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Medicare

CMS Changes in Reimbursement for ECMO Procedures

The Centers for Medicare and Medicaid Services (CMS) implemented changes for ECMO procedures in the Medical Severity-Diagnosis Related Group (MS-DRG) on October 1, 2018.

Hydrogen Peroxide Monitoring and Design Upgrade Customer Letter

Hydrogen Peroxide Monitoring and Design Upgrade Customer Letter

The purpose of this letter is to advise you that LivaNova Deutschland GmbH (“LivaNova” or “the Company”) is executing a voluntary medical device correction for the 3T Heater-Cooler Systems (“3T”). This letter describes immediate action to be taken by you.

FIELD SAFETY NOTICE UPDATE Cardiac Surgery Mycobacterium Risks Disinfection and Cleaning of Sorin Heater Cooler Devices

FIELD SAFETY NOTICE UPDATE Cardiac Surgery Mycobacterium Risks Disinfection and Cleaning of Sorin Heater Cooler Devices

Attention: Hygiene Specialists, Cardiac Surgery Operating Room Responsible, Risk/ Safety Managers, Distributors, Clinicians, Perfusionists and other users of these devices

Reemergence of Mycobacterium chimaera in Heater–Cooler Units despite Intensified Cleaning and Disinfection Protocol

Reemergence of Mycobacterium chimaera in Heater–Cooler Units despite Intensified Cleaning and Disinfection Protocol

Invasive Mycobacterium chimaera infections after open-heart surgery have been reported internationally.

Quest Medical, Inc. Issues Recall of MPS® Delivery Set

Quest Medical, Inc. Issues Recall of MPS® Delivery Set

On October 28, 2015, Quest Medical, Inc. initiated a nationwide recall of Myocardial Protection System (MPS) Delivery Sets, Models 5001102, 5001102-AS, and 7001102 of specified lots. The product(s) have been found to intermittently exhibit a seal failure during use, which potentially could result in patient blood loss.

Platelet Rich Plasma and Knee Surgery

Platelet Rich Plasma and Knee Surgery

In the last fifteen years, the field of regenerative medicine is witnessing a boost of autologous blood-derived platelet rich plasma products (PRPs) application to effectively mimic and accelerate the tissue healing process.

Maquet Medical Systems, Tiger Paw System II – May Cause Tears and Bleeding in Heart Tissue

Maquet Medical Systems, Tiger Paw System II – May Cause Tears and Bleeding in Heart Tissue

The reason for recall is the incomplete closure of the TigerPaw System II may result in tissue tears and/or bleeding. The
use of this recalled device may cause serious adverse health consequences, including death.

Use of Bone Graft Substitutes Containing Recombinant Proteins  or Synthetic Peptides in Patients under Age 18

Use of Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients under Age 18

Use of Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients under Age 18

Fatal Air Embolism during Cardiopulmonary Bypass: Analysis of an Incident and Prevention Measures

Fatal Air Embolism during Cardiopulmonary Bypass: Analysis of an Incident and Prevention Measures

We present a case of a patient who suffered an air embolism

A Cluster of Mycobacterium wolinskyi Surgical Site Infections at an Academic Medical Center

A Cluster of Mycobacterium wolinskyi Surgical Site Infections at an Academic Medical Center

Observational investigation revealed a cold-air blaster exclusive to operating room A as well a microbially contaminated, self-contained water source used in heart-lung machines

Datascope Corp/MAQUET Issues Worldwide Voluntary Recall of the System

Datascope Corp/MAQUET Issues Worldwide Voluntary Recall of the System

IABP brand names for a potential mechanical failure of the fan assembly associated with the power supply.

Thoratec Corporation Issues Worldwide Urgent Medical Device Correction  Letter to Update its Labeling Regarding the Use of the HeartMate II® LVAS  Pocket System Controller

Thoratec Corporation Issues Worldwide Urgent Medical Device Correction Letter to Update its Labeling Regarding the Use of the HeartMate II® LVAS Pocket System Controller

This safety advisory is being issued because some patients and caregivers have experienced difficulties with the process of changing from a primary system controller to their backup system controller.

