Category: Patients

FACT SHEET – ATRIAL FIBRILLATION

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What is atrial fibrillation and how common is it?

Atrial Fibrillation (also known as AF) is a prevalent and dangerous arrhythmia problem that affects almost half a million Australians. (AF) is a heart condition whereby the top chambers of your heart (the atria) beat fast and erratically. In Atrial Fibrillation, your heart may not pump blood around the body as well as it should. If left untreated, AF may lead to serious health complications, such as stroke and heart failure.

Why is AF a problem if it’s left untreated?

In people with atrial fibrillation, blood may become trapped in the heart chambers and cause a clot. This blood clot can then travel to the brain, blocking the blood supply to the brain and causing a stroke.

People with atrial fibrillation are five-to-seven times more likely to suffer a stroke, and three times more likely to develop heart failure. For this reason, early diagnosis and appropriate treatment are essential. There are a number of treatment options available to help manage symptoms and lower your risk of heart failure and stroke. Many people with atrial fibrillation have no symptoms, but others experience a racing heart, thumping in the chest, chest pain or discomfort, fatigue, tiredness, loss of breath, or dizziness.[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]

What is happening during Atrial Fibrillation Awareness Week?

As part of AF Awareness Week, hearts4heart is setting up testing stations in hospitals, PG Clinics and pharmacies across the nation for free testing for Atrial Fibrillation. This is a wonderful opportunity for people to have comprehensive screening for AF in addition to assessing their risk of developing AF. However, we encourage Australians, particularly for those over the age of 65 to visit their GP for regular screening for AF to reduce the risk of stroke. We encourage all Australians to visit one of our sites providing free screening during AF Awareness Week to reduce your risk of Stroke. You can visit the Hearts4Hearts website at hearts4heart.org.au for a full list of locations.

Why is it so important to be screened for AF?

30% of people living with AF are undiagnosed and are at risk of stroke. For people living with atrial fibrillation, the risk of stroke is 5-6 times greater than the general population and up to 80% of these strokes are preventable.

What final message do you have for the community to coincide with Atrial Fibrillation Awareness week?

While AF can affect anyone at any age, the risks increase as you get older.  The most common causes of atrial fibrillation are abnormalities or damage to the structure of the heart over time because of a heart attack or long-term high blood pressure, heart disease, diabetes, sleep apnoea or obesity. Managing lifestyle factors such as limiting alcohol intake, stopping smoking, managing a healthy diet and regular physical activity can significantly reduce the risk of developing AF.

Finally, we also encourage Australians and in particular medical professionals to visit the Heart Foundations’ website for the new Australian AF Clinical Guidelines recently launched at the Cardiac Society of Australia and New Zealand annual conference.[/vc_column_text][/vc_column][/vc_row]

CHRONIC PAIN CONCERNS OVER PHI REFORMS

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[vc_row][vc_column][vc_column_text]On September 11 the Private Health Insurance Legislation Amendment Bill 2018 (the Bill) and two related Bills passed the Parliament.

The legislation implements a package of reforms around private health insurance, they include:

  • allowing for age-based premium discounts for hospital cover
  • allowing private health insurers to cover travel and accommodation costs for regional Australians as part of a hospital treatment
  • strengthening the powers of the Private Health Insurance Ombudsman
  • improving information provision for consumers
  • reforming the administration of second tier default benefits arrangements for hospitals
  • allowing insurers to terminate products and transfer affected policy-holders to new products
  • increasing maximum voluntary excess levels for products providing individuals an exemption from the Medicare levy surcharge and
  • removing the use of benefit limitation periods in private health insurance policies.

The Minister for Health, Greg Hunt MP, announced these reforms will make private health insurance simpler and more affordable.

“This new approach will take all existing private health insurance policies and categorise them into a four-tier system – Gold, Silver, Bronze and Basic,” Mr Hunt said.\

Following the passage of the legislation, pain groups have cautioned about potential unintended consequences of placing chronic pain in the highest category of cover.

Changes to the clinical category intended as part of the reforms could disproportionally impact patients with chronic pain and may have far reaching implications for millions of privately insured consumers who rely on existing coverage to access chronic pain management.

Advocacy group Painaustralia has urged the Commonwealth to reflect concerns its members have raised in the rules currently being drafted to give effect to the reforms in the legislation.

Painaustralia’s CEO, Carol Bennett said she welcomed the broad intention of the reforms to simplify private health insurance but cautioned against reforms that could create a situation that forced vulnerable people to drop their health insurance altogether.

