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Bioburden and Sterility Testing for Medical Devices

The term bioburden testing refers to the measure of microbial contamination levels present on or inside products such as medical devices. Medical equipment and products are highly sensitive in terms of the areas of their utilization because there is always a possibility of bacteria or other harmful microorganisms to transfer from one living being to another. It is vitally important to test and check the sterility of medical devices before they are brought to practical use. To ensure the safety measures, the FDA and other regulatory authorities require a validated process of testing medical devices once they are manufactured. There are two validated testing processes which are bioburden testing and sterility testing. Let’s look into each of these quality control processes for a better understanding.

Bioburden Testing

A bioburden test is carried out to check the level of microbes present on a medical device or product. The procedure of the test is designed based on appropriate parameters for the type of medical device to be tested. The level and types of microorganisms expected to be present inside or on the device is also taken into consideration. Bioburden testing does not give fixed results and the level of its efficiency can be high or low based on the parameters of the device to be tested. It is important to mention here that before performing the test on the given product, a bioburden suitability test is carried out to make sure that the bioburden test is effective in recovering microorganisms present on that particular product.

Suitability Test

To perform the suitability test, a sterile device is used as a medium and a known number of microorganisms are placed on it. These microorganisms are then removed applying the same technique that is used in bioburden testing. The suitability test shows if the method helped to remove a significant number of microorganisms from the sterile device. Failing to remove a significant proportion gives an idea that the dose for sterilization may be inappropriate. A recovery factor, based on the outcome of the suitability test, is determined and recorded.

Sterility Testing

Sterility testing is performed to check if the medical devices or products are free from the presence of any viable microorganisms. It is highly important in the field of medicine and manufacturing processes of medical products. Typically, sterility testing is done using media called Soybean-Casein Digest Medium (SCDM) and the medical device is placed in it. The required sample can vary based on the testing parameters and the chosen method. Regardless of the method applied in testing, an incubation period of fourteen days is required before a clear outcome. It is important to note that if the media shows signs of turbidity during incubation time, the sample used for testing fails the sterility test. Just like bioburden testing, sterility test also requires a suitability test.

Suitability Test

The suitability test used for sterility testing is known as bacteriostasis and fungistasis. This test shows if the device to be tested for sterility limits the growth of bacteria or fungi, resulting in false negatives that can occur during the sterility test. In the suitability test, the device is placed in the media and then vaccinating the media with fewer proportions of three different microorganisms. If the added microorganisms turn the media turbid, the device is passed for sterility testing.

If you run a lab where medical devices or products are frequently used, you can reach out to professional testing quality testing laboratories in your area to get your medical devices tested 

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