BCS Testing: Medical Device Testing & Calibration - Blog #Services

Why is it important to test and tag medical devices?

Tue, 27 Feb 2024 10:12:35 +1100

From electrocardiograms to infusion pumps, all devices in your clinic are vital to giving the patients the best care. As with any electric device, medical devices can also be a potential hazard to the patient when the equipment’s safety status is unknown. This is where test and tag services prove essential for ensuring electrical equipment safety in workplaces and homes. They involve a thorough inspection of electrical equipment to identify any potential hazards and the application of tags to indicate the equipment's safety status.

In the healthcare world, where every moment is critical and every procedure demands precision, the reliability of medical devices is non-negotiable. At BCS Testing, we understand the gravity of this responsibility, especially in rural and regional Australia where access to services can be challenging. Since our establishment in 2003, we have been on a mission to provide professional and cost-effective testing and calibration services to ensure the safety and efficiency of medical equipment.

Discover the core elements of our testing and tagging service through these five key points. Gain insights into the essence of what makes our service reliable and efficient for your needs.

Why test and tag medical devices?

Medical devices play a vital role in patient care, diagnosis, and treatment. Ensuring they function optimally is not just a regulatory requirement but a moral obligation to uphold patient safety. Please take a look in why you should test and tag your equipment:

Compliance with standards

Regulatory bodies set stringent standards for the calibration and testing of medical devices. Compliance with these standards is not just a checkbox exercise; it is a guarantee that the equipment meets the necessary criteria for safety and performance. Our commitment at BCS Testing is to navigate the vast landscape of rural and regional Australia to bring compliance to your doorstep.

We follow the Aussie Standard AS 3551 closely in our testing and tagging efforts. This standard serves as a comprehensive guide for the management and maintenance of medical devices, encompassing calibration procedures, testing protocols, and quality assurance practices.

Patient safety

Faulty or inaccurately calibrated medical devices can pose serious risks to patient safety. From misdiagnosis due to inaccurate readings to complications arising from malfunctioning equipment, the consequences can be severe. Testing and tagging ensure that these risks are minimised, creating a safer healthcare environment for both patients and practitioners.

Prolonged equipment lifespan

Medical devices are substantial investments for healthcare facilities, and their longevity is crucial. Regular testing not only identifies potential issues before they escalate but also contributes to the longevity of the equipment. This translates into cost savings for healthcare providers, allowing them to allocate resources more efficiently to mitigate risks and systematically assess potential failure modes and their effects on medical devices.

Legal and ethical responsibilities

Healthcare providers have legal and ethical responsibilities to ensure that the equipment they use meets the required standards. Testing and tagging fulfil these obligations, providing a robust defence in case of any unforeseen events. It's a proactive approach that reflects a commitment to excellence in patient care.

Regulatory documentation and audits

Our testing processes are accompanied by comprehensive documentation. This documentation serves as a critical resource during regulatory audits, providing a transparent record of the testing procedures undertaken, calibration results, and any corrective actions implemented.

Why BCS Testing?

At BCS Testing, we take pride in being the guardians of this reliability, bringing our services to you, wherever you may be. Because in healthcare, there are no compromises when it comes to the safety of those we serve.

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Understanding everything about us. A deep dive into BCS Testing's test and tag service

Tue, 27 Feb 2024 10:12:35 +1100

We understand that booking a test and tag service isn’t at the top of your priority list, considering the many things happening in your clinic. However, it is a requirement of RACGP for accreditation and a crucial action to prevent any potential harm to patients and staff.

So, let us explain why this is so important and how we can take the stress out of your hands.

Why test your medical equipment under the AS3551 standard?

To comply with the RACGP requirement.

To ensure the well-being of your patients and staff by preventing burns, electric shock, or in rare cases, even serious injury or death.

To uphold the integrity of medical equipment.

Let us handle this for you…

Our team offers a seamless solution for your test and tag needs.

