The medical equipment industry is amongst the most heavily regulated in Australia, and with good reason. Healthcare workers use any number of devices to diagnose and treat patients; these devices need to be of a certain standard to safeguard patient health and safety.

The Role of the TGA

The TGA — or Therapeutic Goods Association — plays an essential role in regulating the production and distribution of therapeutic goods in Australia. What is a therapeutic good? Simply put, it is any product that is used for the prevention, diagnosis, and treatment of a disease or injury.

The type of products that the TGA regulates therefore includes everything from herbal medicines to complex equipment used in a hospital setting.

The work of the TGA provides clinicians with full confidence that the products and equipment they are using to treat their patients work as intended and will not cause undue harm.

Overview of Medical Devices

One of the TGA’s main responsibilities is to monitor the development, product, and advertising of medical devices. The term ‘medical devices’ is all-encompassing, covering a wide variety of capital and consumable products.

To make this easier for equipment manufacturers and suppliers, the TGA has classified medical devices according to a range of criteria. This can be summarised as follows:

• Class I: Low risk, example being a bandage
• Class I — supplied sterile: Low-medium risk, example being a syringe
• Class I — incorporating measuring function: Low-medium risk, example being a measuring cup
• Class IIa: Low-medium risk, example being a thermometer
• Class IIb: Medium-high risk, example being a ventilator
• Class III: High risk, example being a joint replacement
• Active Implantable Medical Device: High risk, example being a defibrillator

The TGA provides a range of resources that are designed to assist companies that produce medical equipment in Australia meet their strict guidelines. They also play an active role in regulating these devices by providing both pre-market assessment and post-market assessment.

To be marketed and sold in Australia, all medical devices must be included on the Australian Register of Therapeutic Goods.

Paragon Care — An Experienced Provider of Quality, Approved Healthcare Products

As a leading provider of medical equipment in Australia, the team at Paragon Care possesses an in-depth, first-hand understanding regarding the importance of following TGA regulations. Our vision — to provide advanced solutions to improve patient experience and user workflows — demands that we supply our customers with equipment of the highest quality.

We understand that healthcare managers and clinicians hold a duty of care to their patients. In turn, we take our responsibilities towards our customers extremely seriously. Our product portfolio includes innovative capital and consumable products, supported by an extensive network of engineers across the Australia and New Zealand regions. Our values — which include integrity, transparency, accountability, teamwork, and a customer-focus — guide us in our quest to provide customers with quality healthcare equipment.

If you are looking for a supplier who understands regulatory guidelines and strives to provide customers with all the information they need to make an informed purchase, contact Paragon Care today.

The invention of the ultrasound in the 1950s completely revolutionised healthcare. Being able to view internal structures enabled clinicians to diagnose and treat patients far more efficiently without the need for invasive and painful internal operations.

Since then, the ultrasound has been adapted and utilised across a wide range of medical sectors. Urologists, in particular, have greatly benefited from access to ultrasounds, which have provided a wide range of urology solutions.

What is an ultrasound?

An ultrasound is a type of diagnostic scan that is used to examine internal body structures. Ultrasounds are typically associated with pregnancy but they are used to diagnose a wide variety of other conditions.

An ultrasound works by emitting high-frequency sound waves from a small, handheld device. These sound waves are reflected by the patient and received back by the device, forming a scanned image of the patient’s internal body.

Ultrasound scans are favoured as they are generally non-invasive — aside from obstetric, pelvic, and rectum examinations. These are conducted using specially designed probes. An ultrasound doesn’t require the use of dyes or radiation to diagnose a patient, and is an essential device used across all healthcare settings.

How are ultrasounds used in urology?

Urologists are concerned with conditions affecting the kidneys, bladder, prostate, and male reproductive organs. Such conditions typically include cancer, infection, blockages, and dysfunction — while the symptoms of these problems may be evident, it is difficult to diagnose without being able to look inside the body.

An ultrasound is an important diagnostic device that grants that interior perspective and can assist clinicians plan and implement treatment regimes.

When diagnosing conditions related to the prostate and male reproductive system, a probe is often used and inserted into the rectum. When studying the bladder and kidneys, a gel is spread over the skin (to help transmit sound waves) and the ultrasound is performed externally.

BK Ultrasound — premium ultrasound systems

Paragon Care are the official Australian partner for BK Medical, market leaders in urology, surgery, and endo-anal. BK Medical’s product portfolio features a wide range of innovative devices that produce images of unparalleled quality.

BK Medical has over 40 years experience producing equipment that assists clinicians make informed, real-time diagnostic decisions.

Using the latest technology, BK ultrasound systems seamlessly integrate with existing equipment, support robotic-assisted technology, and use advanced imaging modes — including elastography and contrast imaging — to assist clinicians effectively diagnose patients.

Paragon Care — your partner in urology solutions

Beyond ultrasounds, Paragon Care offers an extensive range of equipment, products and consumables that can be used to diagnose and treat urological conditions.

Treatment of cancers, blockages, and infections within the urological system has progressed tremendously over the past few decades. Clinicians are now able to offer non-invasive, effective laser and shockwave therapy options, which reduce patient recovery time.

Consumables are an important part of safe patient care. Products including needle guides and covers significantly reduce the risk of infection and make the clinical environment safer for both patients and healthcare professionals. Closed system transfer devices are also used by clinicians to reduce the risk of external materials contaminating drugs, and to protect healthcare workers themselves from coming into contact with hazardous substances.

Conditions associated with the urological system are often quite painful. Pain management products — including anaesthesia delivery systems, needle guides, and speciality covers — help patients who are in pain and reduce the risk of infection transmission.

Paragon Care’s range of products — including high-tech ultrasounds — are designed to provide urology solutions to all of your problems. Whether you require consumable or capital equipment, Paragon Care’s team of experienced professionals are here to assist. Contact us today to find out more.