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FDA Warns Hamilton G5 Ventilator May Stop Functioning without Sounding Alarm

Filed November 16th, 2015 Fran Kelley

The Food and Drug Administration (FDA) has issued a safety announcement in connection with the recall of the Hamilton G5 ventilator.

The ventilator, now under Class 1 recall, may stop working without sounding an alarm when the operator presses the oxygen enrichment key to attach the ventilator mask to the patient (suctioning maneuver), the FDA warns. This problem can occur under the following conditions: Continue Reading »

FDA Issues Another Class I Recall for Hamilton Medical Ventilators

Filed November 11th, 2015 Lillian Chiu

The U.S. Food and Drug Administration (FDA) has placed put its most serious recall status on a recall of Hamilton Medical ventilators. According to an agency recall notice, Hamilton-G5 ventilators may inadvertently suppress ventilation alarms when the operator activates a suctioning maneuver. This defect may occur regardless of whether the system is being used on a neonatal, pediatric or adult patient, the FDA notice states. About 1,126 machines in the US are affected by the recall, which applies to software versions between V2.00 and 2.31. Customers were first notified about the recall in April, but the FDA only announced the recall this week, Fierce Medical Devices reports.

A Class I designation indicates that exposure to the recalled device presents a reasonable risk of serious injury or death; it is the FDA’s most serious recall status. Continue Reading »

Four Deaths at Pennsylvania Hospital Linked to Infection from Heart Surgery Device

Filed November 2nd, 2015 Fran Kelley

As many as 1300 patients at WellSpan York Hospital in York, Pennylvania may have been exposed to bacteria known as nontuberculous mycobacterium during open-heart surgeries performed between October 1, 2011 to July 24, 2015.

A medical device—a heater-cooler system, which is used to heat or cool blood during heart surgery, was believed to have spread infections to at least some of these patients, Qmed reports. Continue Reading »

Members of Congress Call for Revocation of Approval for Essure Birth Control System

Filed October 20th, 2015 Fran Kelley

Pennsylvania Congressman Mike Fitzpatrick plans to introduce legislation to revoke the premarket approval the Essure birth control system received from the Food and Drug Administration (FDA) in 2002.

If passed, the bill calls for withdrawing the approval within 60 days, ABC station WRIC in Richmond, Virginia reports. Rep. Fitzpatrick plans to introduce the bill in the next few weeks. Continue Reading »

Studies Show Reduced Leaflet Motion in Bioprosthetic Aortic Valves, Prompting FDA Safety Alert

Filed October 7th, 2015 Fran Kelley

The Food and Drug Administration (FDA) has responded to evidence of reduced leaflet motion in bioprosthetic aortic valves with a safety alert acknowledging the possibility that patients receiving bioprosthetic valves may be at higher risk for stroke than has previously been recognized.

Though the FDA says it believes that bioprosthetic aortic valves remain reasonably safe and effective when used according to their approved indications, the agency is working with the American College of Cardiology, the Society of Thoracic Surgeons, and the device manufacturers to design clinical studies to fully evaluate reduced valve leaflet motion for all types of bioprosthetic aortic valves. Continue Reading »

FDA Expert Panel Calls for Changes in Patient Selection and Monitoring with Essure Birth Control System

Filed September 30th, 2015 Fran Kelley

Members of a Food and Drug Administration (FDA) expert panel have called for changes in the use and monitoring of the Essure permanent birth control system.

At a September 24th meeting at the FDA’s Maryland campus, the agency’s Obstetrics and Gynecology Devices panel reviewed post-marketing data, peer-reviewed studies, and hours of patient comments about the Essure device, before offering recommendations to the agency for best practices, stronger patient education, and increased collection of data, Medpage Today reports. Continue Reading »

Safety of Essure Birth Control to be Subject of FDA Obstetrics and Gynecology Panel

Filed September 23rd, 2015 Fran Kelley

On Thursday, September 24, the Food and Drug Administration’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will meet to discuss the risks and benefits of Bayer HealthCare Pharmaceutical’s Essure birth control system.

The expert panel will consider problems reported with the Essure. Women who have been implanted with the device report chronic pain, bleeding, headaches, and allergic reactions, among other symptoms, according to US News and World Report. Continue Reading »

FDA Warns that Bronchoscopes May Spread Infection

Filed September 21st, 2015 Lillian Chiu

Following several superbug outbreaks linked to contaminated gastrointestinal scopes, the U.S. Food and Drug Administration (FDA) is warning that another type of scope may carry the same risks. On Thursday, the agency said that bronchoscopes, which are used to diagnose and treat airway conditions, can cause infections even if the devices are cleaned according to manufacturer’s instructions.

The FDA “has undertaken an ongoing, comprehensive investigation into infections associated with reprocessed reusable medical devices, working with federal partners, manufacturers, and other stakeholders to better understand the critical factors contributing to device-associated patient infection and how to best mitigate them.” So far, no deaths have been linked to tainted bronchoscopes. The agency evaluated 109 reports of bronchoscope-related infections it received from January 2010 to June 2015. The FDA said fifty of the reports were filed last year alone. Scope maker Olympus Corp. told the FDA in December that one of its bronchoscopes possibly infected 14 patients with the antibiotic-resistant CRE. Continue Reading »

Thoratec Issues Recall for HeartMate II LVAS After Two Patients Die When Trying to Switch Controllers

Filed September 17th, 2015 Fran Kelley

Two patients implanted with the Thoratec HeartMateII LVAS (left ventricular assist system), responding to a backup battery expiration alarm, died trying to switch device controller. These deaths, and another patient’s injury, prompted Thoratec to send an Urgent Medical Device Correction Letter to hospitals with patients with HeartMate II devices.

A left ventricular assist device is a pump implanted to help circulate blood when the patient’s heart is too weak to circulate blood on its own. LVAS devices are implanted in patients with severe heart failure who are waiting for heart transplants. Continue Reading »

Despite Reports of Injuries and Deaths, C.R. Bard Continued to Market Recovery IVC Filter

Filed September 9th, 2015 Fran Kelley

Despite reports of serious injuries and deaths, C.R. Bard continued to market its Inferior Vena Cava (IVC) filters.

NBC Nightly News conducted a yearlong investigation of the IVC filters and found that the Bard filters failed and caused significant injuries and deaths at a considerably higher rate than that of  similar devices.

The Bard IVC filter is implanted in the inferior vena cava, the large vein that carries blood from the lower body back to the heart. The small, cone-shaped device is intended to prevent a blood clot from reaching the patient’s heart or lungs, according to NBC News. Approximately 250,000 IVC filters are implanted annually. Continue Reading »

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