Modern medicine has provided millions of heart patients with devices that properly pace the rhythms of their hearts, restore proper blood circulation, and replace diseased valves that would otherwise greatly limit life expectation. Medical devices for the heart also save the lives of heart patients who find themselves on the heart transplant list awaiting donation of healthy hearts. Many heart patients living here benefit every minute of every day from these miracles of medical science that enable their hearts to function as they should. The medical devices that are designed and built for proper heart function must adhere to the strictest of medical device compliance standards set by the government in order to improve the heart muscle and facilitate healthy lives for the patients who use them.
The United States Food and Drug Administration (FDA) is the agency of the U.S. Government that is tasked with approving drugs and medical devices as well as developing standards and regulating their usage. The job of the FDA is to ensure that manufacturers adhere to stringent medical device compliance in order to safeguard their effectiveness and safety in use in all heart patients. A branch of the FDA has been established specifically to oversee that such safety standards are met and upheld at all times. This branch is the Center for Devices and Radiological Health, or CDRH, whose job it is to secure the manufacture and use of every medical device manufactured and sold in the United States, from tongue depressors and sutures to the devices that assist the heart in functioning more effectively. Additionally, the CDRH is responsible for the inspection of every company that is in the process of inventing new innovations in the field of medicine in order to ensure that they are following the strictest of regulations. The FDA’s rigorous requirements and specifications must at all times be upheld by all such companies in order to ensure medical device compliance.
One of the most commonly used medical devices for the heart is the cardiac pacemaker. This is a battery-powered mechanism that is built to be implanted in order to facilitate normal rhythm for patients whose hearts are beating at abnormal pace. The job of a pacemaker is to monitor the pace of the heart, help it to beat at optimal rhythm, and prevent heart attacks. A pacemaker’s tiny wires are implanted into the tissue of an abnormally paced heart in order to send electrical impulses, thereby regulating heartbeat.
VAD, or ‘ventricular assist device, is a mechanical pump that is designed to help a weak heart pump adequate amounts of blood, thereby aiding in proper blood circulation from the heart to the other systems of the body. VADs are also referred to as the bridge to transplant because they are often utilized in patients awaiting heart transplant. Additionally, VADs are gaining more widespread use as longterm therapy for patients whose hearts are severely defective and yet are not considered candidates for the heart transplant list.
Cardiac stents are small metal tubes used to improve blood flow and circulation from the heart and throughout the body. Stents are widely utilized in heart patients and are designed to be inserted into arteries in order to open them up, thereby facilitating better flow of blood. Today, more cardiac stents are being used than ever before that contain drugs in order to reduce future artery blockage.
ICDs, or implantable cardioverter defibrillators, are used to prevent sudden cardiac death. These are small devices that are utilized in heart patients with a history or risk of recurrent, sustained ventricular defibrillation or tachycardia, meaning a quick pace that lasts for a minute or more. Because such a fast rhythm requires medical intervention in order to achieve normal rhythm, ICDs are designed to monitor the rhythms of these patients and restore normal pace when unstable heart rhythms are detected. Some ICDs are designed to record electrical patterns of the heart in order to send such data to a patient’s doctor for better monitoring.
A cardiac ablation catheter is a thin, flexible tube that is threaded onto or into a heart in order to control a heartbeat that is too rapid. Ablation catheters typically are used in patients whose heart rhythms are unable to be corrected or controlled through the use of heart medications and/or by altering their lifestyles. Ablation catheters are built to modify heart tissue that may be causing abnormal heart rhythms.