The U.S. Agency for Healthcare Research and Quality (AHRQ) said reductions in hospital-acquired conditions (HACs) have helped to prevent more than 20,000 hospital deaths between 2014 and 2017, and have shaved $7.7 billion from hospital spending over the same term. AHRQ said HACs were reduced by more than 900,000 in that time, and that the rate of such events fell from about 99 to 86 per 1,000 acute-care episodes. The target reduction for federal government hospital safety programs is to cut the incidence of HACs by 20 percent between 2014 and 2019, and that the achievement of that objective would mean 1.8 million fewer HACs, 53,000 fewer deaths, and savings in excess of $19 billion.
Health Canada said the launch of its medical device regulatory e-learning tool is an interactive platform that provides targeted guidance for device makers while drafting their premarket submissions. The agency said the tool provides a comprehensive and organized source of regulatory information for a variety of stakeholders, including consultants and academia, and that the availability of the tool may help improve the quality of premarket filings.
Japan's Pharmaceutical and Medical Devices Agency said it had approved a number of medical devices between April and September 2018, including the Lutonix drug-coated balloon for the femoropopliteal arteries, which required 222 days overall and 90 days of agency time. Medicon Inc., a subsidiary of Lutonix, was the listed sponsor of the device. Among the other devices and diagnostics approved in that time are the Oncomine Dx test by Life Technologies Japan Ltd. and the Mobi C artificial cervical disc by Zimmer Biomet Inc. subsidiary Zimmer Biomet G.K. Medtronic's Sofamor Danek subsidiary received a regulatory nod for the Prestige LP cervical disc system, while Coviden and Boston Scientific also won approvals, the former for the Cool-Tip radiofrequency ablation catheter for soft organ coagulation, and the latter for the RFA radiofrequency ablation catheter, likewise for soft organ coagulation.
The International Medical Device Regulators Forum (IMDRF)posted the final edition of the assembly and technical guide for table of contents (ToC) submissions, dated Jan. 24, 2019, but not posted until March 20. The IMDRF noted that device makers interested in regulatory filings in multiple jurisdictions may choose to develop a copy of the ToC for a product in a manner that is regulator-agnostic, then adapting the device-specific template for each regulatory region of interest. The group noted that the PDF file type is the preferred file format, although some agencies will take applications in other formats, such as word processing and spreadsheet file types.
Sientra Inc., of Santa Barbara, Calif., said in a March 20 statement that it intends to respond within 15 days to the U.S. FDA warning letter for the company's Section 522 studies for breast implants. Sientra said it had employed a number of methods for encouraging study retention, and that the company will continue "to work collaboratively with the FDA for a prompt resolution" to the problems seen in loss to follow-up. The statement noted that Sientra will discuss the problems in the March 25-26 advisory committee hearing.