One of the most popular categories of medical devices by sales is cardiology equipment. They are only surpassed by in-vitro diagnostic tools. Cardiology devices make up about one in ten medical devices produced. These might be small, implantable devices or huge, external machines, and they are all used to diagnose and treat cardiovascular issues, including heart conditions.
Cardiology equipment serves several purposes. Some keep an eye out for heart arrhythmias and occasionally take measures to stop irregular heartbeats. Others aid in the heart’s pumping process. Individual valves and artificial organs to replace the heart can be produced.
Stents can be implanted to improve blood flow, and other devices can be used to rearrange the heart’s chambers. Certain cardiology devices perform their functions outside of the body, performing emergency defibrillation or taking over the cardiopulmonary functions during surgery. All medical equipment must be produced following strict guidelines. Cardiology devices must adhere to strict standards because of their vital role. Furthermore, if the device is implanted, it must adhere to the strictest standards possible. Applying the appropriate ISO standard can be difficult for the producer.
Importance of Cardiology Devices
Every human life is based on the heart. One of your body’s top concerns is keeping the heart on a regular schedule, and even a few skipped heartbeats might indicate a serious issue.
Heart “arrhythmia” refers to any interruption or modification of the regular electrical impulses that cause your heart to beat. The term “arrhythmia” refers to any irregular heartbeat, whether it be too fast, too slow, or for a completely different reason. Blood flow issues can result from heart arrhythmia, some of which can be serious and even fatal.
Pacemakers and defibrillators (Implantable Cardioverter Defibrillators, or ICDs) are two of the most popular treatments for many people who are at risk of developing arrhythmia or who already have this problem. Both pacemakers and ICDs assist in restoring a regular heartbeat when the body is unable to do so. Yet, they operate in distinct ways, and in some circumstances, one may be more beneficial than the other.
Types of Cardiology Devices
Following are the different types of Cardiology Devices:
- Implantable Cardioverter Defibrillators
Ventricular arrhythmias, which are potentially fatal, rapid, irregular heartbeats, are frequently seen by people with severe cardiac disease, heart failure, and specific inherited arrhythmias. Some individuals may require an ICD, which shocks the heart with electricity to reestablish a normal heart rhythm. Those with ventricular arrhythmias who have not responded to alternative treatments, such as catheter ablation or medication therapy, are frequently advised to get an ICD.
Two different types of pacemakers exist. The conventional type is inserted beneath the skin and uses electronic leads to link to the heart. A smaller pacemaker that doesn’t require transvenous leads is implanted inside the heart. Bradycardia, a disorder where the heart beats too slowly – less than 60 beats per minute – is treated using pacemakers. The pacemaker generates electrical pulses that maintain a regular heartbeat.
- Biventricular Devices
To resynchronize the contractions of the left lower chambers of the heart or ventricles, a biventricular pacemaker functions similarly to a conventional pacemaker but uses a third wire to transmit electrical impulses to the heart. A biventricular pacemaker, also known as a cardiac resynchronization device, is placed when drugs for heart failure, a condition in which the heart does not pump enough blood to the body and when the left chamber does not pulse in unison, do not improve symptoms.
The two ventricles start contracting at different times as a result of this. The contractions of the left ventricle are coordinated by a resynchronization device. For those who would benefit from resynchronization but also need to be protected by a defibrillator, there are also biventricular defibrillators available. This hybrid device helps to keep the heartbeat constant while also speeding up or slowing down an irregular heartbeat. For our professionals to assess your heart health and modify your treatment as necessary, it also captures information about your heart rhythm.
- Implantable Cardiac Loop Recorders
Your cardiac electrophysiologist could advise having a loop recorder, and a wireless cardiac monitor, implanted. For up to three years, this device continuously gathers data about your heart’s rhythm. The implantable cardiac loop recorder, which is less than the size of an AA battery, is put beneath the skin of the upper chest to record data on the electrical activity of the heart, much like an electrocardiogram, or EKG. It is used to determine the cause or make a diagnosis of arrhythmia.
Candidates for this device may include those who have experienced inexplicable fainting spells or heart palpitations that short-term cardiac rhythm recording devices, such as Holter monitors, are unable to detect. In addition, doctors might advise an implantable cardiac loop recorder for patients with atrial fibrillation, a condition that results in an erratic and quick heartbeat. Also, this device is used in patients who have experienced an undiagnosed stroke.
Standards and Regulations for Cardiology Devices
The standards and regulations relevant to cardiology devices are complex due to their critical nature and their frequent and prolonged contact with patients. The following standards are particular to cardiac medical devices in addition to ISO 13485:2016, which applies to all medical devices:
- Active implantable cardiac devices: general safety, labeling, and manufacturer information standards (ISO 14708-1:2014).
- ISO 14708-2:2012 – Pacemakers for the heart.
- Circulatory support devices are covered by ISO 14708-5:2010.
- Specific standards for active implantable medical devices used to treat tachyarrhythmia are outlined in ISO 14708-6:2010.
- Heart rhythm management devices, symbols to be used with labels for cardiac rhythm management devices, information to be provided, and general requirements are covered in ISO 27185:2012.
- IEC 62304:2006 – Software for medical devices
Manufacturers must comprehend and apply this standard properly. the risk of CVDs and other related health issues is now more widely acknowledged, which is a crucial component in the market for cardiology devices. It can be linked to increased public knowledge of healthcare issues due to increased internet visibility, private hospital heart program, and government outreach initiatives from organizations like the CDC. Customers are aware of the signs that a cardiac issue is developing, the value of an early diagnosis, and the range of possible treatments.
To maintain a regular rhythm in your heartbeat, a cardiac device is used. There are numerous available device types. Your doctor will inform you whether you have heart failure with reduced ejection fraction (HF-rEF) and require a device and will discuss the optimal model with you. Any queries or worries you may have regarding this course of therapy should be communicated to your doctor or nurse.