Standards Spotlight

A new type of pacemaker developed by researchers at Northwestern University combines two innovative features to create a remarkable, first-of-its-kind device: a fully implantable, wireless pacemaker that is connected to a “body-area network” of sensors that communicate to monitor physiological functions and provide pacing as needed, and dissolves harmlessly in the body after use.

The pacemaker is ideal for patients who only require temporary pacing after cardiac surgery, or for those who are waiting for a permanent pacemaker. After it’s no longer needed, the transient implant dissolves while releasing an anti-inflammatory drug to prevent adverse reactions. The pacemaker is coordinated with a network of four skin-interfaced devices that provide information on the body’s physiological functions and react to changing conditions to stimulate the heart in real time as needed. This data is also streamed to a smartphone or tablet so that doctors can monitor patients remotely. The system includes a small, wearable haptic-feedback device that vibrates in specific patterns to alert the wearer of an issue like low batteries or incorrect device placement.

Standards support all kinds of medical devices and the technologies that enable these life-saving innovations. Pacemakers are guided by standards like ISO 14705-2, Implants for Surgery – Active Implantable Medical Devices – Part 2: Cardiac Pacemakers, an international document that specifies type tests to be carried out on samples of pacemakers to show compliance. This standard was developed by the International Organization for Standardization (ISO) Technical Committee (TC) 150, Implants for surgery, Subcommittee 6, Active implants. The American National Standards Institute (ANSI)-accredited U.S. Technical Advisory Group (TAG) administrator to TC 150 is ASTM International. ANSI holds the secretariat to SC 6, delegated to the Association for the Advancement of Medical Instrumentation (AAMI), and AAMI is the ANSI-accredited TAG administrator.

AAMI has developed a number of medical device standards specific to pacemakers, such as ANSI/AAMI PC76:2021, Active Implantable Medical Devices – Requirements and Test Protocols for Safety of Patients with Pacemakers and ICDs Exposed to Magnetic Resonance Imaging. This American National Standard (ANS) assures patient safety when implantable pacemakers are exposed to MRIs.

The new pacemaker developed at Northwestern University uses a wireless network of sensors worn on the body that its developers compare to the biological feedback loops that control behaviors in living organisms. Wearable electronics are supported by standards such as IEC 63203-101-1, Wearable Electronic Devices and Technologies – Part 101-1: Terminology. This international document provides standardized terms frequently used in literature related to wearable electronic devices and technologies. It was developed by the International Electrotechnical Commission (IEC) TC 124, Wearable electronic devices and technologies; the Consumer Technology Association (CTA) is the U.S. National Committee (USNC)-accredited TAG administrator of this TC.

Another standard, developed by ASTM International, supports the safety of connected products. ASTM F3463-21, Standard Guide for Ensuring the Safety of Connected Consumer Products, guides these products in relation to safety hazards created by virtue of their connectivity – for example, cybersecurity vulnerabilities that could compromise the safety-related performance of the product.

Data sent from these devices to doctors helps providers to offer remote care. IEEE 11073-10103, Health Informatics – Point-of-care Medical Device Communication Part 10103: Nomenclature – Implantable Device, Cardiac, defines terms necessary to convey a clinically relevant summary of the data obtained from an implantable cardiac device, allowing doctors receiving information from these pacemakers to get a clear understanding of their patients’ statuses. This ANS was developed by IEEE.

Learn more about the incredible new pacemaker developed at Northwestern University: Smart, dissolving pacemaker communicates with body-area sensor and control network