Sterile Solutions Supply Chain Disruption for Dialysis Treatment

 

To: All providers or those affected by the saline shortage From: Health Facilities and Emergency Medical Services Division URGENT ATTENTION REQUIRED - The Health Facilities and Emergency Medical Services Division needs assistance in updating information about who provides dialysis services at various facilities and the number of patients receiving dialysis at home. Hurricane Helene impacted one of the largest IV fluid suppliers, owned by Baxter International, in North Carolina. This has resulted in supply chain disruptions and gaps in supplies of normal saline IV fluids, irrigation fluids, sterile water, and certain dextrose solutions. Baxter has resumed shipping to hospitals and dialysis centers, and global plants are increasing production to meet U.S. needs. However, because of ongoing disruptions, some products remain on allocation. The division asks that you complete the Google Form linked below.  IF YOU OR SOMEONE IN YOUR FACILITY/AGENCY HAVE ALREADY COMPLETED THIS FORM YOU DO NOT NEED TO COMPLETE THE FORM AGAIN. The information in this form will help identify the number of patients receiving intravenous and peritoneal dialysis at various facilities and their locations. This form will also provide information on the number of patients receiving home dialysis for those facilities that provide home care services. Please include a reliable contact person and the facility or agency’s phone number.  Please complete this Google Form with the requested information.

Sterile Solutions Supply Chain Disruption by Peritoneal Dialysis

 

To: All providers or those affected by the saline shortage From: Health Facilities and Emergency Medical Services Division URGENT ATTENTION REQUIRED - The Health Facilities and Emergency Medical Services Division needs assistance in updating information about who provides dialysis services at various facilities and the number of patients receiving dialysis at home. Hurricane Helene impacted one of the largest IV fluid suppliers, owned by Baxter International, in North Carolina. This has resulted in supply chain disruptions and gaps in supplies of normal saline IV fluids, irrigation fluids, sterile water, and certain dextrose solutions. Baxter has resumed shipping to hospitals and dialysis centers, and global plants are increasing production to meet U.S. needs. However, because of ongoing disruptions, some products remain on allocation. The division asks that you complete the Google Form linked below.  IF YOU OR SOMEONE IN YOUR FACILITY/AGENCY HAVE ALREADY COMPLETED THIS FORM YOU DO NOT NEED TO COMPLETE THE FORM AGAIN. The information in this form will help identify the number of patients receiving intravenous and peritoneal dialysis at various facilities and their locations. This form will also provide information on the number of patients receiving home dialysis for those facilities that provide home care services. Please include a reliable contact person and the facility or agency’s phone number.  Please complete this Google Form with the requested information.

Sterile Solutions Supply Chain Disruption by Peritoneal Dialysis

 

To: All providers or those affected by the saline shortage From: Health Facilities and Emergency Medical Services Division URGENT ATTENTION REQUIRED - The Health Facilities and Emergency Medical Services Division needs assistance in updating information about who provides dialysis services at various facilities and the number of patients receiving dialysis at home. Hurricane Helene impacted one of the largest IV fluid suppliers, owned by Baxter International, in North Carolina. This has resulted in supply chain disruptions and gaps in supplies of normal saline IV fluids, irrigation fluids, sterile water, and certain dextrose solutions. Baxter has resumed shipping to hospitals and dialysis centers, and global plants are increasing production to meet U.S. needs. However, because of ongoing disruptions, some products remain on allocation. The division asks that you complete the Google Form linked below.  IF YOU OR SOMEONE IN YOUR FACILITY/AGENCY HAVE ALREADY COMPLETED THIS FORM YOU DO NOT NEED TO COMPLETE THE FORM AGAIN. The information in this form will help identify the number of patients receiving intravenous and peritoneal dialysis at various facilities and their locations. This form will also provide information on the number of patients receiving home dialysis for those facilities that provide home care services. Please include a reliable contact person and the facility or agency’s phone number.  Please complete this Google Form with the requested information.

