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Everything your healthcare organization needs to confidently maintain accreditation compliance.
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Simplify & automate policy access, review and approval across your organization
Web-based library of more than 18,000 customizable policy documents
Instantly access up-to-date policies, procedures & forms authored by MCN experts
Automated regulatory notification system of daily email or mobile alerts
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 of Certain Abbott Diabetes Care, Inc. FreeStyle and FreeStyle Flash Blood Glucose Meters
Abbott Diabetes Care has identified that certain glucose meters have the potential to produce erroneously low blood glucose results when used in conjunction with certain Free Style test strips. This issue occurs with FreeStyle, FreeStyle Flash Blood Glucose meters and the FreeStyle blood glucose meter built into the OmniPod Insulin Management System. Affected meters and test strips have been identified by Abbott and customer notification letters with specific instructions for each product have been issued. The use of affected product may cause serious adverse health consequences, including death.
The affected products are the FreeStyle and FreeStyle Flash Blood Glucose Meters, including the FreeStyle Blood Glucose Meter built into the OmniPod Personal Diabetes Manager (PDM). FreeStyle and FreeStyle Flash Blood Glucose Meters are intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. Additionally, the OmniPod Personal Diabetes Manager system contains an integrated FreeStyle meter.
Abbott Diabetes Care is requesting users of the FreeStyle and FreeStyle Flash Blood Glucose Meters to discontinue use of these meters and to call Abbott for a new unaffected meter.
Users of the FreeStyle Blood Glucose Meter built into the OmniPod Personal Diabetes Manager are requested to discontinue use of affected test strips and to call Abbott for replacement unaffected test strips.
Please see the recall notice for specific and detailed information about steps to take for each affected product.
Covidien Implements Voluntary Recall of its Pipeline Embolization Device and Alligator Retrieval Device
Covidien is informing healthcare professionals of a voluntary recall to address an issue with certain lots of its PipelineTM Embolization Device and AlligatorTM Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate and detach from the devices. PTFE coating is used to reduce friction between devices and ease navigation through the vasculature. Delamination of the PTFE coating could potentially lead to embolic occlusion in the cerebral vasculature with the risk of stroke and/or death.
Covidien learned of this issue through internal product testing. The company has not received any reports of patient injuries to date related to this issue.
The PipelineTM Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wideâ€necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments. The Alligator Retrieval Device is intended for use in the peripheral and neuroâ€vasculature for foreign body retrieval.
A total of 32 Pipeline Embolization Devices and 621 Alligator Retrieval Devices are affected by this recall. The products were manufactured and distributed from May 2013 to March 2014. This issue involves both the Pipeline Embolization Device sold in the U.S., Australia, France, Germany and United Kingdom, and the Alligator Retrieval Device, which is sold in the U.S., Australia, Canada, Europe and Latin America.
Covidien alerted customers to the recall by letter on April 1, 2014, and is arranging for replacement of the recalled products. The U.S. Food and Drug Administration (FDA) and other regulatory bodies also have been notified.
USPSTF Draft Recommendation Statement on the Use of Low-Dose Aspirin for the Prevention of Morbidity and Mortality from Preeclampsia
The United States Preventative Services Task Force (USPSTF) has published a draft recommendation on the use of low-dose aspirin for the prevention of morbidity and mortality from preeclampsia. Based on an evidence review that was published on April 8, 2014 USPSTF recommends low-dose aspirin (81 mg/day) preventive medication after 12 weeks gestation in women who are at high risk for preeclampsia.
The USPSTF makes recommendations about the effectiveness of specific preventive care services for patients without related signs or symptoms. It bases its recommendations on the evidence of both the benefits and harms of the service, and an assessment of the balance. The USPSTF does not consider the costs of providing a service in this assessment. The USPSTF recognizes that clinical decisions involve more considerations than evidence alone. Clinicians should understand the evidence but individualize decision making to the specific patient or situation. Similarly, the USPSTF notes that policy and coverage decisions involve considerations in addition to the evidence of clinical benefits and harms.
The draft recommendation statement is available for comment until May 5, 2014. Follow the link below to read the entire recommendation statement and for comment submission instructions.
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 »