Medical Innovation Exchange

device labeling

Abiomed Updates IFU for Impella Blood Pumps Due to Perforation Risks

Abiomed Updates IFU for Impella Blood Pumps Due to Perforation Risks     The FDA announced that Abiomed is updating the instructions for use (IFU) of its Impella Left Sided Blood Pumps because the pump catheter may perforate the wall of the left ventricle in the heart. During operations, the Impella device could cut through the …

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Why Human Factors Engineering Matters in Medical Device Packaging

Why Human Factors Engineering Matters in Medical Device Packaging     Human Factors Engineering (HFE), also referred to as Usability Engineering (UE), is the application of knowledge about human behavior, abilities, limitations and other characteristics of medical device users that are applied to the design of medical devices. These characteristics include mechanical and software-driven user interfaces, …

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Life Sciences Labeling for Patient Safety

Life Sciences Labeling for Patient Safety     Labeling regulations from the FDA and European Union (EU) are continuously changing to protect public health and improve patient safety. The Drug Supply Chain Security Act (DSCSA) enhances FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful. These …

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Device Labeling: Best Practices

Device Labeling: Best Practices     EU MDR required companies to make significant changes to their medical device labels, highlighting the need for a well-coordinated and agile device labeling process. We spoke with Laura Johnson, director of sales with Loftware, an enterprise labeling and artwork management provider, to discuss common pain points in label development and …

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