Update: IV Fluid Shortage

Update: IV Fluid Shortage

FDA is aware of the shortage situation for intravenous (IV) solutions, particularly 0.9% sodium chloride injection (i.e., saline)

Calcium gluconate 10 percent Injections by Rx Formulations: Recall – Microbial Contamination

Calcium gluconate 10 percent Injections by Rx Formulations: Recall – Microbial Contamination

FDA notified healthcare professionals to follow up with patients who received calcium gluconate 10% injections made by Rx Formulations, Mesa, Ariz., between Nov. 7 and Dec. 11, 2013.

Medical Device Safety Alert: Edwards Lifesciences Femoral Arterial and Venous Cannula

Medical Device Safety Alert: Edwards Lifesciences Femoral Arterial and Venous Cannula

Edwards Lifesciences has identified an increase in the use of our Femoral Arterial and Venous Cannula in adult and pediatric populations in a manner that is not intended

Shortage: Sodium Chloride 0.9% Injection Bags

Shortage: Sodium Chloride 0.9% Injection Bags

Shortage: Sodium Chloride 0.9% Injection Bags

Shortage: Norepinephrine Injection

Shortage: Norepinephrine Injection

Norepinephrine Injection

Baxter Initiates Worldwide Voluntary Recall Of Select Lots Of 5 percent Dextrose Injection, USP And 0.9 percent Sodium Chloride Injection, USP Intravenous (IV) Solutions

Baxter Initiates Worldwide Voluntary Recall Of Select Lots Of 5 percent Dextrose Injection, USP And 0.9 percent Sodium Chloride Injection, USP Intravenous (IV) Solutions

Baxter International Inc. announced today it has initiated a voluntary recall to the hospital/user level of one lot of 5 percent Dextrose Injection, USP and four lots of 0.9 percent Sodium Chloride Injection, USP due to particulate matter found in the solutions. Injecting a product containing particulate matter may result in blockages of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver.

Hospira Issues a Voluntary Nationwide Recall of One Lot of Lidocaine HCl Injection, USP, 2%, 5 Ml in 5 Ml Vial, Due to Presence of Particulate Matter

Hospira Issues a Voluntary Nationwide Recall of One Lot of Lidocaine HCl Injection, USP, 2%, 5 Ml in 5 Ml Vial, Due to Presence of Particulate Matter

Lidocaine HCl Injection 2%, 5 ml Vial by Hospira: Recall – Presence of Particulate Matter

Postmarket Surveillance of Medical Devices: Current Capabilities and Future Opportunities

Postmarket Surveillance of Medical Devices: Current Capabilities and Future Opportunities

Recalls of cardiac implantable electrical devices (CIEDs) currently impact hundreds of thousands of patients worldwide.

FDA Regulation of Cardiovascular Devices and Opportunities for Improvement

FDA Regulation of Cardiovascular Devices and Opportunities for Improvement

This article reviews FDA regulation of cardiovascular devices and offers suggestions for strengthening the process while focusing on examples relevant to cardiac electrophysiologists.

Medical Device Safety and Recalls: Rare Serious Erosion Events Associated with St. Jude Amplatzer Atrial Septal Occluder (ASO)

Medical Device Safety and Recalls: Rare Serious Erosion Events Associated with St. Jude Amplatzer Atrial Septal Occluder (ASO)

FDA is alerting health care providers and patients that in very rare instances, tissue surrounding the Amplatzer ASO can break down (erode) and result in life-threatening emergencies that require immediate surgery.

Survey of Methods Used to Detect Bacterial Contamination of Platelet Products in the United States in 2011

Survey of Methods Used to Detect Bacterial Contamination of Platelet Products in the United States in 2011

An Internet-based survey of AABB member institutions was conducted from May to June 2012, to document current practices used in 2011 for bacterial detection in different PLT products and to assess the impact of the new standard.

Blood Component Recalls and Market Withdrawals: Frequency, Reasons, and Management in the United States

Blood Component Recalls and Market Withdrawals: Frequency, Reasons, and Management in the United States

The U.S. Food and Drug Administration has issued several recent guidances that address transfusion service actions for dealing with specific infectious disease problems. This present article updates our 2004 recommendations as to when to notify physicians about transfused nonconforming blood components.