Update on Saline and Sterile Solutions Supply Chain Disruptions

 

To: Home Health Agencies, Administrators, and OASIS Coordinators From The .To: All who may be affected by the saline shortage  From: HFEMSD We are reaching out with updates on the supply chain disruptions affecting saline and other sterile solutions due to Hurricane Helene. The recent storm impacted the Baxter facility in North Carolina, which supplies a significant portion of IV solutions and irrigation fluids across the U.S. This has led to a temporary shortage of normal saline IV fluids, irrigation fluids, sterile water, and certain dextrose solutions. Baxter has resumed shipping to hospitals and dialysis centers, and other global plants are scaling production to support U.S. needs. However, due to continued disruptions, certain products remain on allocation. Current and Upcoming Actions: Supply Coordination: HHS and ASPR are working with public and private partners to stabilize the supply chain, expedite FDA assessments of alternative products, and increase domestic manufacturing. Preparation for Further Storm Impact: With Hurricane Milton potentially affecting supply, assets are being pre-deployed, and production is being shifted from at-risk areas. Guidance for Providers: HHS encourages providers to: Evaluate and conserve supplies, prioritizing critical use cases. Review guidance from Baxter and ASHP on managing and conserving fluids effectively. Baxter is working directly with customers regarding allocations, and additional updates are available on their website. HHS will continue to coordinate with manufacturers and distributors and keep healthcare providers informed as this situation evolves. Baxter newsroom Hurricane Helene updates ASHP - fluid shortages suggestions for management and conservation Thank you for your patience and cooperation as we work through these supply chain challenges together. .

HEALTH ADVISORY ALERT: PREPARING FOR EXTREME HEAT THIS WEEKEND

 

To: Administrators and Managers of Nursing Homes, Assisted Living Residents and Group Homes/ICFs From: Peter Myers, Deputy Division Director, Health Facilities and Emergency Management Services Division Please review this newly released CDPHE health advisory alert on preparing for extreme heat this weekend. Please share this WIDELY with your staff. If you have any questions, please contact Melanie.Roth-Lawson@state.co.us or call 720-291-5929. .

New Course Available on COTrain: "Extreme Heat: Preparing Your Healthcare Residents, Patients, and Clients”

 

To: Administrators, Directors and Staff From:  Greg Schlosser, Branch Chief, Health Facility Education and Quality, Health Facilities & Emergency Services Division Re:   NEW FREE COURSE: "Extreme Heat: Preparing Your Healthcare Residents, Patients, and Clients” A new class, "Extreme Heat: Preparing Your Healthcare Residents, Patients, and Clients" is now live on COTrain. The course I.D. # is 1121335. We encourage you to share this class with your staff. Extreme heat events in Colorado are increasing in duration, frequency, and intensity as a result of climate change. And we’re seeing the repercussions of that on the health of communities that, unfortunately, are not used to the heat, or not set up to deal with the heat. These accelerating changes have led to a rise in human exposure to harmful temperatures. At the end of this module, you will understand: Extreme heat and its impact on our bodies;   Heat illness, persons most at risk, and other populations of concern; Steps to protecting your patients, residents, and clients from extreme heat; Monitoring your weather online using National Weather Service (NWS) resources. Components of an extreme heat emergency plan or annex. Always as a reminder, our complete offering of training opportunities for providers can be found at:  HFEMSD Provider Training Catalog For more information or if you have any questions, please reach out to Melanie Roth at 720-291-5929 or Melanie.Roth-Lawson@state.co.us. .

After Action Report on Power Outages on April

 

