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UDI to Cost Savings and Quality of Care Improvement
Consider the historical path of the Unique Device Identifier (UDI) currently hovering at its real-time usage and the resulting in cost savings and patient safety improvements.
Exela sodium bicarbonate injection recalled due to potential for flying glass
Exela Pharma Sciences this week recalled 49 lots of sodium bicarbonate injection because the vial may break while preparing the product for administration, causing glass to fly.
FDA alerts providers to breathing device mask recall
Philips Respironics has recalled more than 17 million masks used with Bilevel Positive Airway Pressure and Continuous Positive Airway Pressure machines because the masks contain magnets that could cause serious injury to people with implanted metallic medical devices or other objects, the Food and Drug Administration announced yesterday. Philips has reported 14 serious injuries related to using the masks, including pacemaker failure, arrhythmia, seizures and irregular blood pressure. BPAP and CPAP machines are used by people with obstructive sleep apnea, respiratory insufficiency or respiratory failure — health conditions that cause breathing pauses during sleep.
FDA announces serious medical device recall
The FDA announced a Class 1 recall of devices used to access blood vessels through a patient’s bone because the devices may malfunction, and recommended customers quarantine the devices.
Agencies issue update on ethylene oxide risk from commercial sterilizers
The Environmental Protection Agency released a list of commercial medical device sterilizing facilities where lifetime risk from ethylene oxide emissions are highest to people who live nearby.
Baxter recalls software that may mislabel compounded drugs
Baxter Healthcare Corp. recently recalled its Abacus software for ordering compounded liquid medications due to a risk the printed bag labels may contain incorrect information, the FDA announced.
Recalled infusion pumps may cause serious injury
Smiths Medical recently recalled more than 118,000 Medfusion syringe infusion pumps whose software could malfunction, the FDA announced.
CVS, Walgreens Take On Clinical Trials to Improve the Patient Experience
CVS Health and Walgreens recently launched clinical trials businesses with an eye toward reducing research costs and making it easier for historically underrepresented racial and ethnic groups to participate in drug and medical device studies.
FDA issues update on heart device recall
The FDA released an update on Medtronic’s recall of 1,614 devices used to pump blood from the heart to the rest of the body
House passes bill to reauthorize FDA user fee programs
The House voted to pass legislation that would reauthorize FDA user fee programs.