@deviceproblems profile picture
Medical Device Problems @deviceproblems

Educating about the dangers of certain medical devices & the device approval process. Originally the account for The Bleeding Edge documentary.

Joined September 2017
  • Tweets 1,650
  • Following 1,800
  • Followers 2,549
167 Photos and videos
Pinned Tweet
Medical Device Problems@deviceproblems
14 Jan 2019
To continue the fight for #PatientsOverProfits, we are handing the reins of @bleedingedgedoc social media accounts to the activists behind Medical Device Problems. See the image for a message from The Bleeding Edge filmmakers.
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Medical Device Problems retweeted
STAT
@statnews
2 Feb 2024
Medicare has different standards than the FDA. That’s how it should be. trib.al/12Fab3k

Medicare has different standards than the FDA. That’s how it should be

Medicare has different standards than the FDA. That’s how it should be.

statnews.com
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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/artic…

Patients Expected Profemur Artificial Hips to Last. Then They Snapped in Half. - KFF Health News

The FDA and the manufacturer were alerted to Profemur titanium hips breaking inside U.S. patients as of 2005. It took 15 years to recall the devices. Many fractures could have been avoided.

kffhealthnews.org
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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
28 Nov 2023
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/press-an…
A textured blue background with white text: "FDA cautions public of safety issue with Philips’ DreamStation 2 CPAP machines"

ALT A textured blue background with white text: "FDA cautions public of safety issue with Philips’ DreamStation 2 CPAP machines"
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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/publichealt…

Do All Those Postmarket Device Modifications Add Up to Patient Harm?

Cardiovascular devices lead the pack in having multiple iterations culminate in device recall

medpagetoday.com
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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/ethy…

EPA proposes limits on carcinogenic gas used to sterilize medical devices

The EPA has proposed new limits on the use of a carcinogenic gas called ethylene oxide, which the Biden administration said is part of its Cancer Moonshot.

statnews.com
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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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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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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…

FDA: Watch for Joint Replacement Device Failure After Exactech Recall

Revision surgery only recommended for patients with pain

medpagetoday.com
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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-to-g…

Women struggle to get potentially cancer-causing breast implants removed, four years after recall

Since manufacturer Allergan recalled textured implants in 2019 due to a link to cancer, thousands of women with the implants have been grappling with what to do.

wral.com
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Ah, yes, good ol' @Medtronic, up to their usual #DirtyDeeds with complicit doctors to perform unnecessary procedures so they can sell #medicaldevices that cost $15,000 each and experiment on unwitting low-income minority patient populations. #PatientSafey latimes.com/business/story/2…

She didn't need the risky surgery. County doctors talked her into it anyway, lawsuit says

An L.A. County public hospital performed an unneeded surgery after its doctors received pay from the maker of the medical device they implanted, a whistleblower says.

latimes.com
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Medical Device Problems retweeted
Amanda Dykeman@manda1219
9 Feb 2023
For those of you that have received an implanted medical device, did you receive an implant card which listed your device’s unique device identifier? The UDI acts almost like the VIN on your vehicle and is used to relay important recall information.
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5 votes • Final results
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Urgent Voluntary Recall: 🚨 On January 5, 2022, CorneaGen discovered that Cornea Patch Grafts were obtained from a donor who tested reactive for HIV-1/HIV-2 Plus O antibody and were shipped prior to being medically cleared. fda.gov/vaccines-blood-biolo…

Urgent Voluntary Recall: CorneaGen Cornea/Cornea Patch Grafts

On January 5, 2022, CorneaGen discovered that Cornea Patch Grafts were obtained from a donor who tested reactive for HIV-1/HIV-2 Plus O antibody and were shipped prior to being medically cleared.

fda.gov
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fda.gov/medical-devices/lett…
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Recall Notice 🚨 Arrow International, LLC (Subsidiary of Teleflex Inc.) Recalls the Arrow-Trerotola Percutaneous Thrombolytic Device Due to Risk of Tip Damage During Use fda.gov/medical-devices/medi…
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Leadless Pacing Systems: Risk of Major Complications Related to Cardiac Perforation During Implantation - Letter to Health Care Providers fda.gov/medical-devices/lett…
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Recall Notice 🚨 DeRoyal Industries, Inc. Recalls Procedure Packs Containing Smiths Medical NORMOFLO Irrigation Warming Set Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers fda.gov/medical-devices/medi…
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Recall Notice 🚨 Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing fda.gov/medical-devices/medi…
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Recall Notice 🚨 Magellan Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low Results fda.gov/medical-devices/medi…
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Left Atrial Appendage Occlusion (LAAO) Devices Potentially Associated with Procedural Outcome Differences Between Women and Men (Watchman Device) – Letter to Health Care Providers fda.gov/medical-devices/lett…
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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-devices/medi…
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