To: Administrators, Directors and Staff From:  Elaine McManis, Division Director, Health Facilities & Emergency Services Division Re:  After Action Report on the April 6th Xcel Power Outage in Six Counties On Saturday, April 6, Xcel Energy preemptively turned off 600 miles of power lines to reduce wildfire risk in six counties: Boulder, Broomfield, Douglas, Gilpin, Jefferson and Larimer. Xcel said that the proactive shutoffs affected about 55,000 customers. We understand that Xcel sent out voice messaging to impacted communities shortly before the outage, which many customers did not receive. As soon as we were notified about the intended shut-off, we alerted licensed healthcare providers via our provider messaging system. After power was restored, we heard from a number of providers that were frustrated with the lack of advance notification. We’d like to share the takeaways to ensure consistent services in the event that this happens again in the future:  Facilities are responsible to have individualized emergency plans for their clients, based on their individual needs. Encourage your clients that have DME to have extra batteries and/or a car charger available. Keeping extra concentrator batteries fully charged will give your clients oxygen for longer if you lose power. If possible, keep enough fully-charged batteries to last a couple of days. Talk with clients’ oxygen supply companies about a back-up emergency supply that does not require electricity such as oxygen tanks and cylinders. Make sure your clients know how to set up and use their back up emergency oxygen supply. If you have clients that rely on several different types of electrical assistive devices, he/she/they may want to look into purchasing a generator. Temporary use generators can be purchased at most hardware and department stores (such as Lowe’s, Home Depot, Sears, and similar stores) Some facilities did not receive our message until Monday morning: We use our provider messaging system to connect with the individual(s) listed as the COHFI account manager of our Colorado Health Facilities Interactive (COHFI) provider messaging system. We recommend that the COHFI account manager should be someone who can retrieve these messages seven days a week. We were unable to reach some providers we called: On Saturday, April 6, we received information from our Office of Emergency Preparedness and Response that there were a number of individuals calling their local EMS agencies because they had durable medical equipment, including oxygen concentrators that did not work without power.  We attempted to reach out to home health providers, but found that several were closed, and we had no alternate emergency contact information. We encourage healthcare providers to add that information into your COHFI account information under the field “alternate contact. We will explore technology options for sending out emergency messages via cell phones. Here are some resources that can help home health providers prepare their clients during emergencies: How to Survive an Extended Power Outage with Home Medical Equipment Home Use Devices: How to Prepare for and Handle Power Outages for Medical Devices that Require Electricity Emergency Power Planning for People Who Use Electricity and Battery-Dependent Assistive Technology and Medical Devices For residential providers, we’d like to remind everyone to have emergency plans in place if you cannot provide generator power and need to evacuate medically compromised residents. Finally, since all emergencies start locally, we want to make sure that you all have the appropriate local contact information, should you need to reach out for emergency assistance: Find your local emergency management contact information (and sign up for emergency alerts on this site) Find your regional health care coalition Find your local public health agency  For concerns related to the ability to care for residents, patients or clients, please reach out to Melanie Roth at 720-291-5929 or Melanie.Roth-Lawson@state.co.us. .

“Think Measles” resources from the CDC

 

Please see the following CDC guidance on measles and use the Project Firstline/AAP fact sheet at your facility to raise awareness among staff.   Healthcare professionals: Consider measles in any patient presenting with a febrile rash illness, especially if unvaccinated for measles or traveled internationally in the last 21 days.   Why this is important now: Declines in measles vaccination rates globally have increased the risk of larger measles outbreaks worldwide, including in the United States. Measles cases continue to be brought into the United States by travelers infected while in other countries. Most importations come from unvaccinated U.S. residents. When measles gets into communities of unvaccinated people in the U.S. outbreaks can occur. Outbreaks in countries to which Americans often travel can directly contribute to an increase in measles cases in the United States. In recent years, measles importations have come from frequently visited countries, including, but not limited to, the Philippines, Ukraine, Israel, Thailand, Vietnam, England, France, Germany, and India, where large outbreaks were reported.   Guidance for Healthcare Professionals: Diagnosing and Treating Measles | CDC Ensure all patients are up to date on MMR vaccine. Consider measles in patients with fever and rash and ask about recent international travel or exposure to international travelers or people with measles. Immediately notify local or state health departments about any suspected case of measles to ensure rapid testing and investigation. Promptly isolate: do not allow patients with suspected measles to remain in the waiting room or other common areas of the healthcare facility; isolate patients with suspected measles immediately, ideally in a single-patient airborne infection isolation room (AIIR) if available. In general, providers do not need to actively screen adult patients for measles immunity because of high population immunity and low risk of disease among adults in non-outbreak areas in the U.S. Before international travel, make sure your patients are protected against measles. Patients should be fully vaccinated at least 2 weeks before international departure: 1. Infants under 12 months old who are traveling can get an early dose at 6 through 11 months.  2. Children over 12 months old can get their first dose immediately and second dose 28 days after first dose. 3. Teens and adult with no evidence of immunity can get their first dose immediately and second dose 28 days after first dose. Adults who have presumptive evidence of immunity* include: Birth before 1957  Laboratory evidence of immunity (positive IgG) Prior laboratory confirmed measles diagnosis Adults without evidence of immunity generally should get one dose of MMR: Two doses are required/recommended for high-risk adults Healthcare personnel International travelers Postsecondary school students   * Apart from written documentation of age-appropriate vaccination For further information contact: cdphe_project_firstline@state.co.us .

