20:00 [ICIJ] (E)
A global investigation reveals the rising human toll of lax controls and testing standards pushed by a booming industry. From Amsterdam, Seoul, Lima and Mumbai, to the small American town of Hiawassee, Georgia, medical implants sicken, maim and sometimes kill the very people they were designed to help. Health authorities across the globe have failed to protect millions of patients from poorly tested implants that can puncture organs, deliver errant shocks to the heart, rot bones and poison blood, spew overdoses of opioids and cause other needless harm, a year-long investigation by the International Consortium of Investigative Journalists found.
19:59 [ICIJ] (E)
German and Irish health ministers are leading calls for key elements of new European safety laws on medical devices to be effectively postponed, arguing that a lack of readiness among regulators risks creating shortages of vital implants and surgical equipment. Legislation on the licensing and monitoring of medical devices was passed in 2017 and is due to come into effect in May next year. But many health ministers now believe that Europe’s complex, part-privatized regulatory regime — which they were unwilling to scrap — has failed to prepare itself for the new set of rules.
19:59 [ICIJ] (E)
Patients who suffered debilitating immune reactions after being implanted with metal-containing devices have joined doctors, scientists and industry representatives to testify before a United States government advisory panel probing the risks of immunological responses to metals placed inside the body.
15:41 [U.S. Department of Justice] (E)
The United States has filed a complaint against Sioux Falls, South Dakota, neurosurgeon Wilson Asfora M.D., Medical Designs LLC, and Sicage LLC alleging False Claims Act violations arising from the alleged payment of kickbacks to Asfora tied to the devices he used in spinal surgeries, the Justice Department announced today. Medical Designs and Sicage are medical device distributorships in South Dakota owned and operated by Asfora. The Anti‑Kickback Statute prohibits offering or paying anything of value to induce the referral of items or services covered by Medicare, Medicaid, and other federal healthcare programs.
15:39 [Zero Hedge] (E)
In a move that will send shockwaves across the $3.5 trillion US healthcare industry, on Friday the Trump administration unveiled a plan that would - for the first time - force hospitals and insurers to disclose their secret negotiated rates, the WSJ reported.
22:22 [Livescience] (E)
Vitamin E acetate was found in all the lung fluid samples taken from patients with EVALI.
11:49 [Press TV] (E)
US health officials on Thursday reported 33 deaths and 1,479 confirmed and probable cases so far from a mysterious respiratory illness tied to vaping.