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To help prevent recurrences of medical device-related adverse events, Ireland has launched a national eAlert system intended for healthcare facilities. Read More
Hospitals and other healthcare institutions must follow certain administrative measures for quality supervision on the use of medical devices, under a new regulation issued by China’s FDA that focuses on procurement, maintenance, supervision and documentation. Read More
The FDA is aiming to develop additional documents and policies to help investigators and devicemakers understand Critical to Quality factors. Read More
Belgium-based Euromi was slapped with a far-ranging FDA warning letter that chides the company for not properly handling complaints, including instances in which cannula tips from a liposuction system broke and became lodged in patients. Read More
Following the outbreak of infections related to a deadly superbug, the FDA has provided new guidelines to help healthcare facilities ensure their duodenoscopes are cleaned adequately. Read More
A bipartisan group of lawmakers is calling on the head of the U.S. Government Accountability Office to investigate why power morcellators remained on the market for more than two decades before being slapped with a black box warning last year. Read More
The UK’s Medicines and Healthcare products Regulatory Agency has successfully prosecuted two companies it says supplied defective prefilled syringes whose use resulted in a diabetic patient’s death in 2010. Read More
Following the outbreak of infections related to a deadly superbug, the FDA has provided new guidelines to help healthcare facilities ensure their duodenoscopes are cleaned adequately. Read More
Belgium-based Euromi was slapped with a far-ranging FDA warning letter that chides the company for not properly handling complaints, including instances in which cannula tips from a liposuction system broke and became lodged in patients. Read More
A bipartisan group of lawmakers is calling on the head of the U.S. Government Accountability Office to investigate why power morcellators remained on the market for more than two decades before being slapped with a black box warning last year.
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