Norovirus season 2023-2024

 

To: Colorado Long Term Care Facility Partners From: CDPHE’s Foodborne, Enteric, and Waterborne Disease Program Colorado is currently experiencing a higher than usual number of norovirus outbreaks. Between Sept. 1 - Dec. 22, 2023, 94 outbreaks caused by norovirus were reported, with 15 in long-term care facilities, 42 in schools, and 34 in child care facilities. While norovirus incidence is highest between the months of November to April, the number of outbreaks so far this season is more than this same time frame in previous years. 2019 – 81 outbreaks  2020 – Five outbreaks 2021 – 41 outbreaks 2022 – 47 outbreaks  Norovirus is highly contagious, and while it is often referred to as the “stomach flu,” it is not influenza. Norovirus sheds in the stool of people who are ill and spreads via fecal-oral route. Common symptoms include vomiting, diarrhea, nausea, and stomach pain. While less frequent, people who are ill can also experience fever, headache, and body aches. There is no treatment for norovirus. Due to the loss of fluids through vomiting and diarrhea, dehydration is a common complication of norovirus and can require hospitalization. Norovirus’ low infectious dose, high environmental stability, prolonged and profuse shedding, and potential for asymptomatic infection make it challenging to control. Outbreaks of any illness in any setting are immediately four (4) hours reportable to state or local public health per Colorado regulation 6 CCR 1009-1. Suspected and confirmed norovirus outbreaks can be reported to your local public health agency or CDPHE. Call 303-692-2700 or email  cdphe_food_enteric_water_diseases@state.co.us. You can prevent norovirus by:  Frequently washing your hands with soap and water for at least 20 seconds. Alcohol-based hand sanitizers are not effective against norovirus. This is especially important after using the toilet or changing diapers, before preparing or handling food, and prior to giving yourself or others medication. Not handling or preparing food for others when experiencing symptoms of norovirus, especially diarrhea.  Using a disinfectant that is effective against norovirus. A list of effective disinfectants can be found on EPA’s List G or a solution of one cup unscented household bleach mixed with10 cups of water can be used. This solution must remain wet on a surface for at least one minute to be effective.  Laundering soiled linens with detergent and hot water for the maximum available cycle length and machine drying on the highest heat setting.  Norovirus resources for prevention and guidance: CDPHE: Communications toolkit  CDC: Norovirus CDPHE: Norovirus bleach guidance  CDPHE: Outbreak report form - Long-term care facilities, health care facilities, and similar settings CDPHE: Guidelines for norovirus outbreaks in health care facilities For further information, please email: cdphe_food_enteric_water_diseases@state.co.us

Recall of Urology and Operating Room Kits

 

To: Infection Prevention Partners From:  CDPHE HAI/AR Program Dear IP Partners, We wanted to update you about an additional recall related to the Nurse Assist recall issued in November.   The U.S. Food and Drug Administration (FDA) issued a Safety Communication notifying that "Cardinal Health issued a medical device recall on December 5, 2023, for its Covidien and Cardinal Health™ brand urology and operating room-specific kits and trays that contain 0.9% sodium chloride irrigation USP and sterile water for irrigation USP supplied by Nurse Assist."   The Safety Communication provides a link to affected Covidien and Cardinal Health™ brand codes and lot numbers.   Please note:   Assure the timely and effective removal of these products according to the safety communication. Reports of adverse events associated with use of these recalled products can be transmitted via MedWatch. Notify CDPHE if you suspect a healthcare-associated infection or outbreak associated with recalled saline and sterile water products.    Please refer to the FDA Safety Communication for more details. To report an outbreak please email the CDPHE HAI/AR Program at cdphe_hai_ar@state.co.us or call the communicable disease line at 303-692-2700 (or 303-370-9395 after hours). For further information: Contact the CDPHE HAI/AR Program at cdphe_hai_ar@state.co.us .

