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Keep current with regulatory changes from more than a dozen federal regulatory bodies, including TJC & NIAHO
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Helpful MCN Healthcare Resources
Class I Recall - GE Healthcare, LLC - Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC)
A recall has been issued for the GE Healthcare, LLC, Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC). The affected CO2 detectors may fail or provide incorrect CO2 values for mechanically and spontaneous ventilated patients.
- Manufacturing Dates: February 10, 2012 through October 2, 2012
- Distribution Dates: February 2012 to April 2014
- Affected Product Details:
- Single-Width Airway Modules (E-miniC) -Serial Numbers 6818561 through 6898777.
- The Extension Modules N-FC and N-FCREC - Serial Numbers 6799191 through 6905206.
- The serial number can be found on the device plate attached to the module.
There have no reports of injuries or deaths assocated with the malfunctioned devices to date.
On June 11, 2014, the firm sent an Urgent Medical Devise Correction Letter (see below under Resources) to their customers. The letter identified the affected products, problem and provided safety instructions. Customers should read the letter and follow the instructions provided.
For questions about this Recall, customers may contact GE Healthcare Technical Support at 1-800-558-7044, Monday - Friday, 8:00 am - 5:00 pm, Central Time or the local service representative.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Informatin and Adverse Event Reporting Program either online, by regular mail or by FAX.
The Society for Healthcare Epidemiology of America has issued updated guidance for preventing central line-associated blood stream infections in hospitals. Published in the July Issue of Infection Control and Hospital Epidemiology, the guidance updates the 2008 "Strategies to Prevent Healthcare-Associated Infections in Acute Care Hospitals."
The purpose of the guidance document is to provide hospitals with practical recommendations for implementing and prioritizing central line-associated bloodstream infection (CLABSI) prevention efforts. The recommendations in the guidance focus on central venous catheters (CVCs) and therefore the recommendations may not be effective for preventing bloodstream infections related to other intravascular devices. The guidance reviews both basic recommendations that should be adopted by all acute care hospitals and also specific practices that can be considered when CLABSIs are not controlled by the basic recommendations.
Today's StayAlert! Notice reviews the basic recommendations. Please review the article for the Special Approaches for preventing CLABSI recommendations. Basic recommendations include:
- Have an evidence-based list of indications for CVC's readily available
- Require education for healthcare personnel involved in the insertion, care and maintenance of CVCs. Education should include CLABSI prevention strategies.
- Ensure that any healthcare professional who inserts a CVC undergoes a credentialing process (as established by the individual healthcare organization) to ensure their competency before independently inserting a CVC.
- Bathe all ICU patients over two (2) months of age with a chlorhexidine preparation on a daily basis
- Processes should be in place to ensure infection prevention strategies are adhered to at the time of CVC insertion, i.e., a checklist
- Hand hygiene must be performed prior to catheter insertion
- When possible do not use the femoral vein for CVC access in obese adult patients
- When possible utilize an all-inclusive catheter kit/cart
- Utilize ultrasound guidance for the insertion of internal jugular catheters
- Use maximum sterile barrier precautions during CVC insertion
- Use an alcoholic chlorhexidine antiseptic for skin preparation
- Ensure appropriate staffing and limit use of float nurses in ICUs
- Disinfect catheter hubs, needleless connectors, and injection ports before accessing the CVC
- Remove all non- essential catheters as soon as possible
- For non-tunneled CVCs in adults and children, change transparent dressings and perform site care with a chlorhexidine-based antiseptic every 5-7 days or immediately if the dressing is soiled, loose, or damp; change gauze dressings every 2 days or earlier if the dressing is soiled, loose, or damp
- Replace administration sets not used for blood, blood products, or lipids at intervals not longer than 96 hours
- Use antimicrobial ointments for hemodialysis catheter-insertion sites
- Perform surveillance for CLABSI in ICU and non-ICU settings
The Guidance also addresses approaches that should not be considered routine for the prevention of CLABS i.e., systemic antimicrobial prophylaxis and routine catheter replacement are not recommended
Joint Commission National Patient Safety Goal (NPSG.07.04.01) requires hospitals to implement strategies to reduce central line associated blood stream infections. Guidance such as this update from SHEA is a valuable tool for hospitals as they seek to prevent and decrease CLABSI and meet JTC requirements.
As reviewed by StayAlert! on June 10, 2014, the Centers for Medicare & Medicaid Services (CMS) revised the Conditions for Coverage (CfC) for Ambulatory Surgical Centers (ASCs) regarding radiological services [§416.49(b)(2)] effective July 2014.
- Radiologic services may only be provided when integral to procedures offered by the ASC and must meet the requirements specified in §482.26(b), (c)(2), and (d)(2).
- §482.26(b) Standard: Safety for Patients and Personnel- The radiologic services, particularly ionizing radiology procedures, must be free from hazards for patients and personnel.
- §482.26(c)(2) - Only personnel designated as qualified by the medical staff may use the radiologic equipment and administer procedures.
- §482.26(d)(2) - The hospital must maintain the following for at least 5 years:(i) Copies of reports and printouts; (ii) Films, scans, and other image records, as appropriate.
- If radiologic services are utilized by an Ambulatory Surgical Center, the governing body shall appoint an individual qualified in accordance with State law and ASC policies who is responsible for assuring that all radiologic services are provided in accordance with the requirements of section §416.49(b)
In response to CMS changes, The Joint Commission has revised its requirements for ASCs that elect to use The Joint Commission deemed status option, effective immediately. Please see the Prepublication Requirements at the link below.
Featured Policy Library Manuals
MCN's NEW Ambulatory Surgical Center/Outpatient Surgery Department Policy and Procedure Manual is cross referenced to TJC standards, AAAHC standards and CMS regulations. Policies and procedures meet AORN and CDC recommendations and guidelines. This comprehensive reference guide has over 290 policies and procedures that are ready to customize to your organization. See also the Administrative Manual for Ambulatory Care Facilities and the Ambulatory Services EOC Manual.Read more »
MCN's Central Service Policy and Procedure Manual provides over 200 proven, up-to-date policies and procedures in a ready-to-customize format. This manual is cross referenced to federal regulations, as well as Joint Commission and NIAHO standards. References used include AAMI Recommended Practices, IAHCSMM Central Service Technical Manual, ASHCSP Training Manual for Health Care Central Service Technicians and AORN Recommended Practices.Read more »
MCN's Post Anesthesia Care Policy and Procedure Manual is a comprehensive resource that covers the latest "hot topic" regulatory and patient safety issues that are relevant to PACU! This manual includes administrative, operational, functional and patient-centered policies and procedures. Policies and procedures are cross-referenced to CMS regulations, Joint Commission standards and NIAHO standards.Read more »