for 510(k)s

FDA Law

Lenz, Principal Medical Device Regulation Expert — Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. There are additionally places to provide attachments for test reports and other supporting documents. When doing so, a pop-up window provides two options.

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FDA Issues a Draft Guidance for Content of Premarket Submissions for Device Software Functions

FDA Law

Over the past 16 years, there have been numerous advances in healthcare technology, particularly with respect to the use of software in and as a medical device. Summaries of the impact of the 21st Century Cures Acts on software and the definition of a medical device are available here, here, here, and here. corrections and removals).

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Episode 213: Antiracism in Medicine Series – Episode 13 – Centering Asian Americans: Racism, Violence, and Health

The Clinical Problem Solvers

provision in only English +/- Spanish), limitations of medical technology (i.e., Remember that more deeply understanding your patients can provide meaning! Insufficient language services (i.e., Seeking to more deeply understand your patients is not an additional burden: ultimately, it is an additional benefit. The Model Minority Myth.”