FDA 2020 Recall Roundup: A Rough Year for Infusion Pumps
Infusion pumps or their components account for nine entries in the FDA’s list of 2020 medical device recalls.
Infusion pumps or their components account for nine entries in the FDA’s list of 2020 medical device recalls.
GE Healthcare has recalled its Carestation 620/650/650c A1 anesthesia systems because there is a potential for a loose cable connection inside the system, which may cause the mechanical ventilation to stop working.
The repair and maintenance of medical lasers can play a significant role in a typical biomedical technician’s duties. But vague regulatory guidelines are causing confusion about who is qualified to maintain the equipment and which procedures should be followed.
Results of a new study into what influences the decision to recall a defective product found that medical device firm managers may rely on their physician-customers to screen out detectable defects, in lieu of issuing a recall. The study also found that some managers appear to hesitate to recall a product until the root cause of the defect is clearly understood, because this can reduce recall costs to the firm.
Read MoreIn the latest Soapbox column, biomedical engineering educator and expert, William Hyman, takes a closer look at the logistical challenges and difficult decisions triggered by the FDA’s ‘Do Not Use’ recalls on medical devices. Don’t miss out.
Read MoreAlthough medical device recalls can be a challenge for any hospital, new regulations and technologies are starting to make this work a little easier, says seasoned writer Chris Hayhurst in October’s cover story. So, is your facility ready for a product recall? Assess your readiness here.
Read MoreAs part of your overall biomedical equipment management strategy, you should maintain a product recall process that allows your organization to react quickly and decisively to a recall situation, enBio Corp.’s Mike Murray and Arthur Zenian say. Below, they share how to accomplish this.
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 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 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 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.
Read MoreIn the second of two articles explaining the basics of the Ethernet protocol, Networking columnist Jeff Kabachinski examines the Ethernet packet structure to show how the Ethernet recipient portion of the protocol operates.
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