Why the FDA took years to warn about scope-related infections

Staff at the federal agency losing the report was one of many missteps


The staff at the Food and Drug Administration losing a report was one of many missteps that cause the FDA to take years to warn about scope-related infections, according to an article on the L.A. Times website.

The missing paperwork, revealed in a recent Senate inquiry, underscores the serious shortcomings in the antiquated national database used to monitor the safety of medical devices, which even the FDA has long admitted is flawed, the article said.

The speedy implementation of a new system has hit a roadblock put up by opponents who say an essential part of the upgrade will cost too much.

A 2007 requiring that each device get a unique number had no deadlines. A trade group of the nation's hospitals and Medicare directors say adding a line to the standard insurance claim form so that the device numbers can be recorded is too expensive.

Read the article.

 

 



February 11, 2016


Topic Area: Industry News


Recent Posts

Parking: Where the Outpatient Land Crunch Shows First

Healthcare systems that treat parking as a strategic design variable from the first feasibility pass will have more sites to choose from.


Clear Behavioral Health Opens New Outpatient Mental Health Center in Anaheim Hills

It offers an intensive outpatient program (IOP) for adults and teens ages 13 to 17 across east Anaheim and the surrounding communities.


Bon Secours Begins Construction on Freestanding Emergency Department in Norfolk

It is expected to open in late 2027.


The OR HVAC Puzzle: Why Individual Systems Are on the Rise

Extra penetrations, tight clearances and strict humidity needs—design experts explain what it really takes to plan dedicated units for each operating room.


Skanska Completes Renovation of Specialized Care Facility for Sutter Health

The project was delivered through a highly coordinated effort, utilizing advanced construction methodologies to maintain efficiency.


 
 


FREE Newsletter Signup Form

News & Updates | Webcast Alerts
Building Technologies | & More!

 
 
 


All fields are required. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.