Easy booking

You can fill out a form, call or email us anytime to book your first or next appointment.

Efficient reporting

Our dedicated technicians generate detailed reports within three weeks after completing the service.

On-time service

We always show up on time according with your needs. Count on us to always be aligned with your schedule and ensuring minimal disruption to your operations.

Easy re-booking

You stay organized receiving an email reminder from us three weeks before your overdue date.

We come to you

Don’t worry about logistics, we test everything in your site with no travel fee. We understand the unique challenges of rural areas, and our technicians embark on annual or semi-annual trips to cover these regions.

Who should have the equipment tested for AS3551?

Any organization or individual providing medical diagnosis, treatment or monitoring. This includes hospitals, medical centers, physiotherapy clinics and medical and dental surgeries.

What equipment do we test under the AS3551 standard?

Australian Standard 3551-2012 ‘Management Programs for Medical Equipment’ requires that certain devices used in medical practices be tested once every 12 months. This testing is more rigorous than the Tagging and Testing required for non-medical devices. AS 3551 requires both safety and performance measurement or verification. Devices that require testing to AS 3551 include:

Medical equipment

Blood pressure monitor
ECG
Nebuliser
Electric beds
Pulse oximeter
Spirometer
Suction pump
Hyfrecator / Diathermy
Cast saw
Audiometer
Examination lamp
Cautery unit
Defibrillator
Infusion pumps
Lasers

Physiotherapy equipment

Ultrasound units
Electric beds
Interferential devices
Suction units
Hot pack units
Treadmill
Laser units
Traction units
Magnetic therapy unit
Cast saws
TENS units
Shortwave units
Paraffin baths
And a lot more…

What is the test and tag process?

When the scheduled day arrives, our technician will be equipped with the necessary "test machines" to meticulously inspect and tag all your medical and electrical equipment. A brief tour to the practice helps ensure that every relevant item is covered. We understand the hustle of a busy practice, but rest assured, our technicians are adaptable and can work around practice schedules, providing flexibility to accommodate operational needs.

What other services do we offer?

We do AS 3760-2010, it provides a standard for the 'In-service safety inspection and testing of electrical equipment'. These tests are mandated annually in most states. Devices that require testing to AS 3760 include:

Microwave Ovens
Electric Jugs
Portable Lamps
Computers
Portable Heaters
Extension Cords
Portable Electrical Hand Tools
Refrigerators
Portable Fans
Toasters
Electric Frypans

We also provide service doing Australian Standard 3003-2018 'Electrical installations — Patient areas', it specifies “safety requirements for electrical installations in areas where it is intended that low-voltage medical electrical equipment will be used on a patient. It applies to new electrical installations and to alterations, additions and repairs of existing electrical installations.

What is the difference between Medical Electrical Safety Testing and safety testing of other appliances?

The testing requirements for medical electrical appliances under AS3551 are more detailed and extensive than for appliances in general use. General appliance testing is insufficient for fulfilling the obligations of a medical practice.

What locations do we go to?

Our commitment to rural and regional Australia takes us to many locations. From the vast expanses of the outback to remote communities, we bring our test and tag services directly to those who need it the most. We understand that access to services is not readily available in these areas, and that's precisely why our testing teams embark on wide loops through designated parts of the country.

From Cairns to Adelaide, depending on where the clinic is located, we will be passing by your town at least once a year.

