Standards/Regulations

Latest Issue of OR Manager
December 2017
Home Regulations/Legal > Standards/Regulations

FDA updates Safety Alert for urogynecologic surgical mesh by Boston Scientific

Editor's Note The Food and Drug Administration (FDA) on September 19 updated its Safety Alert for urogynecologic surgical mesh manufactured by Boston Scientific. After an extensive review of data and testing, the FDA has determined that the change in supplier of the polypropylene used to manufacture the mesh currently on…

Read More

By: Judy Mathias
September 19, 2017
Share

Can HAI data be useful in differentiating US hospitals?

Editor's Note There are enough healthcare-associated infection (HAI) data reported on the Centers for Medicare and Medicaid Services (CMS) Hospital Compare website to meet minimal criteria for useful hospital comparisons in many geographic areas; however, it varies by type of HAI, this study finds. The analysis included data from 4,561…

Read More

By: Judy Mathias
September 18, 2017
Share

FDA: OriGen recalls two lots of dual lumen ECMO catheters

Editor's Note The Food and Drug Administration (FDA) on September 13 announced the recall by OriGen Biomedical (Austin, Texas) of two lots of its VV28F Reinforced Dual Lumen ECMO [extracorporeal membrane oxygenation] Catheters (Catalog number VV28F, Lots N18487 and V18487-1). The recall was initiated because the catheters have the potential…

Read More

By: Judy Mathias
September 14, 2017
Share

Joint Commission issues Sentinel Event Alert on inadequate hand-offs

Editor's Note The Joint Commission on September 13 announced a new Sentinel Event Alert that focuses on inadequate hand-offs and tips to improve them. A common problem with hand-offs is communication, which is the focus of “Sentinel Event Alert, Issue 58: Inadequate hand-off communication.” The alert includes an infographic of…

Read More

By: Judy Mathias
September 14, 2017
Share

Children’s Hospital Colorado alerts patients of data breach

Editor's Note Officials at Children’s Hospital Colorado in Aurora are sending notifications to nearly 3,400 patient families about a data breach that may have compromised their health information, according to the September 11 Becker’s Health IT & CIO Review. On July 11, investigators found an unauthorized person may have accessed…

Read More

By: Judy Mathias
September 13, 2017
Share

FDA to staff new digital health unit

Editor's Note The Food and Drug Administration (FDA) is filling 13 positions in a new digital health unit that was created as part of the FDA Reauthorization Act of 2017, the September 11 FierceHealthcare reports. The FDA intends to build a group of experts who are experienced with software lifecycle…

Read More

By: Judy Mathias
September 13, 2017
Share

FDA: Class I recall of Datascope/MAQUET intra-aortic balloon pumps

Editor's Note The Food and Drug Administration (FDA) on September 6 categorized the recall by Datascope/MAQUET of its CS100i, CS100, and CS300 intra-aortic balloon pumps as Class I, the most serious. The recall was initiated because of a false blood detection alarm and ingress of fluid into the balloon pump.…

Read More

By: Judy Mathias
September 11, 2017
Share

FDA: Genetech recalls three lots of Activase

Editor's Note The Food and Drug Administration (FDA) on September 7 announced the recall by Genetech (South San Francisco, California) of three lots of Activase (alteplase) 100 mg vials that were co-packaged with sterile water for injection. The vials of water, manufactured by Hospira Inc (Lake Forest, Illinois), may be…

Read More

By: Judy Mathias
September 11, 2017
Share

FDA: Recall of Hydromorphone HCL and Levophed Injection by Hospira

Editor's Note The Food and Drug Administration (FDA) on September 5 announced the recall by Hospira Inc (Lake Forest, Illinois) of one lot of Hydromorphone HCL injection, USP, CII 2 mg/mL and four lots of Levophed (norepinephrine bitartrate) injection because of a lack of sterility assurance resulting from a damaged…

Read More

By: Judy Mathias
September 6, 2017
Share

CMS grants exceptions for quality reporting to ASCs in Harvey’s path

Editor's Notes The Centers for Medicare & Medicaid Services (CMS) will grant exceptions for quality reporting requirements for ambulatory surgery centers (ASCs) located in the path of Hurricane Harvey, the September 1 ASCA News reports. ASCs in affected counties and parishes in Texas and Louisiana will get exceptions without having…

Read More

By: Judy Mathias
September 6, 2017
Share
Hot Products
Product Spotlight: Stryker SurgiCount Safety-Sponge System

SurgiCount Safety-Sponge System – the total package for retained surgical sponge prevention, utilizes uniquely identified surgical/laparotomy sponges and towels to provide a precise

Live chat by BoldChat