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Bioburden Testing Keeping Patients and Doctors Safe

Bioburden Testing

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Bioburden testing helps keep medical equipment safe for use by finding harmful microbes to eradicate during the sterilization process.

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Page 1: Bioburden Testing

Bioburden Testing

Keeping Patients and Doctors Safe

Page 2: Bioburden Testing

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.

Page 3: Bioburden Testing

• 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.

Page 4: Bioburden Testing

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

Page 5: Bioburden Testing

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.

Page 6: Bioburden Testing

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

Page 7: Bioburden Testing

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.

Page 8: Bioburden Testing

Sterilization after Bioburden Testing

• Sterilization can be performed two ways.

• 1. Radiation• 2. Ethylene Oxide

Page 9: Bioburden Testing

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.

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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.

Page 11: Bioburden Testing

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?