Medical Device Problems @deviceproblems

Educating about the dangers of certain medical devices & the device approval process. Originally the account for The Bleeding Edge documentary. medicaldeviceproblems.com USA Joined September 2017

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STAT @statnews

2 years ago

Medicare has different standards than the FDA. That’s how it should be. trib.al/12Fab3k

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Medical Device Problems @deviceproblems

3 years ago

The troubles with 510(k)-cleared Profemur hip implants continue. This is a prime example of why 510(k) clearance should be a LIMITED EXCEPTION, not a rule for implantable devices! @US_FDA @FDADeviceInfo kffhealthnews.org/news/article/p…

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Medical Device Problems @deviceproblems

3 years ago

What fresh hell is this, asking patients TO MONITOR A #MEDICALDEVICE THEY USE WHILE SLEEPING for overheating/fire?! Add a smoke detector on your CPAP machine, I guess? Why do we have an #FDA? This is embarrassing, y'all. #DoTheRightThing?

U.S. FDA @US_FDA

3 years ago

Today, as part of our continued commitment to protect and promote the public health, we’re alerting patients and healthcare providers of an emerging safety issue involving Philips Respironics’ DreamStation 2 CPAP machines. fda.gov/news-events/pr…

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Medical Device Problems @deviceproblems

3 years ago

More modifications to high risk devices = more recalls of those devices. Who would've guessed THAT? 🙄 ~10% of U.S. residents will have #medicaldevices implanted during their lifetime, and physicians should be aware of this association! #patientsafety medpagetoday.com/publichealthpo…

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Medical Device Problems @deviceproblems

3 years ago

AdvaMed spent 4 yrs lobbying against restrictions on ethylene oxide, stating it's "too hard" to find alternatives. So the industry you defend as masters of rapid innovation CAN'T innovate when it comes to safety, only when it comes to profits? Uh-uh... #FAIL #medicaldevices #FDA

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Medical Device Problems @deviceproblems

3 years ago

EPA proposes limits to a carcinogen used to sterilize #medicaldevices while FDA encourages alternatives. Meanwhile, @AdvaMedUpdate CEO Scott Whitaker INSISTS many medical devices “simply cannot” be sterilized by another method. statnews.com/2023/04/11/eth…

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Medical Device Problems @deviceproblems

3 years ago

Did you know companies aren't required to provide a full list of the materials in their #medicaldevices? We think this is wrong! If you have new-onset problems after being implanted w/ a device, consider LTT testing like @MELISA_test for these metals & alloys.

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Medical Device Problems @deviceproblems

3 years ago

The #FDA stated on Thursday that several Exactech joint replacement #medicaldevices were packaged in defective bags. Patients are recommended to contact their healthcare providers about any pain, swelling, weakness, grinding, noise, etc. #patientsafety medpagetoday.com/orthopedics/or…

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Medical Device Problems @deviceproblems

3 years ago

Thanks to @WRAL for this segment on the struggles for women who need to have recalled #breastimplants removed, but why no mention of the recent @US_FDA statement regarding the risks of OTHER types of cancers due to these #medicaldevices? @AbbVie wral.com/women-struggle…

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Medical Device Problems @deviceproblems

3 years ago

5 years ago

Recall Notice 🚨 Armstrong Medical Limited Recalls AMSORB PLUS PREFILLED G-CAN 1.0L Due to Reduced Gas Flow to Patients During Anesthesia fda.gov/medical-device…