By Maurizio Lauria, Brand Manager, STEUTE Meditech Inc.
New European guidelines and standards have greatly increased the testing and documentation required in order to introduce a new medical device, making the process even more complex and time-consuming for medical device manufacturers. Additionally, these standards apply not only to the device itself but the user interface, such as any wireless foot and hand controls, as well. Five areas impacting device manufacturers are highlighted below.
The testing of wireless interfaces and its corresponding documentation had increased considerably over the past few years because of new and/or updated directives. One example is the EU’s “Radio Equipment Directive” (RED) that replaced Europe’s R&TTE directive (Radio and Telecommunications Terminal Equipment) in 2016. Along with these broader standards, medical device manufacturers must also make sure to comply with any country-specific regulations for wireless interfaces used in medical applications.
The increasing number of wireless systems being used in medical environments such as operating rooms and outpatient clinics necessitates a more robust wireless interface to avoid lost signals, cross-talk and inadvertent actuations of the host medical system. To ensure the safety and robustness of the wireless interface, coexistence testing must be performed in compliance with the IEEE / ANSI C63.27 standard. Testing the coexistence with various radio networks or frequencies (WLAN, Bluetooth, Zigbee, microwaves, etc.) is required. Medical device manufacturers must document these results and provide them to the FDA to support the coexistence evidence of the wireless system.
“Off-the-shelf” Solutions & Customized Wireless Interfaces
Some products available for sale off-the-shelf already have wireless radio modules approved for use in North America (FCC), Canada (IC) and Japan (ARIB). These approved modules make it much easier and faster (hence lowering the overall cost) to go to market as the required technical documents are available for use by the medical device manufacturer when submitting the system to their notified body and to the FDA.
Custom-designed wireless interfaces require individual and specific technical documents. These can be created by the medical device manufacturer or by companies who specialize in such interfaces. Ultimately, it is the responsibility of the device manufacturer, as the distributor of the medical device, to provide this documentation and evidence of compliance to its notified body.
Extensive testing and documentation obligations also apply to the individual software written for the customer-specific user interface. This includes the different phases of the life cycle process according to EN 62304, which verifies all functions of the software specification. A test specification is created before the software code is written and the expected results are stated. After programming, the expected result is compared with the actual result to ensure the software performs adequately for the interface.
An important test criterion for the software is the question of whether errors that occur during runtime due to internal or external influences, such as electromagnetic interference, can be recognized and corrected using suitable measures. In the most extreme case, the system must go into its “safe state” in order not to represent any danger itself. The software can only be released if all tests have been passed. Overall, due to the numerous tests that must be documented, such software testing can amount to a few hundred pages and just testing the software requires a few weeks of man-hours. Incidentally, this also applies to wired/cabled human-machine interfaces provided they use individual software.
Risk calculation and analysis
Device manufacturers are also responsible for determining the risks for the patient and the surrounding environment. The requirements of EN 14971 apply to risk management (required and must be documented). A risk calculation must be carried out for each operating system, including cabled interfaces.
These are just a few examples of the requirements to which device manufacturers must comply before bringing a system with a wireless interface to market. In most cases, the testing and documentation obligations are numerous, time consuming and very costly to the device manufacturer. This often prevents smaller manufacturers from using wireless interfaces at all.
As a company with extensive experience working with medical device manufacturers, Steute offers documentation packages for its wireless interfaces to take on some of the burden of these testing and reporting requirements. The company offers off-the-shelf as well as custom solutions, and provides documentation to show compliance with requirements of the FCC (USA), RED (Europe), IC (Canada), and MIC (Japan). The device manufacturer then needs only to check the results of the tests to verify the values after the user foot switch is integrated into the overall system. This gap analysis is much easier to carry out and therefore saves the manufacturer both time and money.
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