Category: Recalls



Medtronic Announces Voluntary Field Corrective Action for Ventilator Series

Medtronic is notifying customers worldwide of a voluntary field corrective action—a software update—for its Puritan Bennett 980 (PB980) ventilator series. The software updates the external USB Drive performance and its impact on Graphical User Interface (GUI) functionality and the labeling displayed on the GUI during ventilator use, Medtronic said in a statement.

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Study: Managers Rely on Physicians to Screen Out Medical Device Defects

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.

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Identifying Recalls and Non-Recalls

In 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.

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Ready for Recalls?

Although 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.

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Product Recall Management 101

As 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.

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FDA to Speed Posting of Product Recalls

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.

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Crisis Averted: Preparing for a Device Recall

When 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.

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Updated Recall Management Tool Pairs Alerts to Hospital Equipment Inventory

ECRI 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.

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Creative Problem Solving and the Future of HTM

Now 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.

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End Times: Planning for Capital Equipment Purchases

Clinical 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?

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