Category: fda

Toxic Gas That Sterilizes Medical Devices Prompts Safety Rule Update

The Environmental Protection Agency is tightening regulation of ethylene oxide, a carcinogenic gas used to sterilize medical devices. The agency is trying to balance the interests of the health care industry supply chain with those of communities where the gas creates airborne health risks.

‘Behind the Times’: Washington Tries to Catch Up With AI’s Use in Health Care

Lawmakers and regulators are trying to understand how AI is changing health care and how it should be regulated. The industry fears overreach.

FDA’s Plan to Ban Hair Relaxer Chemical Called Too Little, Too Late

The FDA’s recent notice that it would move to ban formaldehyde in hair-straightening products comes more than a decade after researchers raised alarms about health risks. Scientists say a ban would still leave many dangerous chemicals in hair straighteners.

Ketamine Therapy for Mental Health a ‘Wild West’ for Doctors and Patients

Ketamine, approved by the FDA as an anesthetic in 1970, is emerging as a major alternative mental health treatment, and there are now more than 500 ketamine clinics around the country. But with little regulation and widely varying treatment protocols, it’s a medical “wild West.”

Patients With Narcolepsy Face a Dual Nightmare of Medication Shortages and Stigma

It’s been more than a year since the FDA declared a national shortage of Adderall, and it’s affecting more than just patients with ADHD. Those with narcolepsy, a much rarer condition, are often treated with the same medication. Without it, they’re often unable to drive or function as usual.

‘AGGA’ Inventor Testifies His Dental Device Was Not Meant for TMJ or Sleep Apnea

The FDA and Department of Justice are investigating the Anterior Growth Guidance Appliance, or “AGGA.” TMJ and sleep apnea patients have filed lawsuits alleging the device harmed them. Its inventor now says the AGGA was never meant for these ailments.

‘AGGA’ Inventor Testifies His Dental Device Was Not Meant for TMJ or Sleep Apnea

The FDA and Department of Justice are investigating the Anterior Growth Guidance Appliance, or “AGGA.” TMJ and sleep apnea patients have filed lawsuits alleging the device harmed them. Its inventor now says the AGGA was never meant for these ailments.

Deep Flaws in FDA Oversight of Medical Devices, and Patient Harm, Exposed in Lawsuits and Records

Thousands of medical devices are sold, and even implanted, with no safety tests.

Patients Facing Death Are Opting for a Lifesaving Heart Device — But at What Risk?

The HeartMate 3 is considered the safest mechanical heart pump of its kind, but a federal database contains more than 4,500 reports in which the medical device may have caused or contributed to a patient’s death.

KFF Health News’ ‘What the Health?’: Democrats See Opportunity in GOP Threats to Repeal Health Law 

Sensing that Republicans are walking into a political minefield by threatening once again to repeal the Affordable Care Act, the Biden administration is looking to capitalize by rolling out a series of initiatives aimed at high drug prices and other consequences of “corporate greed in health care.” Meanwhile, the Supreme Court hears a case that could determine when and how much victims of the opioid crisis can collect from Purdue Pharma, the drug company that lied about how addictive its drug, OxyContin, really was. Alice Miranda Ollstein of Politico, Anna Edney of Bloomberg News, and Rachana Pradhan of KFF Health News join KFF Health News chief Washington correspondent Julie Rovner to discuss these issues and more. Also this week, Rovner interviews Dan Weissmann of KFF Health News’ sister podcast, “An Arm and a Leg,” about his investigation into hospitals suing their patients over unpaid bills.