Reuse Data From OEMs Could Jumpstart FDA Policy-making Effort
This article was originally published in The Gray Sheet
Executive Summary
Approximately 80% of commercially reprocessed biopsy forceps are not completely sterilized prior to reuse, according to data submitted to FDA by the Association of Disposable Device Manufacturers.
You may also be interested in...
FDA Reuse Policy Demands Data From Both OEMs And Reprocessors
FDA's revised policy on reprocessing of disposable medical devices would require manufacturers seeking to label a product as single-use only to submit data demonstrating that it cannot adequately be reprocessed, FDA staffers report.
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.