Briefs
FDA Finalizes Ban on Powdered Gloves
The FDA has finalized a ban on most powdered gloves in the U.S., as the agency says they pose unreasonable and substantial risks that cannot be corrected through new or updated labeling.
The final rule is substantively identical to a proposed rule issued in March (IDDM, March 25), except for clarifying that the ban applies to all powdered patient examination gloves and powder surgical gloves, regardless of the material from which they are made. According to the FDA, language in the proposed rule could have been interpreted to mean that only powdered natural rubber latex and powdered synthetic latex gloves were banned, which was not the agency’s intent.
Read the final rule here: https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-30382.pdf.
FDA Finalizes Rule on Pediatric Hospital Beds
A FDA final rule renames pediatric hospital beds as pediatric medical cribs and establishes special controls for these devices.
The rule also creates a separate regulation that places medical bassinets in Class II and establishes special controls.
The rule stems from reports of malfunctions in medical cribs such as drop-sided rails not latching, and reports of medical bassinet tipping or not being cleaned properly.
Read the final rule here: www.fdanews.com/12-16-16-cribs.pdf.
Gordian Surgical Gets FDA Clearance for TroClose1200
Gordian received FDA clearance for TroClose1200, a trocar with a combination closure system for the binding of abdominal wall incisions during minimally invasive surgical procedures.
The device is a 2-in-1. It serves as a trocar, which opens the abdomen and closes internal incisions made during surgery.
Gordian received a CE Mark in September.
FDA Expands Clearances for AMI’s TubeClear System
Actuated Medical has received additional FDA clearances for TubeClear therapy system.
This clearance allows the device system to be utilized in feeding tubes as narrow as 2mm and decompression tubes 2mm to 3mm in adult patients.
The device is also cleared to not only be cleaned by other health professionals whose patients have clogged feeding tubes, but also while the tube is implanted in the patient.
Provision Healthcare Obtains FDA Clearance for SC360 Therapy System
ProNova Solutions gained FDA clearance for SC360 proton therapy system.
The device is a patient-bed scanning radiation system that treats cancer patients at all angles without moving the patient.
Centurion Issues Recall on Multi-Med Single Lumen Catheters
Centurion Corp. has recalled convenience kits that have multi-med single lumen catheters due to potential excess material that remains at the tip of the catheter from the manufacturing process.
The catheter is used to sample blood and administer drugs or fluids. This manufacturing error can lead to separation during use and cause blood clots, embolisms and even death.
FDA Awards Lumendi Marketing Clearance for DiLumen
Lumendi has received FDA marketing clearance for DiLumen, an endoscopic device used in the surgical treatment of colon lesions.
DiLumen is a flexible single-use sheath component that attaches to the end of a colonoscope. During surgery, the sheath expands its two balloons to widen the stomach tubes to create an operable area to treat stomach lesions.
FDA Grants ISO 13485:2003 Certification to Eclipse Aesthetics
Eclipse Aesthetics achieved ISO 13485:2003 certification and the total use of their quality management systems.This certification allows the company to continue manufacturing its platelet-rich plasma kit, Eclipse PRP.