Supply Chain

Latest Issue of OR Manager
June 2019
Home Supply Chain/Technology > Supply Chain

FDA: Class I recall of Ethicon circular staplers

Editor's Note The Food and Drug Administration (FDA) on May 16 identified the recall by Ethicon of its Endo-Surgery and Endo-Surgery Endoscopic Curved Intraluminal Staplers with adjustable height staples as Class I, the most serious. The recall was initiated because Ethicon confirmed that uncut washers in the staplers and malformed…

Read More

By: Judy Mathias
May 16, 2019
Share

FDA issues alert on premature battery depletion in certain Medtronic pacemakers

Editor's Note The Food & Drug Administration (FDA) on May 7 issued a Safety Alert on the risk for premature battery depletion in nearly 132,000 biventricular and conventional cardiac resynchronization therapy implantable pacemakers by Medtronic. The FDA is aware of three patients in which a battery fully drained because of…

Read More

By: Judy Mathias
May 9, 2019
Share

FDA: Class I recall of Neuro Omega System

Editor's Note The Food and Drug Administration (FDA) on May 6 identified the recall my Alpha Omega Engineering of its Neuro Omega System, including the Drive Headstage unit, as Class I, the most serious. The recall was initiated because a design flaw in the device may connect two separate electrode…

Read More

By: Judy Mathias
May 8, 2019
Share

FDA: Class I recall of Miller and Fogarty Atrioseptostomy Dilation Catheters

Editor's Note The Food & Drug Administration (FDA) on April 26 identified the recall of Edwards Lifesciences' Miller and Fogarty Atrioseptostomy Dilation Catheters as Class I, the most serious. The recall was initiated because of reports of difficulty in balloon deflation after deployment, which may lead to balloon fragmentation or…

Read More

By: Judy Mathias
April 30, 2019
Share

FDA issues draft guidance on initiating voluntary recalls

Editor's Note The Food and Drug Administration (FDA) on April 23 issued a new draft guidance to help manufacturers avoid delays in preparing, planning, and executing voluntary recalls. The guidance includes recommendations in three areas: proper training of personnel thorough and organized record keeping written recall initiation procedures. The guidance…

Read More

By: Judy Mathias
April 25, 2019
Share

FDA announces new efforts to protect patients from risks associated with surgical staplers, implantable staples

Editor's Note The Food & Drug Administration on April 23 announced new steps it will be taking to help reduce risks associated with surgical staplers for internal use and implantable staples. The proposed steps include: Reclassifying surgical staplers from Class I (low risk) to Class II (moderate risk). Issuing guidance to…

Read More

By: Judy Mathias
April 23, 2019
Share

FDA orders manufacturers to stop selling gynecologic mesh

Editor's Note The Food and Drug Administration (FDA) on April 16 announced that it had ordered manufacturers of surgical mesh products indicated for transvaginal repair of pelvic organ prolapse to stop selling and distributing their products in the US, immediately. The FDA has determined that manufacturers, Boston Scientific and Coloplast,…

Read More

By: Judy Mathias
April 22, 2019
Share

FDA: Class I recall of Brainlab Spine & Trauma 3D Navigation Software

Editor's Note The Food & Drug Administration (FDA) on April 15 identified the recall of Brainlab's Spine & Trauma 3D Navigation Software as Class I, the most serious. The Software is being recalled because of the potential for incorrect information to display during surgery, which may prevent the surgeon from…

Read More

By: Judy Mathias
April 16, 2019
Share

ECRI Institute announces Healthcare Supply Chain Achievement Award winners

Editor's Note The ECRI Institute on April 1 announced the 11 US healthcare organizations that received its 2019 Healthcare Supply Chain Achievement Award. The winners demonstrated excellence in overall spend management in their supply chain processes, and include: Albany Medical Center, Albany, NY Cambridge Health Alliance, Cambridge, MA Cooperative Services…

Read More

By: Judy Mathias
April 3, 2019
Share

FDA addresses potential medical device, product shortages amid shutdown of sterilization facility

Editor's Note The Food & Drug Administration on March 26 said it will take steps to address potential medical product and device shortages because of the recent closure of a large contract sterilization facility, Sterigenics (Willowbrook, Illinois). Earlier this year, the Illinois Environmental Protection Agency issued an order to stop…

Read More

By: Judy Mathias
March 27, 2019
Share
OR Manager Jobs
Upcoming Webinars
Live chat by BoldChat