IHA Daily Briefing: Nov. 26

Tuesday, November 26, 2019
FDA Announces Next Steps on EtO
Chicago City Council Approves Mayor's Budget
IHA HIIN Patient Safety Simulation Adds VAE Critical Care
IDPH Investigating E. Coli Outbreak, Link to Lettuce
Thanksgiving Turkey Safety Tips

FDA Announces Next Steps on EtO
The U.S. Food and Drug Administration (FDA) on Monday announced a series of steps it is taking to advance innovation in medical device sterilization techniques to reduce reliance on ethylene oxide (EtO) and to mitigate medical device shortages.

Moving on recommendations that the FDA received from its public advisory committee meeting held earlier this month, the agency says it will begin to work with medical device manufacturers to reduce the amount of paper (such as the labeling and instructions for use manuals) included in a sterile device package. The FDA notes that “when the sterilization load (i.e., all of the materials inserted into the sterilizer chamber with the device) includes a large amount of paper with the device, it hinders the ethylene oxide getting to the device and generally means that more ethylene oxide is required for effective sterilization.”

The agency is also acting on a second recommendation to expedite approvals of certain changes that medical device manufacturers make to EtO sterilization methods, processes and facilities. “Considering the recent sterilization facility closures and concerns about their impact on medical device availability, we recognize the need to facilitate timely process and site changes that may reduce the amount of ethylene oxide used and minimize the impact of supply interruptions,” the agency said. The FDA is asking sterilization facilities and device manufacturers to participate in a voluntary EtO Sterilization Master File Pilot Program.

The agency also said it had selected 12 of 46 applications it received for two new Innovation Challenges to identify new sterilization methods and technologies that are alternatives to those that use EtO and to identify strategies or technologies that can significantly reduce the amount of EtO used to sterilize devices.


Chicago City Council Approves Mayor's Budget
Early this afternoon, after two hours of debate, the Chicago City Council voted 39-11 to approve Mayor Lori Lightfoot’s fiscal year 2020 budget plan totaling $11.6 billion. The plan also raises the minimum wage to $15 by 2021, which will directly impact more than 430,000 workers in the city.

At a press conference after the council meeting, Mayor Lightfoot said, “This is a historic day for our city. With today’s vote, we not only closed a record $838 million budget gap. But we did it through a combination of progressive revenues and smart government efficiencies. While also strengthening investments in our communities most in need. And all of it delivered without a significant increase in property taxes. This was possible because we conducted a reform-minded process that was transparent, inclusive, and incorporated unprecedented levels of community input, including five budget town halls that drew over 2,600 residents. As a result, over 60 percent of the budget gap was closed through structural solutions—not one-time fixes. And for the first time in our city’s history, we have climbed the ramp to pay for our police and fire pensions at a level needed to ensure their long-term stability. Still, despite the historic challenges we faced in closing our budget gap responsibly, we still made key investments in affordable housing, homelessness, public safety, and mental health."

Further information about the FY2020 Chicago budget is available on the city’s budget portal.


IHA HIIN Patient Safety Simulation Adds VAE Critical Care
IHA’s Great Lakes Partners for Patients Hospital Improvement Innovation Network (HIIN) has added the new VAE Critical Care curriculum to its simulation training schedule. The first VAE training will be held on Wed., Dec. 11 from 10 a.m. to 4:30 p.m. at the Jump Trading Simulation and Education Center in Peoria.

These training events emphasize the use of simulation-based strategies to facilitate change in HIIN hospitals and provide attendees with simulation-based tools and techniques to augment the pursuit of higher quality care, patient safety and healthcare resiliency at the unit level.

It is not essential for learners to have access to high fidelity simulation labs or equipment to come to these events. The tools and strategies discussed may be implemented in any organization with any level of resources. The goal is to provide learners with another set of tools to engage their frontline staff to identify system problems that contribute to adverse outcomes related to ventilator-associated events (VAEs).

These sessions will be capped at 25 participants, so register now. All events are free of charge to Illinois HIIN hospitals. Logistical information will be provided after registration is completed.


IDPH Investigating E. Coli Outbreak, Link to Lettuce
The Illinois Dept. of Public Health (IDPH) says it is working with the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration, the U.S. Dept. of Agriculture, and public health and regulatory officials in other states to investigate a multistate outbreak of E. coli O157:H7 infections, possibly linked to romaine lettuce.  A total of 40 cases have been identified in 16 states, including one person in Illinois who was hospitalized.  

“Tens of thousands of people get sick every year in the U.S. from foodborne illnesses, and approximately 3,000 die," said IDPH Director Dr. Ngozi Ezike. “We will continue to work with state and national health officials to investigate this ongoing outbreak in an effort to prevent additional cases and potential deaths.”

The CDC is recommending people not eat romaine lettuce from the Salinas growing region in California. Additional information can be found on the CDC website.


Thanksgiving Turkey Safety Tips
As families look forward to their Thanksgiving meal this week, IDPH is offering tips to avoid foodborne illnesses.  Late last week, the Centers for Disease Control and Prevention reported 356 Salmonella Reading infections from 42 states (including Illinois) and the District of Columbia during 2017-19 linked to turkey.

“While most healthy people recover from foodborne illness, typically called food poisoning, in a day or two, others can suffer severe illness, including a condition where the kidneys stop working,” said IDPH Director Dr. Ngozi Ezike. “This holiday season, I recommend following several food safety steps to help prevent foodborne illness.” Those steps include safely thawing frozen turkeys, safely handling turkeys and properly cooking them.

More information on food safety during the holidays can be found on IDPH’s website as well as the Illinois Poison Center’s website.