Medical Device Makers Report Malfunctions And Patient Injuries In FDA Database Hidden From Public ViewKaiser Health NewsAgency records provided to KHN show that more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program in 2017 alone. Alison Hunt, another FDA spokeswoman, said the majority of device makers’ “exemptions” were revoked that year as a program took shape that requires a summary report to be filed publicly. More than a million reports of malfunctions or harm spanning about 15 years remain in a database accessible only to the FDA. But with the agency’s new transparency push, the public may find a public report and submit a Freedom of Information Act request to get information about incidents. A response can take up to two years. The long-standing exemption program “has allowed the FDA to more efficiently review adverse events … and take action when warranted without sacrificing the quality of our review or the information we receive,” Hunt said in an email. Madris Tomes(Courtesy of Madris Tomes) To those outside the agency, though, the exceptions to the reporting rules are troubling. They strike Madris Tomes, a former FDA manager, as the agency surrendering some of the strongest oversight and transparency powers it wields. “The FDA is basically giving away its authority over device manufacturers,” said Tomes, who now runs Device Events, a website that makes FDA device data user-friendly. “If they’ve given that up, they’ve handed over their ability to oversee the safety and effectiveness of these devices.”
Over-engineering a watchA Polish tourist comes back home after visiting the USSR. He carries two very large and heavy suitcases. On his wrist is a new Soviet-made watch. He tells the customs man: "This is a new Soviet watch. It's a wonder unknown in the capitalist countries. You see, it shows time, the rate of your pulse beats, the phases of the Moon, the weather in Warsaw, Moscow, and New York, and more and more!" "Yes, it's a wonder," the customs man agrees. "And what is it you have in these big suitcases?" "Oh, it's just the batteries for that watch."
We're told the extent to which Rosenberg and Wojcicki overlapped is a matter of dispute between the separated philanthropists—but even if they can split amicably, knowing that one of the most vital, powerful men at the company has been using Google's most ambitious product as a dating pool won't be smooth news for the rest of the team. And of course, the odds of grotesquely 21st century sex tape existing are now very high.