IHA Daily Briefing: May 10

In Today’s Issue
IHA Invites Nursing Leaders to Join Upcoming Committee Meetings
Illinois Hospital Report Card Preview Resources, Updates
FDA Cautions Healthcare Providers Against Using Getinge Heart Devices
Final Guidance on ‘Remanufacturing’ Devices Needing Maintenance, Repair
COVID-19 Information 
Briefly Noted
Leading the News


IHA Invites Nursing Leaders to Join Upcoming Committee Meetings
As we continue to celebrate Illinois nurses and their invaluable contributions during National Nurses Week, IHA is inviting nursing leaders and their nursing care committee co-chairs to participate in the Nursing Care Committee Co-Chair Forum.  

This forum meets regularly to highlight the background and requirements of the Nurse Staffing Improvement Act, discuss resources available to support hospitals with implementing the requirements, and inspire you to ensure that your Nursing Care Committee thrives and lives up to its potential.  

We invite the nursing leaders and committee co-chairs in your organization to register and participate in our upcoming meetings. We also encourage you to share the registration information with others in your organization who lead your nursing care committee’s efforts. 

IHA would like to thank you for your dedication and support of nurses across the state. If you have any questions, please reach out to NurseStaffing@team-iha.org.     


Illinois Hospital Report Card Preview Resources, Updates
On April 16, the Illinois Dept. of Public Health (IDPH) sent a notice to hospital and ambulatory surgical center administrators with notification of the hospital report card preview period that will open on May 20. 

On April 29, IDPH hosted a webinar focused on the Illinois Hospital Report Card website update and steps hospitals can take to preview their publicly reported data. You will find the slides from the presentation and answers to questions posed during the webinar. The webinar recording can also be accessed by clicking here.

If the appropriate individuals in your facility are not receiving information about the hospital report card, please update your facility’s contact information using this excel file, and return that file to DPH.HRCPreview@Illinois.gov

If you have any questions about the process for reviewing or accessing your organization’s report card preview data please reach out to IDPH at DPH.HRCPreview@Illinois.gov

Contact us with questions.


 FDA Cautions Healthcare Providers Against Using Getinge Heart Devices
A May 8 letter to healthcare providers issued by the Food and Drug Administration (FDA) highlighted safety and quality concerns with Getinge/Maquet cardiovascular medical devices, including Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump  devices and Getinge/Maquet Cardiohelp system and HLS Sets.

The FDA alert said it “recommends that health care facilities transition away from use of these devices and seek alternatives, if possible. These recommendations are based on our continued concerns that Getinge/Maquet has not sufficiently addressed the problems and risks with these recalled devices.” Acknowledging alternative treatment options are limited, the letter highlights recommendations for healthcare providers when these devices are use. 

The company has issued 12 recalls for its Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump since 2023, and eight recalls for its Cardiohelp System and HLS sets since last year. The FDA has received 33 reports of serious injury or death tied to the CardioHelp life support system and 15 reports linked to the balloon pump over the last year.


Final Guidance on ‘Remanufacturing’ Devices Needing Maintenance, Repair
Yesterday, the Food and Drug Administration issued final guidance to provide the medical device industry clarity on the definition of “remanufacturing” for reusable devices needing maintenance or repair. The final guidance was issued following the agency’s review of postmarket information and consideration of public comments. 

The FDA advised in the guidance that devices include instructions necessary for proper device servicing, and provide examples of activities that constitute remanufacturing. The guidance defines remanufacturing as “the processing, conditioning, renovating, repackaging, restoring or any other act done to a finished device that significantly changes the finished device’s performance, safety specifications or intended use.” Additionally, the guidance recommends certain information be included in the labeling of reusable medical devices regarding their preventive maintenance and repair, including instructions on how to adequately return a device to its performance and safety specifications established by the original equipment manufacturer.

Many medical devices are reused—for instance, infant warmers, ventilators, endoscopes and defibrillators—and proper servicing is critical to the device’s continued performance and overall total product lifecycle. Additionally, many devices are complex and use varying technologies to be safe and effective for their intended use. Without access to information and resources to ensure proper servicing, unintentional remanufacturing, which may cause the device to be out of compliance with and in violation of federal law, can occur. 


COVID-19 Information
The Illinois Dept. of Public Health (IDPH) has launched a weekly Infectious Respiratory Disease Surveillance Dashboard that will be updated weekly on Friday. This report provides the public with the latest data on hospital visits, seasonal trends, lab test positivity and demographic data. 

Click here to visit the IDPH COVID-19 resources webpage. IDPH will continue to report the weekly number of people with COVID-19 admitted to hospitals from emergency departments, deaths and vaccinations, with COVID-19, influenza and respiratory syncytial virus information also reported through the dashboard of the Illinois Wastewater Surveillance System.


Briefly Noted
The American Cancer Society this week announced it is seeking participants for what may be the largest national study seeking to understand why Black women have the highest death rate in the U.S. of any racial or ethnic group for most cancers. Enrollment for the Voices of Black Women study opened on May 6 in 20 states, including Illinois, and the District of Columbia. The organization chose these states because 90% of Black women between 25 and 55 live there. The study hopes to recruit at least 100,000 Black women to follow for 30 years. 


Leading the News

Search the database to find Illinois hospitals and their ratings
Chicago Tribune reported (5/10) that, “A number of organizations release ratings for U.S. hospitals each year to help patients make decisions about where to receive care. Each organization assesses hospitals using its own methodology, meaning a facility rated highly by one may carry a lower score with another. To help readers easily weigh these valuations across hospitals, the Tribune created the searchable database below using reports from three prominent sources: U.S. News & World Report, the Leapfrog Group and Medicare.gov.”

168 top maternity hospitals, state by state
Becker’s Hospital Review reported (5/9) that, “Newsweek has released its third annual list of best maternity hospitals in the U.S., and 404 hospitals made the ranking.” 

The 28 rural emergency hospitals, by state
Becker’s Hospital Review reported (5/9) that, “Twenty-eight hospitals have converted to the rural emergency designation since the law that created the designation took effect in January 2023, according to data from CMS.”