Chronic pain can be a debilitating condition that affects millions of people worldwide. Fortunately, advancements in neurostimulation technologies are providing relief to an unprecedented number of patients affected by debilitating neurologic and psychiatric disorders. ANSI/AAMI/ISO 14708-3:2017— Implants for surgery – Active implantable medical devices – Part 3: Implantable neurostimulators is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system.
What Is an Implantable Neurostimulator?
An implantable neurostimulator is a surgically placed device about the size of a stopwatch. Reduced to its simplest form, a neurostimulator consists of a power supply (i.e., a battery), a pair of electrodes in contact with the tissue, extension wires to connect the electrodes to the battery, and a switch that enables the power to be intermittently connected to the electrodes. The implantable pulse generator (IPG) is implanted in the body along with thin, insulated wires called leads. When the system is turned on, the generator delivers mild electrical pulses to the epidural space near the spine through the leads. By disrupting the pain signals traveling between the spinal cord and the brain, neurostimulation provides pain relief.
What Is ANSI/AAMI/ISO 14708-3?
ANSI/AAMI/ISO 14708-3:2017 specifies requirements for active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system in order to provide basic assurance of safety for both patients and users. The tests specified in this American National Standard are type tests carried out on a sample of a device to assess behavioral responses.
ANSI/AAMI/ISO 14708-3:2017 amends and supplements ISO 14708-1:2014.
How Does Neurostimulation Therapy Work?
Neurostimulation therapy, also known as spinal cord stimulation (SCS) therapy, is a well-established pain treatment used by doctors for more than 50 years. It works by intercepting signals sent by pain receptors along the spinal cord to the brain, so the brain does not receive them. As a result, the person does not experience pain in the same way.
What Is the Neurostimulation System?
An implantable neurostimulation system involves a technology that uses electrical stimulation to treat neuropsychiatric disorders by modulating neural activity in the central nervous system. This technology can be invasive or noninvasive and can target specific structures in the brain, spinal cord, cranial nerve, and peripheral nerves. A complete implantable neurostimulation system includes several components:
- Neurostimulator – The device that generates the electrical impulses (placed under the skin in the abdomen or upper buttock)
- Leads – Thin, insulated medical wires that deliver electrical pulses to the epidural space near the spine
- Physician’s programmer – A device that lets doctors adjust the neurostimulation system and its settings
- Patient’s programmer – A handheld device patients can use after leaving the doctor’s office to customize the stimulation (within the settings the doctor has selected)
ANSI/AAMI/ISO 14708-3:2017— Implants for surgery – Active implantable medical devices – Part 3: Implantable neurostimulators is available on the ANSI Webstore.