“It’s important that [the legislated reforms] don’t negatively impact on people living with chronic pain who are some of the most vulnerable in our community and often unable to work,” Ms Bennett said.

These concerns were also noted by Senator Helen Polley and Senator Richard Di Natale during the second reading of the Bill, with both nothing the changes to clinical categories could adversely impact millions of consumers.

“These rules are not detailed in these bills. Those details are apparently going to come later in the form of regulation. The government claims its new gold, silver and bronze basic system will make private health insurance simpler and more affordable. It also claims that the changes will give consumers more clarity and certainty around their coverage,” Senator Polley said.

Chronic pain is the most common reason that people seek medical heal and one in five Australians live with chronic pain. Pain is also common to many chronic conditions and its impact spans the health, disability and ageing systems.[/vc_column_text][/vc_column][/vc_row]

MY HEALTH RECORD SYSTEM GETS ADDED PRIVACY PROTECTIONS

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[vc_row][vc_column][vc_column_text]. The Bill will specifically:

  • remove the ability of the My Health Record System Operator to disclose health information in My Health Records to law enforcement agencies and government agencies without an order by a judicial officer or the healthcare recipient’s consent; and
  • require the System Operator to permanently delete health information stored in the National Repositories Service for a person if they have cancelled their registration with the My Health Record system – that is, they have cancelled their My Health Record.

These amendments are the result of concerns expressed by some healthcare and privacy advocates that the MHR Act permitted the release of information to law enforcement agencies and other government bodies.

On 31 July 2018 the Minister for Health announced his intention to strengthen the MHR Act to make clear that information will not be released without a court order, and that My Health Record information would be permanently deleted if someone cancels their My Health Record.

Former AMA President Prof. Kerryn Phelps reinforced the view that it would be worth a rethink in terms of the technology given how much it has changed.

“We need to think about how far technology has come and how much we’ve learnt about cybersecurity in the meantime. Then I think that we could possibly look at what data would necessarily need to be uploaded so that it could be used in a de-identified way for public health benefit. What I’m seeing in here is much less about the personal benefits of the My Health Record and a lot more about privatisation, monetisation and public health benefits. I think we would all want to see public health benefits—things like containment of epidemics and tracking flu epidemics—but I don’t think any of us wants to see the potential costs in terms of privacy,” Prof Phelps said.

Dr Linc Thurecht, Senior Research Director at the Australian Healthcare and Hospital Association while welcoming the proposed changes also identified the wider healthcare benefits of My Health Record.

“We see it as a vital part of the future health infrastructure to provide better coordinated care for individual patients and to improve safety and quality in their care. For that to happen—I’m not sure if ‘critical mass’ is quite the right phrase—the more people who are part of that, the greater the opportunity there is to reap those kinds of benefits,” Dr Thurecht said.

Ian Burgess, CEO of MTAA believes the development of My Health Record will provide a tremendous opportunity to improve data collection across the whole health system and across the patient journey.

“We believe the government should prioritise consideration of the inclusion of medical device data in the My Health Record,”

“This would allow for improved post-market surveillance. While registries can be invaluable they’re complex and expensive. Ultimately, My Health Record should be the main data infrastructure system, rather than maintaining separate data collection systems,” Mr Burgess said.

The ADHA said in a statement that it welcomes the discussion and will be contributing to the inquiry.

“The Australian Digital Health Agency has been engaged in an important national conversation around My Health Record – its benefits, privacy controls and security protections. As the system operator responsible for the expansion of this system, the ADHA welcomes this discussion,” the statement said.[/vc_column_text][/vc_column][/vc_row]

IMAGING SOLUTIONS: PHILIPS SIGNS STRATEGIC PARTNERSHIP

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[vc_row][vc_column][vc_column_text]Under the terms of the two agreements, Philips will provide delivery, upgrade, optimisation, replacement and maintenance services for all major medical imaging solutions.

The partnerships will support precision diagnosis and therapy and drive operational performance across nine hospital sites. This managed service delivery model for medical imaging technology is the first-of-its-kind for Philips in Australia and the ASEAN Pacific region.

Philips will structurally manage the Local Health Districts’ entire inventory of diagnostic and interventional medical imaging equipment and clinical informatics solutions, including those of other vendors, across various clinical areas including radiology, cardiology and nuclear medicine. It will also provide financing services.

Through the partnerships, Philips will help to deliver on the core objectives of each Local Health District: enhancing the patient experience, managing population health, and maintaining responsible and predictable budget management to deliver the right care, in the right place, at the right time.

