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How To Meet Biocompatibility Needs Of Polymeric Medical Components

Vinny Sastri, Ph.D.
Winovia LLC, U.S.A


Medical device manufacturers need to ensure that their products are safe and effective. Safety considerations should include usability, energy, operation, informational, and chemical and biological hazards. Biological hazards can be extensive and complex. When materials come in contact with human skin or tissue, their biocompatibility should be evaluated. The importance of patient safety with respect to biocompatibility continues to be an important area that regulatory bodies continue to focus on.

The international standard ISO 10993-1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, updated in 2009, added the risk management process based on ISO 14971 in the selection and evaluation of biocompatible materials. In 2016, the United States FDA published its final guidance titled Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

.This guidance document covers the use of the standard including specific requirements that the agency expects in selection, testing, evaluation and documentation. In June 2016, the European Parliament and the Council of the European Union published its draft proposal on its new Medical Device Regulation. Section 7 of Annex 1 details the requirements for a medical device and material chemical, physical and biological properties.


In September 2016, the Center for Devices and Radiological Health (CDRH) in the USA published the CDRH Regulatory Science Priorities (FY2017). One of the top 10 priorities for 2017 is to “Modernize biocompatibility and biological risk evaluation of device materials”. The report states that “it is critical to perform biocompatibility evaluation to assess the risk of adverse events” “to determine the safety profile of implantable or patientcontacting medical devices” The report emphasizes that “less burden some approaches that are more patient-centric and predictive of realworld device performance are needed to modernize and transform biocompatibility evaluation of medical devices and their materials.”



The medical device manufacturer is ultimately responsible for the safety and effectiveness of the final device. The device, its components and raw materials that come into contact with human tissue must all be evaluated for biocompatibility. As a result, suppliers of parts, components and resin that are used to build the device should also do their part in ensuring that the products or processing conditions do not adversely affect the biocompatibility of those products. Figure 1 illustrates the raw material to finished device value chain with respect to plastic materials and components. There may be instances where the resin manufacturer directly supplies the raw material to the medical device manufacturer who does their own processing and converting.


Vinny Sastri, Ph.D., is the President of WINOVIA® LLC a company that provides customized solutions, strategies and training in the implementation of effective quality management systems. Areas of expertise include FDA and ISO quality management systems for medical devices and pharmaceuticals, product development processes, design controls, manufacturing and process validation, risk management, six sigma and design for six sigma, CAPA and plastics. He is a certified Six Sigma black-belt.

Dr. Sastri is the author of the book Plastics in Medical Devices: Properties, Requirements and Applications the 2nd Edition of which published by Elsevier, London in 2013.

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