As technology develops, wireless functionality is being incorporated into medical devices more and more. This adds a new layer to the manufacture of these devices because wireless functionality requires regulatory compliance and SAR testing for medical devices. This of course also requires knowledge of RF regulations in order to be sure that the medical device is safe, fit for its purpose, and compliant.
However, medical device manufacturers commonly focus on the clinical aspects of the products they produce rather than the impact of the use of these wireless devices in close proximity to the user, other electrical equipment or wireless devices. This is why we felt that it may be helpful to discuss RF’s effect on these devices and SAR testing for medical devices.
Radio Frequency in Wireless Medical Devices
Medical devices that utilize radio frequency (RF) are devices that require the use of wireless RF technology like Bluetooth, Wi-Fi, or cellular/mobile to carry out a function that supports the delivery of healthcare. Some examples of this healthcare delivery include:
- Controlling and programming medical devices
- Monitoring patients remotely
- Transferring patient data from a medical device to another platform
Regulations of Medical Devices Using RF Energy
Wireless medical devices can transmit RF energy using either a licensed radio spectrum or an unlicensed spectrum depending on the specified frequency bands. A licensed spectrum allows for both exclusive and non-exclusive use of precise frequencies or channels in certain locations. Unlicensed RF devices operate under the rules of FCC Part 15 and require that no “harmful interference” is caused as well as that interference from primary users of that frequency band is accepted.
Of course, as RF technology continues to improve and change, it will be incorporated into the design of medical devices in even more ways. In addition to this, it’s a challenge for multiple types of wireless technologies to coexist in the same space.
With regard to the regulation of RF used in medical devices, the Federal Communications Commission (FCC) oversees the use of the public RF spectrum that these wireless technologies operate in. Because these are medical devices, the FDA also coordinates policies with the FCC to provide medical device manufacturers with standardized regulatory requirements for medical devices using RF. It’s recommended by the FDA that medical device manufacturers consult the FCC’s website for updates regarding specifications and regulatory requirements. However, that’s a lot easier said than done. This is why it’s important to have a trustworthy testing lab on your side when it comes to SAR testing for medical devices.
Medical Device SAR Testing
Medical devices are regulated more heavily than almost any other product type available on the market, and with good reason. If a medical device fails for any reason, the patient won’t receive a benefit from the device, or it could even cause a fatality. In addition to this, if the product exposes the patient to an unsafe amount of RF energy, this could cause serious health effects as well. Obviously, none of these options is acceptable when it comes to medical care, so it’s understandable that these devices are so heavily regulated.
This is why SAR testing for medical devices is so important for the safe and effective use of these wireless devices. Manufacturers must ensure that these products operate on the correct frequency, transmit the right power level, and don’t expose patients to an unsafe amount of RF energy.
In order to regulate wireless medical devices, the FDA created the Radio Frequency Wireless Technology in Medical Devices document to provide recommendations that will lead to the manufacture of safe and effective wireless devices. Along with consulting the FCC’s website for updates regarding regulatory requirements, the FDA also recommends that medical device manufacturers read this document and review related standards and guidance documents.
How RF Exposure Lab Can Help
As you can see, the FCC’s and FDA’s requirements and regulations of SAR testing for medical devices are complicated and can be difficult to navigate. It can be confusing and time-consuming to figure out which requirements and tests apply to your product. In fact, some wireless medical devices don’t require SAR testing, and it’s beneficial to work with a lab that will let you know when this is the case for your product.
RF Exposure Lab has considerable experience and expertise in RF compliance testing for global markets. Jay Moulton, Chief Engineer, was even involved in creating the testing and methodology that has been used to establish today’s FCC requirements. We also remain up-to-date on the latest regulation changes to ensure we only perform relevant tests.
We are the only standalone SAR testing lab in the United States and apart from offering testing services for client products, we also provide design suggestions for manufacturers to guarantee that they meet all SAR testing requirements before completing the design process.
With help from RF Exposure Lab, you can avoid costly compliance failures and product redesigns, which will allow you to save money and get your product on the market as quickly as possible. For SAR testing provided with speed, expertise, accuracy, and integrity, contact us today.