Department of Human Services issues cybersecurity threat

 

To: Healthcare Providers From: Greg Schlosser, Branch Chief, Health Care Education and Quality, HFEMSD The Department of Health and Human Services’ (HHS) Health Sector Cybersecurity Coordination Center (HC3) is urging healthcare agencies and other critical infrastructure to take immediate action to patch and harden network systems against the ransomware threat “Citrix Bleed.” The vulnerability allows cyberthreat actors to bypass password requirements and multifactor authentication measures, to access private healthcare information. Read more. HC3 released a Sector Alert on November 30, 2023, which outlines patches, mitigations, and workarounds. Please review and share within your organization, as appropriate. We will forward any additional information we receive. For more information, contact Melanie.Roth-Lawson@state.co.us.

Utility Failure Resources

 

To: All stakeholders involved in the operations of Assisted Living Facilities in Colorado    From: HFEMSD     Utility failures are a major concern for health care and may cause substantial harm to patients, staff, and facilities. Threats include infrastructure damage due to natural disasters and other incidents, planned outages to relieve stress on services or prevent other hazards, and malicious acts such as physical and cyber sabotage. It is also important to note the cascading effects a failure of one utility may have on others; more than one utility may fail simultaneously or sequentially.   The Administration for Strategic Preparedness and Response (ASPR) from the US Department of Health and Human Services provides education to states regarding disaster preparedness. In the November 2023 edition of their newsletter, The Express, ASPR provides a Utility Failures in Health Care Tool Kit. This is valuable information in order to prepare for emergencies across the United States. This tool kit has resources available across the US.   Here is the Utility Failure Tool Kit.

Don’t Use Certain Brands of Saline and Sterile Water Medical Products by Nurse Assist Because They May Not Be Sterile

 

To: Healthcare Facilities, Agencies and Organizations From: Health Facilities and Emergency Medical Services Division The U.S. Food and Drug Administration (FDA) is warning consumers, health care providers, and health care facilities not to use recalled saline (0.9% sodium chloride) and sterile water medical products manufactured by Nurse Assist, LLC, and sold under various brands. On November 6, 2023, Nurse Assist, LLC announced a recall of the following water-based medical products because the products may not be sterile: 0.9% Sodium Chloride Irrigation USP (100 mL bottles, 250 mL bottles, 500 mL bottles, 1000 mL bottles, 3.1oz spray can, 7.1oz spray can, 3mL syringes, 5mL syringes, and 10mL syringes); Sterile Water for Irrigation USP (100 mL bottles, 250 mL bottles, 500 mL bottles, 1000 mL bottles, 120 mL cups, 10mL syringes, and 30mL syringes). These products were sold under the following brands: Nurse Assist, Cardinal, Covidien, Halyard Owens Minor, Idexx, Mac Medical, McKesson, Medichoice Owens Minor, Medline, Sol, SteriCare, Trudell, and Vyaire. The recalled products may be available as individual units or may be included as part of a kit. Recommendations for Consumers, Health Care Providers, and Facilities: Check your supply of saline (0.9% sodium chloride) and sterile water medical products (bottles, spray cans, cups, and prefilled syringes) to find out if you have any of the recalled products at home or in your health care facility’s inventory. Do not use these recalled products and follow the recommendations in the company’s recall announcement. Be aware that these recalled products may be available as individual units or may be included as part of a kit. If you have questions about this recall, contact Nurse Assist, LLC by phone at 800-649-6800 Monday through Friday between the hours of 8:00 am and 4:30 pm (CST) or by email at productremovalinfo@nurseassist.com.  Report any problems with saline and sterile water medical products by Nurse Assist, LLC to the FDA. See Reporting Problems to the FDA. For a complete list of affected products and more details, visit the U.S. Food and Drug Administration information release.