Medtronic Stent Graft Recall Is Serious
Medtronic has recalled the Valiant Navion thoracic stent graft system due to stent fractures and endoleak concerns. But the FDA has categorized the recall as Class 1, the most critical kind.
Medtronic has recalled the Valiant Navion thoracic stent graft system due to stent fractures and endoleak concerns. But the FDA has categorized the recall as Class 1, the most critical kind.
BD subsidiary CME America announces a voluntary recall for all CME America BodyGuard Infusion System Administration Sets—used with the company’s BodyGuard infusion pumps—that were distributed beginning May 2016.
The U.S. FDA has recalled certain Medtronic MiniMed insulin pumps due to potential cybersecurity risks and recommends that patients using these devices switch their insulin pump to models that are better equipped to protect against these potential risks.
In order to reduce the lag time between manufacturer action and FDA posting, the FDA announced in January that it would begin posting product recalls in the Medical Device Recall database before the agency’s own classification procedure ran its course. It will be a marked improvement from how things have been in the past, maintains biomedical expert William Hyman, ScD.
Read MoreWhen handled well—with the right messages—product recalls can improve a brand or company image. On the other hand, if a recall is handled badly, the damage can be fatal. The level of preparedness by a manufacturer going through a crisis can make or break its ongoing success and vitality. Fortunately, reacting quickly and being proactive with messaging is possible. It just takes adequate preparation.
Read MoreECRI Institute has released Automatch for Equipment, a new enhancement to its Alerts Tracker automated recall management solution. The feature is designed to automatically identify equipment models and supplies within a healthcare facility’s inventory that are impacted by an FDA alert or recall and notify designated department staff, reducing the need for manual inventory searches.
Read MoreNow more than ever, creative thinking and problem solving are integral to the healthcare technology management profession, says George Mills of The Joint Commission. Today’s clinical engineers must develop the relationship between IT and patient care and understand the interconnectedness of hospital systems. This article is part of 24×7’s 20th anniversary coverage.
Read MoreJonathan Gaev of ECRI Institute considers the evolution of medical equipment and healthcare technology management, and where the future of the profession is headed. This article is part of 24×7’s 20th anniversary coverage.
Read MoreSince William Hyman published his report on the Food and Drug Administration’s call for comments regarding repair and refurbishment of medical equipment by OEMs and third parties, 24×7 readers have had a lot to say.
Read MoreClinical engineering plays a central role in planning for the replacement and acquisition of new capital equipment. The data you provide will directly impact the day-to-day operations and financial well-being of your organization for years to come. So what information do you need to provide, where do you get it, and who needs to receive it?
Read MoreNow that the January 1, 2016 deadline to implement the second phase of The Joint Commission’s National Patient Safety Goal concerning clinical alarm management has passed, hospital leaders reflect on the road ahead.
Read MoreAsk ten different biomeds what’s most challenging about their job, and chances are you’ll end up with ten different answers. 24×7 asked three industry veterans for their expert opinions on the most important issues facing the healthcare technology management field, and then boiled down their thoughts to arrive at a “top 10.” Among their responses? Ensuring supportability, creating actionable data, and increasing training in “systems thinking.”
Read MoreNew tools are emerging in the healthcare space that are so full of potential, it’s anyone’s guess what their impact may be. Some of these trends may prove to be fleeting, or merely a stepping stone to something else, but others may ultimately transform the entire industry.
Read MoreBiomeds don’t only need to understand the distinction between FDA-cleared and FDA-approved devices for the medical equipment selection process, writes William Hyman. By using the proper terminology, they can help educate clinicians as well.
Read MoreECRI Institute has launched TruVu, a decision-making tool designed to help hospitals move away from emotionally-driven technology purchases. The platform allows stakeholders to see the impact of a change to a product feature, service contract price, or physician preference on a shared platform before making a purchasing decision.
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