ECRI Blog

Timothy Gibson, Manager, Functional Equivalents, Supply Guide

Recent Posts

Recall: 3M Steri-Drape Defect Can Render Product Unusable and Unsafe

Recently, 3M™ issued an urgent, voluntary recall of select models and lots of 3M™ Steri-Drape™ Surgical Drapes distributed between October 29, 2021, and August 25, 2022.

How is the drape used?

The Steri-Drape is made from clear polyethylene plastic with a matte finish, which includes an adhesive strip. It is used as a surgical drape for patients during procedures. This drape is intended to absorb liquids with no strike-through to decrease the risk of microbial migration, and function as a barrier to skin.

The effected products include: 3M™ Steri-Drape™ Surgical Drapes, Catalog Numbers 1000, 1000NS, 1000NSD, 1010, 1010NS, 1010NSD, 1020, 1020NS, 1021, 1021NS, 1030, 1030NS, 1033, 1060, 1060NS, 1061, 1061NS, and 1071.

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Topics: Supply Chain

4 Ways to Manage the Tracheostomy Tube Shortage

In one of the latest challenges for the embattled healthcare supply chain, the U.S. Food & Drug Administration (FDA) reported that there is now a shortage of tracheostomy tubes, especially pediatric tracheostomy tubes.

"This supply chain disruption disproportionally affects the pediatric population due to the already limited number of products available for this patient population and the spike in cases of respiratory illnesses in children," says Jillian Hillman, ECRI's senior manager, Functional Equivalents - Device Evaluation.

To help reduce the burden on healthcare providers and promote patient safety, ECRI has issued this functional equivalents report. ECRI will offer updated guidance as this situation unfolds.

The shortage includes the Bivona® tracheostomy tubes manufactured by ICU Medical. The shortage may be related to difficulties in getting the raw materials needed to make the tracheostomy tubes. 

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Topics: Supply Chain

Functional Equivalents for Surgical Staplers: See ECRI's List Here

While COVID-19 has waned, it has not yet disappeared. Schools, community leaders, and healthcare providers continue to closely “watch the numbers” to ascertain local infection rates and take actions and precautions accordingly. While they do that, business leaders, especially those in the healthcare industry, continue to watch another indicator—the supply chain and its disruptions.

In addition to the pandemic, several other forces have continued to disrupt the supply chain. Recent labor strikes, worker shortages, production slow-downs or stoppages, and war continue to impact the supply chain. To date, the healthcare industry and general public have experienced shortages in personal protective equipment (PPE), baby formula, and now surgical staplers.

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Topics: Supply Chain

RECALL: Palindrome and Mahurkar Hemodialysis Catheters and How to Find Alternative Products

Recently, Covidien, LLC, a subsidiary of Medtronic, recalled Palindrome and Mahurkar hemodialysis catheters due to a catheter hub defect. Once again, we are reminded that patient safety and supply chain are not separate parts of healthcare that should function independently of each other. Rather, their interdependence is vital to increasing patient safety and optimizing clinical outcomes; creating efficient, safe, and successful working environments; and maintaining the fiscal viability of healthcare facilities, be they large or small, private or public.

The COVID-19 pandemic brought this simmering issue to the surface, and healthcare provider organizations are getting smarter about preparing for the unexpected and strengthening their supply chains. ECRI has long offered such advice and support, and we continue to expand and strengthen our guidance, specifically in the area of providing trustworthy, independent functional equivalent information and  vendor information that is available quickly, easily, and cost-effectively—most importantly, it’s reliable information.

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Topics: Supply Chain

3 Ways ECRI’s New Functional Equivalents Report Will Help YOU Master Supply Chain Disruptions

The supply chain issues of the last couple years show little signs of improving. Production slowdowns or stoppages, worker shortages, escalating costs, transportation issues, war, weather and other difficulties will continue. But what is improving is the ability of those in the healthcare sector to better plan for expected and unexpected challenges.

Buzz words such as cross functional integration in supply chain management and equipment equivalency guidelines or functional equivalence examples, are now part of the vernacular. And that’s a good thing; it means we’ve learned from the challenging experiences of the pandemic, and we are now better prepared to continue to navigate COVID-19, Monkey-pox, natural disasters, or whatever other hardships come our way.

A key trait shared by the healthcare facilities that have best learned how to navigate today’s supply chain is a willingness to do things differently, to partner with supply chain leaders, such as ECRI, or with “sister facilities” and even competitors. These partnerships have led to greater knowledge, insights, resource sharing, and support than ever before. And, organizations are refining and formalizing guidance.

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Topics: Supply Chain

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