FDA proposes early warning system for potential medical device safety issues
The Food and Drug Administration (FDA) has issued draft guidance that would establish an early warning system to alert the public to possible safety issues with medical devices before the agency has investigated whether a serious risk actually exists.
The FDA currently issues press releases, recalls and safety communications to alert the public of safety concerns after a device has entered the market. These alerts are released after the FDA has investigated the issue and determined what to do about it. The administration system says an "emerging signals" system can help to subvert potential harm as an investigation is being completed.
The FDA notice states that "timely communication about emerging signals is intended to provide health care providers, patients and consumers with access to the most current information concerning the potential benefits and risks of marketed devices, so that they can make informed treatment choices based on all available information. Such communication also may reduce or limit the number of patients exposed to the potential risk while the issue is being evaluated further.
According to the draft guidance, the FDA will consider a number of factors when determining whether an issue should be identified as an emerging signal, including the seriousness of the adverse event and the strength of evidence showing a causal relationship between using the device and the adverse event.
Also this week:
Senate committee issues recommendations preventing infections linked to duodenoscopes
A report form the Senate Committee on Health, Education, Labor, and Pensions reviewed the link between patient infections and improper cleaning of medical devices. The report "Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients" advises that the Food and Drug Administration develop a more robust medical device surveillance system.
AHA recommends changes to improve rural access to broadband connections
The American Hospital Association (AHA) recommended several changes to the Federal Communications Commission's (FCC) Healthcare Connect Fund to improve access to broadband for rural health care services.
"Growth in the use of electronic health record, technology-based patient engagement strategies, telehealth and remote-monitoring technologies all require access to robust broadband connections," noted Ashley Thompson, AHA senior vice president for public policy analysis and development in comments submitted to the FCC.
ASIS and NFPA to launch active-shooter emergency preparedness initiative
The National Fire Protection Agency and ASIS International have launched a joint initiative to address active-shooter incidents. A kickoff stakeholder meeting in Arlington, Va., on Jan. 19 will bring together more than 50 standards developers, industry groups, law enforcement members, government officials and academia professionals to explore the administrative, management and technology issues related to active-shooter events.
"By implementing the best technology, architectural and management strategies, we can strengthen our defenses and resilience against active shooters," says Robert Solomon, division manager, building fire protection, NFPA. "Given the short response time to active-shooter incidents, people need the technology and training to buy time essential to survival and to minimize losses and consequences of an attack."
Water Research Foundation launches project to reduce hospital discharges
A new project from the Water Research Foundation will seek to reduce the loading of contaminants of emerging concern (CEC) being discharged from hospitals and other health care facilities. The project, Hospital Discharge Practices and Contaminants of Emerging Concern in Water, will investigate current regulations and discharge practices for hazardous materials, and provide data to formulate feasible actions to reduce the amount of CECs entering the water system due to modern health care practices. The study will look into chemical contaminants, as well as microbial contaminants.
