Wireless technology increases the effectiveness of countless every day functions. While some simply are about the convenience factor, like being able to quickly transmit patient records from one hospital to another via email, others have the power to be lifesaving. Medical device manufacturers know that there is significant opportunity to incorporate wireless technology into medical devices. However, design engineers who are extremely knowledgeable about the design of medical devices face a number of challenges in marrying off-the-shelf wireless chipsets with proprietary medical devices in development.
One of the greatest challenges design engineers face is ensuring their devices meet three different sets of standards. The Federal Communications Commission (FCC) has a list of regulations for manufacturers wishing to sell telecom, licensed radio frequency, and low power transmitters in the United States. However, many medical design engineers do not have a background in radio frequency. This increases the potential for risk because a transmitter could interfere with the functioning of the device if placed incorrectly. (See Figure 1)
Along with FCC regulations, each wireless carrier has its own unique set of requirements. Whether using Verizon, Sprint, AT&T, or others, design engineers need to determine which carrier they are going to use prior to chip set placement. This helps engineers design the products to the correct specifications so they meet the requirements of the specific carrier.
In addition to these wireless requirements, medical design engineers must comply with medical industry specifications, such as IEC 60601-1, IEC 60601-1-2, MDD, IVDD, and the CB Scheme.
The IEC 60601 Third Edition standard focuses on risk assessment and essential performance. While designers are already familiar with the standard’s specifications, the standard does not clearly address devices that integrate wireless technology. Such gaps in the existing medical specifications can pose both safety and performance risks, including the possible interference of devices using the same frequency band.
Without a uniform, governing set of standards tying all of the different requirements together, designers are left wondering what tests they should be preparing for and testing to. The FDA knows that this disconnect exists and recommends that manufacturers perform a risk analysis and have their devices verified prior to their submission for approval. This analysis would confirm the overall functionality of the device, ensuring all components operate safely and successfully in their intended environment.
The best time to conduct a design review and determine if any vulnerabilities exist is at the prototype stage. However, most medical design engineers do not have the ability to perform these tests on their own and require the assistance of third party testing and certification laboratories. These service providers can provide medical design engineers with the guidance needed to avoid costly mistakes, meet all necessary requirements, and safely integrate these emerging technologies into their latest product innovations.
This article was written by Nicholas Abbondante, Transmitter Staff Engineer, Intertek, Boxborough, MA. For more information, Click Here