As per FDA guidelines, all the medical products are classified into three classes as per the risk they possess so that proper safety precautions can be used.
In order to properly use medical devices, you need to understand what category it falls into. Medical syringes or hypodermic syringes are important medical devices.
It helps in blood tests as well as intramuscular injections. Insulin is injected into the body via syringes. It is used for vaccination as well.
Because of this, it is very important to understand the classification of syringes. If you don't know much about syringes, we can help. In this guide, we will explain you about medical syringes and show you what calls it falls under.
What Are Medical Syringes?
The medical field uses medical grade equipment that is not available for the home market or can only be found in speciality medical stores.
One such type of important medical grade equipment or device is syringes. It is a medical device that is usually used to inject fluids into an individual's body.
These syringes are used to perform many different procedures, including everything from injecting medicines to drawing blood. In every surgical procedure, syringes are used.
While some procedures require an entire set of equipment to complete, other simple procedures only require a syringe and needle Syringes are also used to inject filler materials into a patient's skin for aesthetic surgery.
Hypodermic syringes are used with hypodermic needles for different medical uses. In order to use a needle, you need to use a syringe.
Classification of Syringes:
Medical device classifications are a key process in identifying new medical products and ensuring their safety. It also helps to maintain the quality and superiority of medical products.
The devices are classified on the basis of safety, security, convenience, evidence-based decision support and practice standards.
Medical device classifications are determined by governing bodies such as Food and Drug Administration. To adhere to these regulations, medical device classification plays an important role.
Health officials at the Food and Drug Administration may classify syringes based on whether or not they have been sterilized. Manufacturers themselves may create their own sets of classifications for syringes based on how they are produced and what they contain.
As syringes can transmit diseases due to needlestick, so it is classified into class 2 medical devices. These are moderate to high-risk devices.
Class 1: These are medical devices with low risk. Nearly 47% of medical devices come into this category. Most of the devices are exempted from regulation as they are low risk. Examples are bandages, oxygen masks, electric toothbrushes, etc.
Class 2: These medical devices contain moderate to high risk. Nearly 43% of medical devices fall into these calls. Medical syringes used with needles fall into this class as they pose a risk of spreading infection and diseases from contaminated blood.
Class 3: These are high-risk medical devices. They can pose a very high risk to the life of the patient. Nearly 10% of medical devices fall into this category. It includes pacemakers, ventilators, breast implants, etc.