The continuous advancement of medical device technology has led to a dramatic increase in the number of implantable devices that utilize onboard electronics. For example, devices used to treat cardiac arrhythmia — including pacemakers and implantable cardioverter defibrillators (ICDs) — frequently contain sensors to monitor heartbeats, onboard memory to record that data, processors to determine which therapy is required, and circuitry to generate either electrical impulses or shocks to correct the heart’s operation.
In the U.S. alone, more than 300,000 cardiac arrhythmia devices — which include pacemakers and ICDs — are implanted each year. Neurostimulator implants – such as spinal cord stimulators, which are used to treat chronic pain – are also increasing as new products reach the market. The number of implanted medical devices containing onboard electronics will continue to rise as life-sustaining and life-improving technologies advance.
At the same time, the usage of external electrical devices has become ubiquitous. Each of these devices is capable of generating electromagnetic radiation (EMR) that can interrupt or damage implanted electronic devices. While the European Union (EU), U.S. Federal Communications Commission (FCC), and other organizations have regulations in place to help minimize the amount of electromagnetic interference (EMI) created, some amounts are unavoidable, and even larger amounts can be generated in rare circumstances, or in the event of device malfunction. Thus, preventative measures, including EMI shielding and filtering, must be employed to protect both implantable medical devices and their host patients from harm.