Material Changes for FDA Regulated Medical Devices

Changes in formulations of materials used for manufacturing patient-contacting medical devices or device components often require submission of a new 510(k) by the device manufacturer.  This is because formulation changes can affect the biocompatibility, material properties and performance of a device. The FDA defines material formulation changes to include the following: – Changes to the chemical composition […]

PVC Remains Relevant in Medical Devices

Polyvinyl chloride (PVC) represents as much as one-third of the volume of polymers used in the manufacture of medical devices.  Common device applications for PVC include intravenous (IV) tubing and blood bags.  Environmental and health advocates have expressed concerns for years regarding the use of the polymer in medical applications, and the FDA issued an […]

Medical Plastics That Reduce Hospital Infections

One out of every 25 patients in U.S. acute care hospitals contract a health care associated infection, according to a survey by the Center for Disease Control (CDC).  One in every four of these are associated with medical devices. In-dwelling devices, such as central venous (CV) catheters, are particularly susceptible to bacteria colonization which can […]