Here are some of the small and big towns we go:

Roma, Longreach, Richmond, Allingham, Ingham, Mareeba, Cairns, Halifax, Townsville, Ayr, Bowen, Proserpine, Rockhampton, Gladstone, Bundaberg, Bundaberg, Hervey Bay, Maryborough, Gympie, Noosa, North Brisbane, Gatton, Toowoomba, Stanthorpe, Warwick, Kyogle, Lismore, Alstonville, Evans Head, Yamba, Maclean, Grafton, Armidale, Uralla, Wee Waa, Lightening Ridge, Coonamble, Baradine, Gunnedah, Tamworth, Glenn Innes, Sydney, Coffs Harbour, Yamba, Goonellabah, South West Rocks, Kempsey, Bellingen, Port Macquarie, Newcastle, Muswellbrook, Scone, Mudgee, Yeoval, Orange, Canowindra, Portland, Lithgow, Blackheath, Katoomba, Hazelbrook, Springwood, Lawson, Blaxland, Nowra, St Georges Basin, Milton, Ulladulla, Mittagong, Goulburn, Young, Cootamundra, Tumut, Cooma, Jindabyne, Mount Beauty, Wangaratta, Yarrawonga, Shepparton, Mansfield, Warburton, Grovedale, Geelong, Colac, Terang, Mount Gambier, Millicent, Robe, Kingston, Lucindale, Padthaway, Naracoote, Oakbank, Angaston, Balaklava, Port Augusta, Berri, Mildura, Swan Hill, Deniliquin, West Wyalong, Forbes and etc…

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Elevate your compliance standards with our new AS5369 Autoclave Validation Service

Tue, 27 Feb 2024 10:12:35 +1100

What is AS5369 Autoclave Validation, and why does it matter?

AS5369 sets the gold standard for autoclave performance and annual compliance. Our validation procedures adhere meticulously to AS5369 standards, ensuring that your autoclave systems meet the highest industry benchmarks. By choosing our AS5369-compliant validation, you are investing in the highest level of precision, reliability, and compliance for your sterilization processes.

Key benefits of our AS5369 Autoclave Validation Service:

Comprehensive compliance
Our validation processes align seamlessly with AS5369 standards, giving you confidence in the regulatory compliance of your benchtop sterilizer.
Precision and accuracy
We utilize cutting-edge technology and a team of experts to conduct thorough validations, guaranteeing precision, accuracy, and repeatability.
Transparent documentation
Receive detailed, AS5369-compliant validation reports, providing a transparent record of the entire process for regulatory compliance and internal quality assurance.
One stop shop
When you add our autoclave validation to your usual test & tag service, you organize AS3551 and AS5369 compliance in 1 booking, and you don’t receive any additional travel fees!

Ready to utilize our expertise for your Autoclave performance verification?

Elevate your compliance standards and ensure the utmost reliability in your operations. To schedule your AS5369 Autoclave Validation or to learn more about our comprehensive services, please contact us at contact@bcstesting.com.au

Don't compromise on quality. Validate your autoclave with confidence!

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Australian Standards and Safety Compliance for Medical Clinics

Tue, 27 Feb 2024 10:12:35 +1100

In Australia we have standards and guidelines for medical clinics that should be followed to help minimize risk and increase patient safety.

The importance of patient safety

In any healthcare environment, patient safety and user safety is of the utmost importance. In a setting where the objective is to heal patients, there are hazards and risks involved that we should be aware of. In Australia we have standards and guidelines for medical clinics that should be followed to help minimize risk and increase patient safety.

Do you own a medical practice?

Are you in a practice manager's role?

Are you looking to gain practice accreditation?

Do you use electromedical equipment to treat or diagnose patients on a daily basis?

... If you answered yes to any of these, then this guide is most applicable to you, so please read on. We will cover the Australian Standards for:

Medical Device Safety - AS/NZS 3551:2012

Electrical installation safety - AS/NZS 3003:2018

Autoclave validation - AS/NZS 4815:2006

General Test & Tag - AS/NZS 3760:2022

A typical surgical patient care environment

Do these standards apply to me and my practice?

Oftentimes it can be difficult to determine which standards need to be followed in a medical setting, or if any at all. Especially when there are a broad range of patient care environments - Cardiology, Surgical, General Practice, Dental, and so on.

