Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


There's A Pediatric Air-Tube Shortage Because A Sterilization Facility Was Shut Down

Executive Summary

After an Illinois sterilization facility was shut down earlier this year, the US FDA says it has resulted in a temporary shortage of Bivona emergency breathing devices for children. The agency is working with the manufacturer, Smiths Medical, to figure out a solution quickly, but won’t have new inventory on the market for at least another week.

You may also be interested in...

2019 US Regulatory Review: Risk Management, EtO, Quality, Medicare, QSR/ISO 13485 Harmonization Hot-Button Topics For Industry

The US medtech regulatory landscape in 2019 was capped at both ends by news of an ambitious rewrite of risk management standard ISO 14971, which was finalized in December. The international standard – used by most manufacturers that make and distribute medical devices within the United States – instructs device makers on how to best put together a risk management program. Other news of interest to readers last year included a rewrite of the US FDA’s Quality System Regulation (QSR) to harmonize it with ISO 13485, expanded Medicare coverage, troubles with ethylene oxide (EtO) used to sterilize devices – and much more. Here are 2019’s 10 most popular US regulation and policy stories from Medtech Insight.

Risk Of Sterilization Plant Shutdowns Across US Sends Shockwave Through Industry

While a number of US states are taking actions that could potentially ban or limit ethylene oxide (EtO) sterilization plants in their communities, the FDA, industry and others are raising the alarm that such moves could lead to a shortage of medical devices critical to patients.

Industry, AJC Duke It Out In Georgia Over Ethylene Oxide Risk

While AdvaMed has remained relatively quiet over the recent closures of ethylene oxide (EtO) sterilization facilities, the medical device industry advocacy group is taking on critics in Georgia, where two facilities have been paused to upgrade their operations to reduce EtO emissions. Critics – including the Atlanta Journal-Constitution’s editorial board – say the chemical is associated with increased risk for cancer for nearby residents, but AdvaMed and its supporters say there’s no evidence to back that up.

Related Content


Related Companies

Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts