By Derek Silva, Vice President, Marketing, Intertek
There once was a day when a product might have been deemed “quality checked” if a tiny paper slip fell out of its packaging, saying “Tested by Number 9”. The scrutiny back then, you could argue, was a bit less meticulous than desired. Fast forward to nearly a quarter of the way through the 21st Century. As modern medical technology evolves with leaps and bounds, so does the need for rigorous quality control. Especially when it comes to medical electrical equipment.
Today’s medical device buyers and users, including healthcare professionals and patients, aren’t just concerned with the functionality of a medical device. They are actively invested in understanding its safety measures, as well as chemical composition, sustainability, wireless capabilities, biocompatibility, cybersecurity, and more. There is a much more comprehensive approach to Quality Assurance than ever before. It addresses every facet of your medical device throughout its lifecycle. Savvy medical device manufacturers realize the value of thorough testing before products touch the hands of healthcare professionals or patients.
A modern Quality Assurance program should address the following types of product testing, inspection, and certifications:
Safety Testing and Certification: Ensuring that medical electrical devices are safe for use is paramount. International and regional bodies like IEC, ANSI, and UL set standards for such devices. Countries may also have regulatory bodies to oversee such activities. The most likely place to start is the 60601-1 family of standards but check to ensure which standards are needed for your specific device.
Electromagnetic Compatibility (EMC): It’s crucial that medical electrical devices do not disrupt the functioning of other essential equipment, especially in a clinical setting. EMC testing ensures no unwanted interference occurs. There have been EMC requirements on medical devices for many years and most manufacturers are familiar with the need to comply.
Wireless/Radio Testing and FCC Certification: Many medical devices now incorporate wireless functionality, such as Bluetooth, Wi-Fi, and 4G/5G cellular. Ensuring they meet FCC regulations is vital for safe and effective communications whether inside a professional healthcare environment, a home, or even while out in the community. The advancements of home healthcare equipment are enabling people to be more mobile with their medical devices. The performance must keep up with the patient.
Quality Management Systems and Certifications: In the medical world, ensuring devices meet quality standards is not just about efficacy, but it’s about saving lives. Adhering to QMS certifications like ISO 13485 helps to ensure the device’s reliability overall and reduce the risk of product recalls due to defects or malfunctioning parts.
Battery Testing: Many life-saving devices run on batteries. Their reliability can mean the difference between life and death. Not only should different chemistries be potentially tested for particular uses, but if you’re incorporating lithium-ion batteries in your design they should also be tested to UN DOT 38.3 before they can be transported.
Functional Safety: For medical electrical devices, functional safety is a growing concern. A device needs to perform its primary function without causing harm to patients. As more devices incorporate complex electronics and software in their design, especially those with software-controlled shutdowns in the case of malfunction, design engineers need to address functional safety at the system level.
Cybersecurity Testing: Cybersecurity is no longer a nice-to-have or a should-have in medical devices. It’s now a must-have in many markets around the world. Any medical device that is connected to a network – in fact any device that has inputs and outputs in general – has potential vulnerabilities that could compromise the device’s performance as well as the patient’s health.
Hazardous Chemicals Testing: For years manufacturers have needed to meet requirements for RoHS, REACH, California Prop 65 and other market-specific requirements for hazardous chemicals. Now there are even proposed bans on PFAS (per- and poly-fluoroalkyl substances), aka “forever chemicals”, above certain concentration levels. The European Chemical Agency proposed a ban of the manufacture, import and use of PFAS above certain levels earlier in 2023. The proposal is currently in the public comment stage.
Materials Testing: The materials used in medical devices can directly impact patient health, making rigorous testing critical. Whether testing materials for strength and durability, or for VOC emissions and biocompatibility, every component and material that makes up the device should be considered for safety, performance and overall quality.
Usability Testing: Medical devices should be user-friendly, ensuring healthcare professionals can utilize them effectively to aid in patient care. And, again, with the proliferation of home healthcare equipment, often the users of the devices are not trained professionals. The use and care of the medical devices should be factored into the initial design.
The above topics provide a glimpse into the vast world of medical electrical device Quality Assurance. It’s important to note that Quality Assurance for medical electrical devices isn’t just about ticking off a checklist. It’s about ensuring the ongoing safety, effectiveness, and reliability of devices that healthcare professionals and patients depend on every day.
Assessing potential risks in a medical device and then determining how to eliminate or mitigate them is paramount in developing a robust Quality Assurance program. Working with a partner such as Intertek, whose “Total Quality Assurance” solutions are designed to help manufacturers identify and remove risk from the entire product lifecycle, can save time, cost, and frustration in the product development process. Learn more at www.Intertek.com/medical or contact them today to start minimizing risk and maximizing product quality.
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