The Food and Drug Administration takes great care to ensure medical devices allowed onto the market will not harm patients they are meant to help. Toward this end, the FDA relies on groups like the United States Pharmacopeia to set standards that reflect the latest safety-related findings and best practices.
Some of these rules encompass a number of specific tests and requirements, each meant to highlight a certain set of important issues. The USP Class VI biocompatibility standard, for example, covers a range of tests that must be passed before a medical device or material can be certified.
Obtaining USP Class VI Certification is an Important Step for Many Products
There are many functional tests applied to medical devices before they can be sold and used. Standards and tests of a more basic kind, though, end up being just as important in practice.
The USP Class VI standard is designed to ensure certified products and materials are as compatible with the full range of biological functions as possible. Establishing this fundamentally significant trait early on makes it easier to ensure a medical device will not come up short in the final analysis.
As a result, most medical devices incorporate materials certified as compliant with USP Class VI wherever makes the most sense. Coatings commonly applied to materials like steel and titanium when they are used in medical devices, for instance, will almost always need to exhibit USP Class VI compliance.
Tests That Highlight Biological Incompatibilities
Naturally enough, USP Class VI comprehends a suitably wide array of tests to set such a high bar. Tests described under the standard use animal subjects to ascertain whether particular materials could be acutely toxic when ingested, inhaled, or injected.
Higher-level tests included in the standard help determine whether particular materials will be biologically incompatible when actually used for specific applications. Coatings that carry USP Class VI endorsements will normally have been applied to dummy devices that were then implanted in animals.
While it takes a fair amount of time and effort to conduct a full battery of USP Class VI tests, the benefits are significant. Standards like this help ensure that materials and devices used in medically significant ways will not do more harm than good.