Using X-Ray Technology to Sterilize Medical Devices
X-ray sterilization combines the best features of E-beam and gamma techniques, offering rapid turnaround times, processing flexibility, good pallet configuration processing, and relatively low dose ratios.
Are These Medical Devices Too Dangerous?
Activists say these devices harm patients and should be recalled or outright banned, while the companies that make the products insist they're safe. Who do you believe?
Are These Medical Devices Too Dangerous? (Excimer Lasers for LASIK Surgery)
Excimer Lasers for LASIK Surgery
Excimer lasers are used in LASIK surgery to reshape the cornea in order to improve eyesight. Hundreds of thousands of U.S. patients undergo LASIK procedures each year, and to date FDA has approved more than 30 excimer lasers for LASIK. But risks of the proced...
Are These Medical Devices Too Dangerous? (Stryker Wingspan Stent System)
Stryker Wingspan Stent System
Approved under an HDE in 2005, the Stryker Wingspan Stent System was greenlighted for use in patients with treatment-resistant (refractory) intracranial atherosclerotic disease who have 50% or greater narrowing in the intracranial arteries. The device is us...
Are These Medical Devices Too Dangerous? (Dental Amalgam)
Dental amalgam, a filling for cavities, can release low levels of mercury vapor that can be inhaled and has been associated with allergic reactions or sensitivities in some people, according to FDA. The material has been used for more than 150 years in hundreds of millions of patie...
Are These Medical Devices Too Dangerous? (Transvaginal Mesh)
From 2006 to 2009 FDA received more than 1000 adverse event reports about the mesh products used in transvaginal surgical repair of pelvic organ prolapse and stress urinary continence. Problems ranged from pain and infection to mesh erosion and recurrence of prolapse or incon...