In order to maintain safety and prevent liability, medical equipment needs to be tested in a variety of ways. Here are some of the most essential tests that are performed on medical devices.
Making Sure It's Biocompatible
Biocompatibility is one of the most sensitive issues to test. Researchers may have high hopes for a design material or a new laboratory procedure, but it's impossible to predict how the product will react with living tissue. Biocompatibility tests should be done throughout research and development to make sure that a project is on the right track and safe to continue.
Reducing Side Effects
Aside from long-term studies to test a product's side effect levels, medical device testing companies, like Nelson Laboratories, can offer tests to determine whether a product is irritating to its users or whether certain groups are more sensitive to the medicine than others. These results can help the company design diagnostic tests to determine which patients should or shouldn't use the product.
Meeting Standards for Toxicity Levels
Small levels of toxic materials may be inevitable in some manufacturing processes, but it's crucial to make sure that the toxicity levels don't reach the threshold where the product as actually causing harmful effects. Many medical device testing labs have a toxicology unit where the product can be continually tested for toxicity levels throughout its half life.
Product and Package Sanitation
Besides testing the efficacy of the actual manufactured product, it's a good idea to test the packaging process as well. Especially when a medicine will be delivered to vulnerable populations, the company needs to test the product for a good packaging seal, contamination within the package, and microbe levels on the outsides of the package.
Within the product itself, sterility is often an issue; the packaging can help to keep contaminants out of the product during shipping. Spot checking some batches for post-market sterility is an option, but it may also be wise to have each product tested for sterility before shipping.
Testing Throughout the Design Process
It's important to note that these tests should be performed throughout the design process; medical device tests can be done when a product is first being developed, before it goes to market, and periodically after it goes to market. By using the tests above to do a thorough product analysis, manufacturers can cut back on the number of casualties by the patients who use their products.Share