Company insight Biocompatibility: A
development process for medical devices, design inputs address a variety of user needs. Biocompatibility of the final product is a critical design input. Creating a detailed set of design inputs for biocompatibility enables the development team to select the proper components and materials for the device. By planning specifically for biocompatibility – rather than simply planning biocompatibility testing on the end product – the development team may avoid delays and problems during development.
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Biocompatibility planning and strategy
Specifying design requirements for biocompatibility with specific design inputs may streamline the process and prevent failures in testing. Such inputs may include: ■
hen engaging in the
When all components and materials for the device are defined, the indications for use are finalised, and the nature and duration of contact for the device are fully understood, the types of tests required may be defined. The test strategy and justification are best documented in a Biological Evaluation Plan or Biocompatibility Evaluation Plan. This plan may include, but is not limited to: ■
Assessment of biological risks associated with the use of the device or system based on the nature and duration of contact;
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A review of the materials used in the device;
Assessment of any previous data relevant to the device or system (which may include data for components or similar devices), and;
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A risk-based approach to define the biocompatibility evaluation requirements of the finished device will help guide the development process;
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Specifying the intended nature and duration of contact with the patient or user for biocompatibility assessment;
Use of fit-for-purpose components constructed from materials intended for use in medical devices;
Selection of components with certification to USP or ISO 10993 standards for biocompatibility
Use of components that minimise the use of process aids, adhesives or other materials that add to the complexity of the device or system, and;
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Use of materials and components with an established history of use with similar nature and duration of contact.
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The appropriate biocompatibility testing based on the information above.
While it may be tempting to leverage biocompatibility testing of individual components, this approach is rarely, if ever, accepted by regulators. The biocompatibility profile of a device may change as proportions of various materials change; if different process aids (e.g. mold release agents) are used during manufacture; cleaning or sterilisation processes may result in material changes or residual compounds; or where generic material descriptions do not adequately define specific materials. There are few circumstances where a justification to not perform biocompatibility testing on a new device or system is acceptable. However, selecting components with known, acceptable biocompatibility profiles reduces the risk of failing biocompatibility testing of your product.
strategy for medical devices
Addressing biocompatibility requirements for medical devices requires evaluation of various factors. Biocompatibility is a lifecycle approach and must take into consideration the use of the product, the cumulation of materials comprising the device, any residues on these materials from the manufacturing process, biocompatibility test results, and adequate change control to ensure changes that may impact the biocompatibility profile are assessed. Partnering with Qosina will guarantee these are all taken into consideration.
Biocompatibility testing
The specific panel of biocompatibility testing for any medical device or bioprocessing system is dependent on the
recommendations in the Biocompatibility Evaluation Plan and primarily driven by the nature and duration of contact with the patient. When developing the aforementioned plan, ISO 10993-1 and the related FDA Guidance are critical resources for medical devices and provide guidance on which biocompatibility tests should be performed for the finished product. There are numerous firms that provide biocompatibility test services. Many of these same organisations also provide consulting on biocompatibility to inform the specific tests that are appropriate for a particular product, including the generation of a complete Biocompatibility Evaluation Plan. Biocompatibility testing involves the testing of a finished product or a representative sample. For some test methods, the results of the testing directly provide information regarding the biocompatibility of the material. For example, the results of cytotoxicity testing according to ISO 10995-5 are graded on a five-point scale (0–4) with 0 representing no cytotoxic effects and 4 representing severe evidence of cytotoxicity. Other test methods involve the analysis of chemical components that leach from the device materials during normal use or chemical components that are extracted from device materials under exaggerated conditions. Extractable and leachable testing allows the manufacturer of the medical device to fully characterise the chemical makeup of the product and potential impact on the patient. Following the identification of these chemical components, a risk
Medical Device Developments /
www.nsmedicaldevices.com
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