Medical Device Manufacture encompasses a wide range of health care products that are used to diagnose, monitor or treat a disease or condition that affects humans. Medical technology extends and improves life. It can help alleviate pain, injury and handicap. The endless improvement of medical technology enhances the quality and effectiveness of care and is essential in the healthcare industry.
What are the advantages of using polyurethanes in this industry?
The high strength and ease of processing of polyurethane elastomers makes them the material of choice for soft durometer applications, such as, instrument grips, gaskets, seals, implants, etc. Silicone, for example, another common polymer used in low durometer applications, is difficult to extrude and does not bond easily to other device components made of non-silicone materials. Polyurethanes eliminate the problems associated with other materials such as PVC, where the dangers of leachable plasticizers become a concern. Liquid rubbers also retain their elastomeric characteristics even at low temperatures where PVC becomes brittle.
Rigid polyurethanes also have applications in injection molded devices as component parts or for potting and encapsulating electronics. They are also commonly used for short term implants.
What organization regulates medical device applications?
The United States Food and Drug Administration’s Center for Devices and Radiological Health or “FDA” regulates medical devices.
Are there any polyurethanes that are approved for medical device applications?
Raw materials and component parts are not individually approved by the FDA. The FDA will evaluate the safety and effectiveness of a device for its intended use, and approvals are granted to the final product based on these considerations. In reality, the majority of medical devices entering the market haven’t been FDA approved. In this case, the device manufacturer must file a PMA (Pre Market Approval) on the new device.
Who is ultimately responsible for ensuring Medical Device compliance?
It is always the responsibility of the manufacturer to determine the suitability of all the component parts and raw materials that are used in the finished product.
What influence does raw material supplier test data have on FDA acceptance?
If a polyurethane supplier already has relevant toxicology data about its formulation, it can make that data available for review by the device manufacturer. The importance or desirability of certain toxicological characteristics will vary based on the intended use of the device. For example, the use of a material to make an implant requires more toxicology data than if the same material was used for a device that doesn’t contact living tissue.