ECRI Blog

The EtO Sterilization Dilemma

Ethylene oxide (EtO) sterilization has been in the news a lot lately, and healthcare has much at stake. According to officials at the U.S. Food and Drug Administration (FDA), approximately 56% of all critical medical devices are sterilized using industrial EtO sterilization. Currently, there are no validated industrial alternatives, so additional closures of EtO processing facilities would have the potential to impair the U.S. healthcare system.

While some state legislators are considering bans on industrial EtO sterilization facilities, healthcare leaders, manufacturers, and FDA have been reviewing options to ensure the availability of sterile medical devices and supplies necessary for patient care.

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Topics: Health Devices, Patient Safety, Supply Chain

4 Ways to Prevent Harm from Surgical Staplers

If you’ve been following medical device safety issues this year, there’s a good chance you’ve seen the headlines about patient injuries and deaths related to internal surgical staplers. The devices are commonly used in many high-risk surgical procedures. Misuse and malfunction of surgical staplers can lead to serious complications—as we’ve seen during our own research and accident investigations.

The stapler cases we investigate tend to be associated with serious injuries or fatalities, some of which could have been prevented. The overall adverse event rate is low relative to the number of times staplers are used; however, cases of preventable death are chilling. This has led ECRI Institute to thoroughly research and evaluate staplers and to publish safety hazards to our members. In fact, surgical staplers have appeared twice on our annual list of Top 10 Health Technology Hazards— first in 2010 and again in 2017.

So, why is this decades-old technology in the news now? And, more importantly, what can you do to keep patients safe?

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Topics: Health Devices, Patient Safety, Accident Investigation

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