Designing, manufacturing, and seeking registration for medical devices requires strict compliance with the set regulations. The International Organization for Standardization (ISO) standard 10993, for instance, outlines the requirements for biocompatibility for medical devices.
National and regional regulatory authorities check biocompatibility tests during product registration to guarantee compliance with set requirements. In this article, we discuss biocompatibility tests and how they help ensure the safety of medical devices.
Role of biocompatibility testing
Medical device biocompatibility testing helps ensure that safety and quality attributes have been incorporated into the design and development of devices. Other than determining the risks associated with the use of medical devices, they help identify any adverse reactions that might occur due to interactions with biological tissues.
Biocompatibility tests
Biocompatibility testing is a complex process and there are many different tests and methods that can be utilized. Essentially, biocompatibility tests are performed to satisfy the requirements for each biological endpoint. The method of test can then vary based on the intent of the test and the regulatory authority to which it is being presented.
Here are some biological endpoints that a biocompatibility test may evaluate:
Cytotoxicity
One of the most basic tests that is used as a general overall screen for potential toxicity is cytotoxicity tests. Through extract dilution and direct or indirect contact, these tests determine whether your device will have a cytotoxic potential.
Sensitization
Delayed hypersensitivity reactions are plausible when medical devices encounter the body. To establish if a medical device or its material will lead to a sensitization reaction, the most widely accepted test is the Guinea pig maximization test.
Irritation
Exposure to an irritant can lead to inflammation of the contact area, which can be an adverse event. To avoid such reactions and guarantee patient safety, before the manufacture of a medical device, irritation tests can be performed.
Systemic toxicity
When a foreign body or chemical gains access to systemic circulation, there becomes a risk of a systemic toxic reaction. A systemic toxicity test helps determine if your medical device presents a risk of systemic toxicity or a systemic reaction.
Genotoxicity
Human genetic material can be altered or damaged by foreign material. To ensure the manufactured device doesn’t interact with the patient’s genetic material, genotoxicity tests can be utilized during the product development phase.
Implantation
When an implantable device is introduced into the body, it can interact with the local tissues around the implant. The response of your body to the implanted device can be noxious, leading to adverse events. To avoid such events, implantation testing can be performed during the development of a device.
Conclusion
If you’re a medical device manufacturer, medical device biocompatibility testing will help increase confidence in the quality and safety of your product. If you don’t know where to start with the testing process, JL Tox Consulting is your reliable partner.