Practice Device Classifications
- Miss America in 1995, and a board member of the Helen Keller Foundation for Research and Education
- a competitive bodybuilder and the star of television’s “The Incredible Hulk”
- the founder of Apple Computers
- the star of the 1980’s sitcom “Different Strokes”
- an actor in the 1987 film “The Princess Bride” who said, “Hello. My name is Inigo Montoya. You killed my father. Prepare to die.”
- European Commission Regulatory Framework
- Medical Device Regulation
- In Vitro Device Regulation
- EU Unique Device Identifier
- FDA Unique Device Identifier
- Oriel STAT-A-MATRIX
- Oriel’s downloadable .pdf of the MDR, with links in a table of contents
- My blog
CONSULTING & TRAINING
Oriel STAT-A-MATRIX(an International company; I consult with Oriel)Qunique (based in Switzerland)Me(Jason 🙂
This is my opinion.
As a society we’re learning that healthcare should improve. You can help.
For example, consider the spine implants and cardiovascular implants of the celebrities shown. They have access to the any healthcare money can buy, yet are still subject to the same risks as billions of people on the planet who hope our healthcare companies and providers are informed and ethical.
But, spine implant companies are often the subject of lawsuits and federal investigations for conflicts of interests when doctors advise patients but are paid by medical device companies that receive revenue from the procedures.
Similarly, For example, Cardiovascular stents are implanted in millions of people each year, including David Letterman, Bill Clinton, and George Bush, but have been criticized as often being an unnecessary procedure, even for the president, and by the president’s surgeon who implanted the stent.
This is a problem globally. 400,000 people received toxic implants from Europe, and in the United States 80,000 – 240,000 people die from healthcare errors each year, and globally 5 million people die each year from low-quality healthcare. The MDR is a step towards data-driven decisions in healthcare that’s less influenced by marketing and false views. Learn more in my MDR blogs about reducing risk as far as possible.
As professionals, we can help society by understanding regulations like the MDR that intended to protect people, practicing leadership skills that let us influence our organizations, and letting our elected officials know that healthcare safety and cost-effectiveness is important to us.
Thank you for reading.
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