Typically, each type of medical practice has their own set of guidelines to follow. For example the RACGP produce the core guidelines that should be followed by all general practices, and the NSQHS standards are for all day surgery, hospital and dental clinics.

However, no matter which guidelines your clinic is directed by, each standard has the same goal: to reduce risk and increase safety for both the caregiver and the one being cared for.

From a biomedical engineers perspective, there are 3 core Australian standards we must observe to ensure we are reducing risk and increasing safety in an environment where electromedical equipment are being used. These are sometimes referred to collectively as the 'patient safety triangle':

It is important note that everyone has a part to play in reducing risk of patient harm. If you work in a patient care environment, you should be aware of all potential electrical hazards, and how to reduce the risk of patient harm.

AS/NZS 2500:2020 - Safe use of Electricity in Patient Care

First and foremost we will observe the Australian guide to patient safety in healthcare environments. This standards provides the framework in understanding the risks involved as well as procedures to increase safety.

It is important note that everyone has a part to play in reducing risk of patient harm. If you work in a patient care environment, you should be aware of all potential electrical hazards, and how to reduce the risk of patient harm. There is no annual compliance test that is needed under this standard, however it governs the next two standards which will require annual testing.

AS/NZS 3551:2012 - Safe Management of Medical Equipment

Under this standard, we will make sure that all medical devices in the clinic are safe from defects that could cause electric shock. We will also verify the correct operation of the equipment's safety functions, in the case of an electrical fault. We are also checking that the equipment are in line with defined acceptance criteria from the standard and performing to the manufacturer's specifications.

If you are opening a new practice and have purchased new capitol, you will want to make sure those have had acceptance tests to ensure they are electrically safe and performing as intended. Over time, medical equipment will degrade due to wear and tear, so it is best that the equipment is re-checked every 12 months.

AS 3003:2018 - Safe Electrical Installations

In the previous standard, we ensure safety of medical equipment. In this standard, we will ensure the power point installations are also safe. This standard outlines how the electrical wiring should be installed in the practice. These guidelines will be followed by your electrician when you decide to build or make renovations to your practice.

The installation will either be made as body-protected or cardiac-protected, depending on what kind of medical procedures take place in the rooms. The electrical installations will be made with circuit protective devices, mainly residual current devices (RCDs). In the event of an electrical fault, these RCDs should cut off the supply of electricity, protecting your equipment, and more importantly, people's lives.

You may want to reduce risk in your practice, by having your electricals commissioned upon installation and then re-validated every 12-months.

Further standards for Medical Practices

AS 4815:2006 - Validation for Steam Sterilisers

Validation is a mandatory process described by Australian standard (AS/NZS 4815:2006) that should be undertaken upon installation and then at least once every year on your autoclave. This process is a legal obligation to ensure that your autoclave is sterilising correctly and removes the risk of cross contaminant diseases being passed to your patients. To find out more, please click here .

AS 3760:2022 - Safety Tests for General Electrical Equipment

Further to the requirements of having medical equipment tested and tagged, you may want to have all the general electrical equipment tested also. Under this standard, all equipment that plugs into the wall will be safety inspected and tested. If you require to have all the electrical equipment tagged, it is practical to have it done at the same time as the testing of the medical equipment.

In Summary

There are two main ways to ensure safety in the practice:

Safe Medical Equipment - AS/NZS 3551:2012: as a baseline you should have all the medical equipment in the practice tested every 12 months.
Safe Electrical Installations - AS/NZS3003:2018: If you are testing your equipment, it also makes sense to test and verify the electrical installations of the practice.

Further to the standards for medical safety, you may be required to follow:

Autoclave Validation - AS/NZS 4815:2006: If your practice has an autoclave steam sterilizer, it must be validated and serviced every 12 months.
General Electrical Test & Tag - AS/NZS 3760:2022: You may want to have all the other electrical equipment in the practiced verified according to this standard.

If you like to book in a service with StarkMed, please call us or complete our contact form with your requirements.

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