Medical Plastic Data Service Magazine

 
 

A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY

Our 31st Year of Publication
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Cover Story

About Safety of Materials Used in Medical Devices

 

Materials used in todayís medical devices vary as widely as the devices themselves -whether the material is metal, plastic, silicone, an animal-derived product or some combination of these. Because, in the case of implantable or insertable devices, these materials come into contact with tissue or other parts of the body for sometimes extended periods of time, agencies like US FDA carry out a careful evaluation during their premarket review to determine if there is a potential adverse biological response resulting from contact of the deviceís component materials with the body and whether the associated risks are unacceptable.

 

Specifically, they review information about the materials used in the composition of the device and require companies to include a biocompatibility evaluation or risk analysis, as well as clinical studies, when appropriate. These steps help to address any risks that may be posed by, for example, the potential presence of harmful chemicals or materials that might trigger allergic or other adverse reactions in some individuals. While such testing generally has been a reliable predictor of a materialís safety, they also recognize the importance of advancing the science they rely on to evaluate device materials and patient risk factors both before and after
devices enter the market to assure that it optimally reduces risks to patients and maximize benefits.

 

Understanding of medical technologies evolves over time. With increasing knowledge about long-term effects of materials and as materials science advances and new innovations become a reality, itís imperative regulation of devices evolves along with the advances to ensure patients are protected.

 

Medical device manufacturers typically assess the biocompatibility of a material by determining how the human body may respond to the material they plan to use in their device. Manufacturers have to perform an evaluation of their device to determine if there is a potential adverse biological response resulting from contact of the device's materials with the body and whether the associated risks are acceptable. This risk-based approach typically includes an assessment of the device, including the material components, the manufacturing processes, the clinical use of the device including the intended anatomical location, and the frequency and duration of exposure. Information to support the biocompatibility of the device is then provided to the FDA based upon such evaluation. The FDAís biocompatibility guidance provides recommendations on the information that should be provided.

 

( https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottliebmd-and-jeff-shuren-md-director-center-devices-and-3 )

 
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