Introduction:
A medical device is a machine or product used to diagnose, treat, cure, or prevent disease. They range from simple to complex, small to large, and are considered the most innovative technology. The ultimate goal of medical devices is to provide better care and outcome for the patient. Examples of medical devices include blood pressure meters, wheelchairs, contact lenses and solutions, blood glucose, pregnancy kit, and complex equipment like hip implants, infusion pumps, artificial heart valves, and coronary pacemakers. Medical devices are manufactured and designed with the intended purpose of enhancing the quality of life and safety.
What Are Medical Devices?
A medical device is any apparatus, instrument, implement, appliance, machine, software material, reagent for in-vitro use, or material intended by the manufacturer for use alone or in combination with others for medical purposes. There are an estimated two million medical devices categorized into more than 7000 generic device groups. The absence of medical devices can hinder medical procedures such as bandaging sprained ankles, diagnosing Acquired human deficiency disease (AIDs), surgical intervention, or implanting an artificial hip.
Medical devices are used by various individuals in diverse settings. For example, medical devices are used by paramedical staff, laymen at home, dentists, opticians, and health care professionals in advanced medical facilities for screening and prevention and in palliative care.
Such health technologies are used to monitor and diagnose illness, assist disabled people, and treat and intervene in acute and chronic diseases.
What Are the Different Types of Medical Devices?
Medical devices are designed to aid in monitoring, diagnosing, or treating medical conditions.
The different types of medical devices are:
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Diagnostic devices include medical imaging machines used in diagnosis. Examples are computed tomography (CT) scans, magnetic resonance imaging (MRI), and ultrasound.
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Treatment devices include medical lasers, infusion pumps, and light amplification by stimulated emission of radiation (LASER).
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Life support devices include a ventilator, infusion pump, and defibrillator.
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Software devices such as computer-aided diagnostics.
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Personal protective equipment such as a gown, mask, and gloves.
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Laboratory and surgical equipment.
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Medical devices such as patient monitors, hemodialysis machines, and anesthesia machines.
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Single-use devices such as catheters and syringes.
What Is Nomenclature for Medical Devices?
The nomenclature for medical devices uses the naming system and coding used to genetically identify and classify medical devices and health-related products. According to different nomenclature and classification systems, there are 5000 to 24000 types of medical devices. They range from inexpensive to costly and simple to complex. Sometimes nomenclature becomes difficult to communicate, which results in economic, social, and health impacts. The important information that negatively impacts the absence of standardized nomenclature includes the intended use of the medical devices, patient safety, regulatory status, adverse event, and technical information.
What Is Medical Device Safety?
The safety of medical devices depends on well-informed action and attention at all levels. It is very necessary to safely handle all medical devices for self-assurance and protection.
How to Use Medical Devices Safely?
The use of the medical device can be done by
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Knowledge of how the device works and reading all the instructions.
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Understanding and responding to medical device alerts and alarms.
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Having medical supplies in case of emergency and backup plans.
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Educate caregivers and family about the device.
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Medical devices should be used only after physician recommendations.
What Is Classification of Medical Devices?
The classification of medical devices is based on the risk to patients, people, and users associated with them. The list of criteria of the medical devices is based on the following:
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The risk to the user, patient, and other people.
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Degree of invasiveness in the human body.
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Duration of time.
What Are High-Risk Medical Devices?
High-risk medical devices include pacemakers, artificial heart valves, coronary stents, and implantable cardioverter defibrillators (ICDs). The high-risk medical devices are those that are:
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Used in the treatment of a patient where device failure can compromise the treatment.
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Used in screening vital parameters of the patient and containing data that are necessary for treatment.
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They are necessary to sustain or support life during patient care or treatment.
What Are Forms of Radiation Produced by Medical Devices?
Devices should be manufactured, designed, and packed so that exposure to radiation should be reduced. The different types of radiation are:
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Intended Radiation: The devices which are designed to emit hazardous or potentially hazardous levels of visible or invisible radiation necessary for some specific medical procedure. Such devices should be manufactured and designed to ensure the productivity of product design.
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Unintended Radiation: Devices should be manufactured and designed in a way that exposure of users, patients, and other individuals to the emission of stray, scattered, and emission of unintended radiation is further reduced.
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Ionizing Radiation: Devices intended to emit radiation should be designed and manufactured in a way to ensure the quality, quantity, or energy distribution of radiation emitted.
What Are the Benefits of Medical Safety Devices?
The benefits of medical safety devices are :
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Improved diagnosis and treatment.
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Ability to monitor chronic disease.
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Enhanced patient and clinical experience.
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Better medical device management.
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Ability to have an idea of diseases in future generations through data collection.
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Cost and time-saving for the patient's diagnosis and treatment.
What Is a Medical Device Safety Issue?
A medical device safety issue is a malfunction or problem that affects health or contributes to injury. For example, a blood glucose meter can give incorrect blood glucose reading that leads to incorrect treatment planning. If a medical device poses a risk to safety and health, the use should be discontinued, and the problem should be reported to the healthcare provider.
Conclusion:
Medical devices play an important role in the therapeutic and diagnostic care of the patient. The innovative and advanced devices can contribute to improved patient care. Any risk related to the use of a device that is compatible with safety and health must be omitted. The basic concept in the development and design of a medical device should be considered for maintaining patient safety and to assure that it is not subjected to stress during normal circumstances.
