Bioburden Testing

Keeping Patients and Doctors Safe

What is Bioburden Testing?

• It is microbial testing performed on medical equipment and products.

• It measures the number of living organisms on a surface prior to final sterilization and use.

• Certain microbial levels are allowed during handling of a product, and Bioburden testing makes sure those limits are in force.

• Bioburden testing shows how many living organisms are present and how to best sterilize the product in question.

• It is usually performed before large numbers of a product are manufactured so that the sterilization procedure can be implemented into the assembly process.

• Random testing must be performed regularly to ensure levels have not changed.

How is Bioburden Testing Regulated?

• All Bioburden tests must conform to the procedure outlines in ISO (International Organization for Standardization) 11737.

• Tests must fit the basic FDA criteria which include testing for the following:– Yeast Candida albicans – Bacteria Escherichia coli– Bacteria Pseudomonas

aeruginosa– Bacteria Staphylococcus aureus– Fungus Aspergillus niger

How is Bioburden Testing Performed?

• Swabs of the outside of a product are collected and grown in petri dishes.

• Once the samples have grown, they are tested for various bacteria, fungi, and other contaminants.

• Bioburden is measured in colony forming units (CFU) per gram of product.

• A sterilization procedure is determined.

• For a visual representation of the Bioburden testing process, watch this Youtube video. http://www.youtube.com/watch?v=1rCuoEAMVT8

What Would Happen Without Bioburden Testing?

• Without a proper way to test what still needs to be sterilized on a product, bacteria or strains of diseases could come in contact with someone’s body.

• Imagine an unsterilized metal plate being inserted into a person’s leg. The risk of infection to the patient and the surgeons who inserted it rises exponentially.

Sterilization after Bioburden Testing

• Sterilization can be performed two ways.

• 1. Radiation• 2. Ethylene Oxide

1. Radiation

• Radiation sterilization can utilize different forms of radiation including– X-rays– Electron beams– Gamma rays– Ultraviolet light

• Radiation kills microbes without affecting the integrity of the product.

2. Ethylene Oxide

• Ethylene oxide is a toxic gas used to sterilize temperature-sensitive materials

• It penetrates most plastic, paper, and cloth products to kill microbes.

• It can be used repeatedly on the same product without harm.

Bioburden testing helps keep medical equipment safe for use by finding harmful

microbes to eradicate during the sterilization process.

What do you think about Bioburden testing?