Bioburden or Microbial testing refers to the contamination caused by microbial levels in a product. It can stem from different sources, such as raw materials or throughout the manufacturing process. Regularly testing medical devices is imperative to determine the level of contamination and to adopt suitable sterilization techniques. At the onset of the process, a suitability test must occur. This step ensures the efficacy of microbial testing to ascertain the growth of microorganisms in different devices. It commences with placing a few microorganisms on a steel device that are later eliminated. Once a prudent method of testing is validated, they consolidate it with bioburden testing.
BIOBURDEN TESTING AND STERILITY TESTING OF MEDICAL DEVICES
Bioburden testing and sterility testing go hand-in-hand. The lab needs to ensure that the device remains sterile rather than harmful chemicals to obliterate microorganisms. Sterility testing also accommodates suitability testing, known as fungistatic and bacteriostasis testing. These tests discern whether a device restrains bacteria or fungi growth, leading to false negatives during sterility testing. During the procedure, the device is added to the media inoculated. They use three different organisms. Only if all three of them turn the media turbid does the device pass the B&F test and move to sterility testing.
WHY TEST MEDICAL DEVICES?
Medical devices are pivotal to humans. They help in examining different diseases and their root causes. An impaired medical device can skew results and cause apprehension. It may also induce unwanted symptoms among people, which is opposed to their purpose of being instrumental. Hence, to evade such fiascos, medical devices undergo rigorous testing.
The process must ensure a safe environment, free of microorganisms. They are wholly sterilized and made safe for public use.
WHAT ARE THE SOURCES OF INFECTION?
The infection can occur from numerous sources. Raw materials, personnel, equipment, manufacturing processes and callousness can lead to the spread of contamination among medical devices. There are a host of steps involved in the manufacturing and distribution period. Contamination is a likelihood despite the best precautions.
Other sources include air, human handling, contact with surfaces and contact with liquids. It is difficult to ascertain the precise cause, but the team must maintain calibrated processing.
BIOBURDEN TESTING IN-DEPTH
A product never fails or passes a bioburden test. The result is to assemble a product that is safe to use. The test helps in identifying the viable number of microorganisms present on a medical device. These viable microorganisms include bacteria and fungi. The test helps in determining any product contamination that may impact the sterilization program. It is a crucial step that also helps in determining the necessary dosage required for effective radiation sterilization.
There are several bioburden testing methods available in the market.
TYPES OF STERILITY TESTING
Sterility testing is very similar to bioburden testing. Their rationale is alike. These tests are exceedingly important because they vouch for the safety of a device. It is a critical step before distributing the devices for final use. The different types of sterility testing approaches are:
1) Direct inoculation: This type of testing occurs when the sample is added directly into the needed media, making sure that the quantity of the sample is 10% lesser than the comprehensive value. Direct inoculation detects both aerobic and anaerobic microorganisms. Post inoculation, both the media are incubated for 14 days to observe and draw conclusions.
2) Membrane filtration: This is a sterile process that includes enclosed units, enabling concurrent filtration of equal volumes of individual samples being filtered through two membrane filters. The samples undergo incubation for 14 days which facilitates in determining the contaminant.
WHAT HAPPENS IF THE DEVICES ARE NON-STERILE?
Such events can be lethal and life-threatening. Their usage can mar human health and have detrimental consequences. There have been reports of humans perishing at the cost of contaminated medical devices.
Aside from using these effective tools, it is essential to treat medical devices with prudent care. The manufacturing environment must be clean and free of microorganisms. While complete eradication is unlikely, environmental monitoring is essential. It helps regulate air quality, water quality and surface cleanliness. There should be timely visits to ensure the material being used is supreme and packaged with maximum security.
Bioburden testing and sterility have paramount benefits in multiple industries. Their use must be streamlined and adequately supervised. Monitoring, training and controlling can help deliver better results. Both the techniques are exceedingly important and help in detecting microorganisms. These processes are also used in the healthcare, pharmaceuticals and cosmetic domain.