EO testing is used in a wide range of industries. From mining to the construction industry, EO testing helps companies ensure their equipment and systems are performing to their full potential. In this article, we explore the types of EO testing, as well as the requirements for performing it.
Exhaustive extraction
NMTC’s Evo(r) sEEG Electrode received a nod from the FDA, but not without a fight. The company’s NMTC subsidiary submitted a special 510(k) to the FDA, and while the agency was generous in its treatment of the sEEG electrode, it did not swoon over the NMTC’s shiny new product. In a recent blog post, NeuroOne CEO John Aguirre announced the company’s intentions and stated that the Evo(r) sEEG is indeed a worthy contender in the competitive market for surgical electrodes and that NMTC will take the bait and put their best and brightest on the line to ensure a successful outcome for all concerned.
A thorough examination of the product by the FDA’s inspectors revealed some snags. While the Evo(r) sEEG was found to be indistinguishable from the placebo, the FDA ruled that NMTC’s device was unsuitable for
extended use. The agency ruled that NeuroOne’s EEG electrode was not substantially equivalent to a control shunt, and that NeuroOne should come up with a less intrusive way to deliver the aforementioned shunt to the patient’s brain.
Simulated-use extraction
Performing ethylene oxide testing requires the use of various methods to determine the amount of EO and ECH present in devices. The main purpose is to identify the presence of the substance and demonstrate the safety of the sterilized device.
The best way to perform a study is to determine the appropriate testing methods for a specific application. For example, if you are testing a small device, you may want to consider simulated-use extraction as it will simulate the exposure of a small, surface-contacting device to EO.
There are two types of product extraction methods used for evaluating EO residuals: exhaustive extraction and simulated-use extraction. Exhaustive extraction is when the residue of the EO is accessed by the user. The amount extracted must be less than 10% of the residue detected, and this is done in several different methods.
Simulated-use extraction is a reference method to evaluate the amount of EO and ECH available for the user. This method involves the extraction of a small percentage of the EO sterilized device using water.
Direct-drive gimbals vs indirect-driven gimbals
During your selection journey, it’s important to be familiar with the differences between direct-drive gimbals and indirect-driven gimbals. Both have their advantages, and a good understanding of the technologies can help you make a better decision. Here’s a summary of the key differences.
Direct-drive gimbals use motors attached directly to the rotation axes, while indirect-driven gimbals use gears and pulleys. Gear-driven designs can make incremental motion steps in microradians. They also have lower acceleration and rotational speed, and lower duty-cycle capabilities. These are great for medium-performance applications, but they require maintenance and rebuild cycles.
Direct-drive gimbals also have the advantage of higher precision. They can achieve bidirectional repeatability on tens of microradians. The resolution of a high-resolution encoder can allow sub-microradian motion.
The latest generation of high-performance miniature gimbals has built-in software stabilization. This function improves the stability of the video from the moving platform. It’s also an important feature for long-range surveillance applications. It is available only with the latest generation of high-performance miniature gimbals.
Shipping requirements for EO testing
Several factors can affect the results of an EO residuals test. For example, the type of device and its intended use affect the methods of product extraction. If the test is delayed, then it should be frozen with dry ice. This helps prevent the aeration of ethylene oxide during shipping.
There are two common methods of product extraction used for residual EO analysis. One is exhaustive extraction, which involves filling the device with water, and another is simulated-use extraction. These two methods depend on the intended use of the device and the sponsor’s instructions. In both methods, the device is weighed before it is filled with purified water. This allows for adequate detection sensitivity. The device is cooled after filling to minimize loss.
Several factors that can affect the results of an EO residuals analysis include the size of the device, the pre-use instructions of the product, and the type of device being tested. EO residuals can also be affected by grouping and aeration methods.
