Medical devices have become essential in the global effort to treat and combat medical conditions. As these devices become more complex and engrained into much of the world’s healthcare systems, microbial contamination prevention across such devices has become a priority for companies within the Biologic industries. Headlines of quickly spreading pathogens affecting various areas of the world, the increase in multi-drug resistant microbes, and tighter restrictions enforced by regulatory agencies have aided in the prioritizing of contamination prevention. The Center for Devices and Radiological Health (CDRH), the FDA branch that regulates medical devices in the US, has categorized over 1700 types of devices into 16 medical specialty panels, such as cardiovascular, dental, general hospital, surgical, etc.
(https://www.fda.gov/medical-devices/classify-your-medical-device/device-classification-panels)
Each device is assigned to either, Class I, Class II or Class III. In terms of safety, the risk factor and regulations increase from Class I to Class III respectively. The device class also determines the type of premarket submission required for FDA clearance to market; generally, Class I and II devices require a 510(k) premarket notification, if not exempt, and Class III devices require a premarket approval (PMA). This makes medical device testing a complex process and choosing the best testing approach to verify the safety of these products regarding the risk of microbial ingress can be a challenge.
A major factor of this challenge comes from variability in the design and application found across the wide range of medical devices. Devices which are manufactured as a sterile final product are often designed to be used a single time and then disposed, some devices are reusable and require a reprocessing cycle between uses, and others are marketed non-sterile if the intended use is associated with a very low risk. Additionally, some devices are manufactured with antimicrobial properties inherent to their composition. Despite great efforts by industry members to maintain the functional and sterile integrity of medical devices, the potential for microbial contamination continues to be a risk as a source of infection to the patient. The non-intended introduction of microbes (such as bacteria, yeast, mold, fungi and viruses) can occur during production, sampling, packaging, storage, or transport of products. Further potential risks at the end-use location include environmental contamination after the package is opened and inadvertent contamination by personnel prior to or during use. For reusable medical devices, deficiencies in the sterilization and reprocessing cycle may introduce contaminating microorganisms. Due to the vast diversity in structure and function of medical devices, there is no single approach to determine the origin of microbial pathogens and how they are transferred (e.g. via particulate matter or a liquid drop) to a potentially vulnerable area on the device.
Additionally, differing products may also require different levels of testing. For example, a medical device marketed to dental professionals who intend to use the same device on multiple patients and a barrier glove used by professionals manipulating products of animal origin both may require a microbial ingress test; however, the same exact study will not fit the needs of both products. Confusion around the level, type, and necessity surrounding medical device testing can make conducting a microbial safety test particularly challenging. As a result, every test against microbial contamination is unique to the individual product being tested and requires a custom approach.
With seemingly endless variability, how do you ensure your medical device testing is compliant? This is where the appropriate laboratory comes into play. Microbial ingress testing may require collaboration between multiple disciplines to produce an effective outcome. Scientific expertise is crucial to understand exactly what elements need to be tested and how that testing needs to be conducted in order to ensure compliance. Engineering expertise is often also required. Many products require custom testing mechanisms and procedures in order to ensure a reliable, time efficient, and cost-effective study. Often many providers require outsourcing of the design and engineering function, which can increase delays and testing time considerably. Minimizing the amount of time needed to develop the testing mechanism and protocol can greatly influence study time. Finally, each study requires extensive cooperation between the product manufacturer and the testing facility. Therefore, finding a team that is experienced, flexible and ultimately easy to work with is extremely important and will minimize unnecessary market entry time.
If you need a test to verify the safety of your device regarding microbial ingress, BioScience Laboratories excels in all areas necessary to meet your needs. We can help you assess microbial ingress during the development process of your medical device or in the sampling process of your final product. We can assist you in designing a study that simulates the intended use of the device, whether it is for a single use or multiple repeated uses. We can evaluate the efficacy of the antimicrobial treatment on your medical device. We have over 27 years of experience providing custom testing and scientific expertise. Our local engineering partners at Autopilot Design also facilitate the design of custom testing devices and procedures in order to provide and easy and time efficient testing process. Our experts are standing by to discuss and help get your study under way. Through our expertise we get you the data you need on the timeline you want.
For information on how to get your microbial ingress test underway, call John Dyba at 406 587 5735 or email us at experts@biosciencelabs.com.
Examples of our capabilities for medical device testing:
Microbial Ingress (needleless connectors, catheters, wound dressings)
Dye Ingress (penetration)
Bubble Leak Tests
Synthetic Blood Penetration (Materials used for protective Clothing)
Viral Penetration (Materials used for protective Clothing)
Barrier Testing
Microorganism Identification
Preservative Effectiveness Testing
Bioburden
Sterility
Stability
Cleaning Validation
Disinfectant Testing: Challenge of Bacteria, Fungi and Virus
Antimicrobial Fabric and Textile Testing