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Medical devices and products have many advantages but need regulation for safe usage. The effectiveness of a device is determined by the regulatory laws set by the Australian Government’s health department for each class to ensure the product is safe for general use. Medical devices are available in different classes, depending on their characteristics and purpose.

What is a class 1 medical device? What are the products that fall into this category? What are the other classes for devices? Read on to learn more about the classifications of medical devices in Australia.

What Are Class 1 Medical Devices?

Class 1 medical devices are the ones that cause the least amount of harm for the user. Most devices in this class don’t need to abide by regulatory laws and are relatively safe to use. Roughly half the types of medical products fall into this category as they are simple in utility and functioning. They are subject to the least amount of regulation by the Therapeutic Goods Administration.

So, what is a class 1 medical device? Class 1 medical devices are considered to be very safe and require minimal authorization for usage. These non-invasive devices, which do not require piercing the skin, provide a high level of safety for users. Examples of Class 1 devices include gloves, masks, bandages, wraps and wheelchairs, among others, which can be used by consumers with confidence.

What Are the Main Products Under Class 1 category?

The major products under class 1 category are:

  1. Gloves
Gloves fall under the class 1 category when they are not sterilised. Latex gloves and nitrile gloves have many applications in the medical sector. Tattoo artists and laboratory technicians popularly use black nitrile gloves. Nitrile gloves are usually used once and disposed of to prevent the spread of harmful pathogens. They fit the wearer’s hand well and help perform intricate work. 

  1. Sterilisation wraps
Sterilisation wraps are specially designed sheets of material that are used to wrap medical equipment or instruments prior to sterilisation. These wraps are typically made from a non-woven, disposable material that is able to withstand the high temperatures and pressures used in sterilisation processes, such as steam or ethylene oxide sterilisation. Sterilisation wraps create a barrier that prevents microorganisms from contaminating the equipment or instruments during the sterilisation process, and also to maintain the sterility of the contents after sterilisation until they are ready to be used. Sterilisation wraps are available in different sizes and are designed to fit various types of medical instruments, including surgical instruments, dental instruments and endoscopes.

  1. Surgical masks
A surgical mask is used to protect the wearer from large-particle droplets, splashes and sprays that may contain infectious germs. It is also used to protect others from respiratory secretions that may be expelled by the wearer. A surgical mask is not designed to filter small airborne particles, such as those that can be found in aerosols or smoke. Whilst surgical masks are not as effective as respirators in preventing the transmission of respiratory infections, they can be an important tool in preventing the spread of germs, particularly in healthcare settings. Proper use of a surgical mask, along with other infection control measures, such as hand hygiene and social distancing, can help to reduce the risk of infection for both healthcare workers and patients. Other primary class 1 medical devices include bandages, bed pans, crutches and wheelchairs. Safe products are generally classified as class 1 and are not subject to extreme regulatory rules prior to their release to the market. 

What Are the Other Classes of Medical Devices in Australia?

More than half the medical devices don’t fall into the first class. Here are the other categories of medical devices which are commonly used in the industry:

  • Class IIa: Medium-risk devices, such as hearing aids and x-ray machines. These devices must meet basic safety and performance requirements and may be subject to some degree of testing and monitoring.
  • Class IIb: Higher-risk devices, such as infusion pumps and surgical instruments. These devices are subject to more rigorous testing and monitoring and must demonstrate a higher level of safety and performance before being marketed in Australia.
  • Class III: Highest-risk devices, such as implantable pacemakers and heart valves. These devices are subject to the most stringent regulatory requirements. Also, they must undergo extensive testing and clinical trials to demonstrate their safety and effectiveness before being approved for use in Australia.

The TGA regulates the release of these products and performs examinations to prevent potential harm from medical devices. Unlike class I, these classes involve products that need greater monitoring to ensure no side effects.

Dexcon | Leading Medical Device and PPE Supplier in Australia

Medical devices are divided into classes depending on the risk associated with the product’s intended usage and their invasiveness concerning their utility. Class I products carry minimal risk and require little compliance regulation. 

At Dexcon, we specialise in the manufacturing, distribution, consultation and procurement of medical products. We focus on customer experience to help you get the best products which fit your requirements. Contact us here and purchase quality medical products today.