You can risk everything with medical devices that don’t work every time
Dependability is considered the most important aspect of a medical device. While features, cost, and usability are important, a medical device that does not function reliably when needed—or fails during use—can result in injury, severe morbidity, or death. A failure in a medical device isn’t just an inconvenience; it can be a life-threatening event. During surgery a device must function as expected to avoid causing trauma or complications.
Trust is also a vitally important issue; patients and clinicians must trust that the equipment will work when the stakes are at their highest. Further, dependable devices require less maintenance, incur fewer repairs and reduce the need for replacements.
Certain standards must always be met, which is why regulatory bodies such as the FDA (USA) and EMA (EU) define device “quality” through rigorous standards that prioritize safety and reliability. The FDA has stated, “The failure rate of a medical device is equal to the sum of the failure rates of its components. For a product to be reliable, defective, weak or out of specification components must be weeded out. This is done by functional testing and stress testing.”
Blue Goat Cyber, in a Nov. 16, 2024 article, said, “The effectiveness and reliability of medical devices depend on one critical aspect: patient safety.”
Boston Engineering, manufacturers of medical devices like image system controllers, infusion pumps and ventilators, said in an article released on Dec. 16, 2025, “In healthcare, reliability is not optimal, it’s essential. A medical device that fails, even once, can put patients at risk, disrupt clinical workflow and damage brand reputation.”
A medical device that loses its signal is a particularly concerning problem in the O.R. For example, wireless patient monitors, particularly telemetry units, have experienced critical failures in operating rooms (O.R.) and surrounding procedural areas due to signal interference from other high-frequency equipment, such as electrosurgical units (ESUs) or congested Wi-Fi networks. This is a critical issue because loss of signal eliminates real-time, objective data in vital functions, leaving anesthesia and surgical teams blind to immediate life-threatening complications.
And, according to Sunbird Medical Devices, medical device software consultants, “When we are dealing with medical devices, we expect them to be reliable. Reliability is the probability at a desired confidence level that a device will perform a function without failure, under stated conditions, for a stated period of time.”
One medical device component manufacturer that has gone the extra mile in terms of its commitment to product reliability and patient safety is Steute Meditech, recognized as the world’s technological leader in manufacturing both cabled foot switches with superior engineering and wireless foot switches with unmatched signal strength as vital components of medical device systems like the ones you would find in operating rooms.
All of their products are medical-grade which ensures portability, cleanliness, sealing integrity, and compliance with critical medical device directives and standards (like IEC 60601 and relevant subsections). Steute tests exhaustively to meet and exceed IEC 60601 requirements and all of their foot switches undergo a 100% final inspection. And they work with their OEM customers to help them with necessary documentation and certifications to help ease regulatory requirements.
The single most important feature of a medical device? That it works every time!
