Reuse Stress Test
In order to prevent infections in healthcare, reusable medical equipment or instruments are chemically disinfected, and the disinfectant used can be expected to kill the microorganisms present on those instruments. Given that a lot of the disinfectants used in healthcare can be reused for up to 30 days or even 60 days, the same solution disinfects the instruments each day for weeks. Disinfectant manufacturers utilize reusable stress tests to assess the ability of their disinfectants to tolerate or sustain forces and parameters at extreme levels. Reusable disinfectants would generally be High Level Disinfectants (HLD) that are intended to be reused and have different application procedures according to the manufacturer’s instructions, which is an important element in designing and customizing the test procedure. The FDA currently approves the period during which high-level disinfectants may be reused according to the HLD type and their specific criteria.
Testing Overview
Here at TECOLAB, we are able to customize a simulated-use testing for your reusable disinfectant according to its application and claims. It is not sufficient to just test the concentration of your actives by leaving the solution alone for a certain period of time, as per claim. The product will face a daily “stressed” challenge from the organic and microbial load. The only way to be assured that your HLD is effective is by daily monitoring the disinfection solution.
In order for us to customize the test to accommodate your sample, there are 3 key aspects to take into consideration before we run the test, as follows:
1. Understand the Normal Application of the Product
The major thing that needs to be focused on is having a comprehensive insight into the product’s application, which includes every detail, such as the number of disinfections per day, the reuse period, or if there are any other devices involved in the process like ultrasonics et cetera. This is crucial for the next step, which is designing and customizing the test method.
2. Design The Test
The test is customized based on the application of the product. The test is designed based on three main parameters, which are:
The product is a “stressed” challenge with microbial and organic load in a setting that simulates the disinfection process in real life.
3. Determine the concentration of the actives and the efficacy from time to time.
The reuse period depends on the stability of the active ingredients and the efficacy of the solution or product as claimed.
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A reuse stress test is required to demonstrate that disinfectants that claim to be effective up to their respective expiration dates are in fact effective. A disinfectant intended for use in the healthcare industry must comply with the regulation, proven to be effective before legal distribution in order to prevent any healthcare-associated infections among patients. Contact us now for more information!