Common Medical Devices for The Heart
Several medical devices are available to keep the heart beating. The FDA, or Food and Drug Administration, is responsible for approving medical devices. Many devices are pitched to the FDA each year with only a few being approved for further testing or use on a regular basis. All of these devices must meet or exceed medical device compliance regulations in the country of use.
Left Ventricular Assist Device
Known as an LVAD, a left ventricular assist device can be inserted into the heart cavity of a patient. The function of this device is to use a tube to pull blood from the heart and send it to a pump. The pump sends blood to the aorta.
This device meets medical device compliance in the UK as well as in the US and Canada. Other parts of the world are also beginning to use this device as it has proven to be successful since its introduction to heart patients in 2005. The device was initially constructed in 1998 but required years of testing and studies before approval for use in patients could be granted. One of the leading manufacturers of this LVAD is HeartWare International.
Pacemaker
A pacemaker is a device that is implanted inside the chest area, or in some cases the upper abdomen. Its purpose is to help the heart to contract to create a heartbeat. The pulsations are delivered by electrodes that are safe for medical implantation instances. Pacemakers are used mainly to treat arrhythmia, or an irregular heartbeat. Arrhythmia can make a heart beat too fast or too slow, requiring regulation from a pacemaker that follows medical device compliance in the US, Canada and the UK along with other parts of the world.
The first pacemaker was constructed in 1899 by J. A. McWilliam. This device was external and was used to regulate a patient in asystole to return a stable heart rate of 60 to 70 beats per minute. In 1926 the device became portable with the credit being given to Dr. Mark C. Lidwell and Edgar H. Booth, a doctor and physicist. The portable version was stronger than the original created by McWilliam and was able to sustain a heart rate of 80 to 120 beats per minute. The first implantable pacemaker was designed in 1958 by Rune Elmqvist and surgeon Åke Senning. An intracardial version was devised and approved for use in 2013 that is the size of a multivitamin and is inserted via incision in the leg.
Implantable Cardioverter Defibrillator
First used in humans in 2003, the implantable cardioverter defibrillator is a small, battery operated electrical pulse generating device. Part of the pharmaceutical compliance for this device to meet medical device compliance in Canada, the US and the UK is that the battery power must not pose a threat for electrocution. The device must have some liquid resistance to prevent an over-shock or malfunction.
With this device, cardiologists are able to program it specifically for a particular patient. It is supposed to detect an irregular heartbeat on its own and correct it by sending several small and brief pulses to the heart.
Stents
Perhaps one of the most common devices for treating heart disease and other heart ailments is stents. Essentially this is a mesh tube that is inserted into natural passages, mostly coronary arteries, in the body. Given that this is mesh, it must be medically safe in order to prevent infection and malfunction. Some stents can be coated in medicine when they are meant to be temporary. Their main function is to increase flow to and from the heart.
Advancements in medical technology have made it possible for devices to be implanted into the heart and chest cavity to regulate heart rates and return quality of life to heart patients. These devices all have strict medical compliance regulations to meet, which vary depending on the device. The main compliance demands that are musts include sterile tubing, liquid/water resistant and surgical-grade tubing, mesh and other components. These devices have been known to save the lives of millions of patients and buy thousands of others enough time to get to a hospital for more advanced care. Some devices do require maintenance such as a battery change or reprogramming but otherwise are care free.
Left Ventricular Assist Device
Known as an LVAD, a left ventricular assist device can be inserted into the heart cavity of a patient. The function of this device is to use a tube to pull blood from the heart and send it to a pump. The pump sends blood to the aorta.
This device meets medical device compliance in the UK as well as in the US and Canada. Other parts of the world are also beginning to use this device as it has proven to be successful since its introduction to heart patients in 2005. The device was initially constructed in 1998 but required years of testing and studies before approval for use in patients could be granted. One of the leading manufacturers of this LVAD is HeartWare International.
Pacemaker
A pacemaker is a device that is implanted inside the chest area, or in some cases the upper abdomen. Its purpose is to help the heart to contract to create a heartbeat. The pulsations are delivered by electrodes that are safe for medical implantation instances. Pacemakers are used mainly to treat arrhythmia, or an irregular heartbeat. Arrhythmia can make a heart beat too fast or too slow, requiring regulation from a pacemaker that follows medical device compliance in the US, Canada and the UK along with other parts of the world.
The first pacemaker was constructed in 1899 by J. A. McWilliam. This device was external and was used to regulate a patient in asystole to return a stable heart rate of 60 to 70 beats per minute. In 1926 the device became portable with the credit being given to Dr. Mark C. Lidwell and Edgar H. Booth, a doctor and physicist. The portable version was stronger than the original created by McWilliam and was able to sustain a heart rate of 80 to 120 beats per minute. The first implantable pacemaker was designed in 1958 by Rune Elmqvist and surgeon Åke Senning. An intracardial version was devised and approved for use in 2013 that is the size of a multivitamin and is inserted via incision in the leg.
Implantable Cardioverter Defibrillator
First used in humans in 2003, the implantable cardioverter defibrillator is a small, battery operated electrical pulse generating device. Part of the pharmaceutical compliance for this device to meet medical device compliance in Canada, the US and the UK is that the battery power must not pose a threat for electrocution. The device must have some liquid resistance to prevent an over-shock or malfunction.
With this device, cardiologists are able to program it specifically for a particular patient. It is supposed to detect an irregular heartbeat on its own and correct it by sending several small and brief pulses to the heart.
Stents
Perhaps one of the most common devices for treating heart disease and other heart ailments is stents. Essentially this is a mesh tube that is inserted into natural passages, mostly coronary arteries, in the body. Given that this is mesh, it must be medically safe in order to prevent infection and malfunction. Some stents can be coated in medicine when they are meant to be temporary. Their main function is to increase flow to and from the heart.
Advancements in medical technology have made it possible for devices to be implanted into the heart and chest cavity to regulate heart rates and return quality of life to heart patients. These devices all have strict medical compliance regulations to meet, which vary depending on the device. The main compliance demands that are musts include sterile tubing, liquid/water resistant and surgical-grade tubing, mesh and other components. These devices have been known to save the lives of millions of patients and buy thousands of others enough time to get to a hospital for more advanced care. Some devices do require maintenance such as a battery change or reprogramming but otherwise are care free.