“These long-term strategic agreements will allow us to innately support our partners’ objectives of providing outstanding, innovative and future-proofed healthcare to their communities, by making them better informed, more efficient and more sustainable,” said Caroline Clarke, CEO Philips ASEAN Pacific.

“This first-of-its-kind service delivery model for Philips in Australia highlights how we are transitioning to becoming an integrated solutions and services provider that teams up in a shared framework to accelerate change in a new era of value-driven care.”

As part of the collaboration, Philips will also support the two Local Health Districts with its integrated data analytics solution, PerformanceBridge Practice.

This service aggregates and connects data from across different imaging modalities and information systems and provides actionable insights into departmental operations to help drive continuous improvement.

Next to this, each Local Health District will be able to monitor and optimise radiation exposure to both patients and their caregivers with DoseWise Portal, a radiation dose management solution.[/vc_column_text][/vc_column][/vc_row]

WORLD-FIRST STUDY INTO COCHLEAR IMPLANTS AND IMPACT ON SPEECH

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[vc_row][vc_column][vc_column_text]In the study, published today in the journal Ear & Hearing, the experts have found a correlation between a computer model and the speech intelligibility in implant recipients. This might mean that by improving the performance of the model, the performance of individuals with cochlear implants may benefit in ways that have never before been explored.

“Cochlear implants are remarkable devices that have changed lives over the past several decades,” said lead author, PhD candidate Greg Watkins from the University of Sydney’s School of Aerospace, Mechanical and Mechatronic Engineering.

“However, despite this astonishing history, listening to and understanding another person’s speech when there is a lot of background noise is still much more difficult for people with cochlear implants than it is for people with normal hearing.”

Greg, who received a cochlear implant himself in February, explained that: “Computerised speech intelligibility models are powerful tools that allow us to evaluate how a hearing impairment may affect a cochlear implant recipient’s ability to understand speech in background noise.”

The researchers compared the accuracy of four different models of a recipient’s likelihood to understand speech. They discovered that a new model, known as the ‘output signal to noise ratio’ or OSNR was superior in predicting the improvements or decline in sentence recognition of actual cochlear implant recipients.

“The OSNR appears to have the capability to predict what will happen as a result of changing the parameters available to clinicians when tailoring the implant performance to the specific needs of a patient,” said Professor Gregg Suaning, a global leader in implantable bionics from the School of Aerospace, Mechanical and Mechatronic Engineering and co-author of the study.

“The result might be that changes that were never considered as possible improvements may now be used to achieve a better outcome for recipients of cochlear implants.”

Brett Swanson, Principal Research Engineer at Cochlear Limited, highlighted another important aspect of the study.

“A cochlear implant stimulates the auditory nerve directly, so if you’re a researcher with normal hearing, you can’t listen to it yourself. Instead, we rely on dedicated volunteers with cochlear implants who spend hours in sound-proof rooms listening to sentences in noise and telling us what they hear. It is vital work, but mentally draining. OSNR has the potential to drastically reduce the amount of time that we need from our volunteers,” he said.

The next steps in this work include working with cochlear implant recipients to make changes in their implant based on the model predictions and demonstrating the outcome is indeed an improvement in speech recognition in noise.[/vc_column_text][/vc_column][/vc_row]

DIAGNOSTIC DEVICE CAN HELP PREVENT STROKES AND HEART ATTACKS

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[vc_row][vc_column][vc_column_text]Millions of people around the world die from heart attacks and strokes every year.

Predicting the formation of a blood clot is challenging because of the dynamic environment in which a clot forms. Blood platelets, which are a tenth of the size of a regular cell, are the major drivers of blood clot formation and they clump together within seconds when triggered.

ANU biomedical engineer Dr Steve Lee, from the ANU Research School of Engineering, and biochemist Associate Professor Elizabeth Gardiner, from the John Curtin School of Medical Research (JCSMR), are the research team leaders.

“Using the new diagnostic device that our team has developed, we can create and quantify clot formation in 3D view from a blood sample without any form of labelling such as fluorescence or radiotracer – this had been impossible to achieve until now,” Dr Lee said.

Associate Professor Gardiner said that doctors treated people at risk of heart attack or stroke with blood-thinning medication, but there was no way to know a patient’s susceptibility with precision – until now.

“We can apply this technology to blood from patients at risk of clotting or uncontrollable bleeding – this is a potential gamechanger,” she said.

Sherry He, a CSC-PhD scholar in Dr Lee’s group at the ANU Research School of Engineering, and Dr Samantha Montague, a postdoctoral fellow from the Gardiner group at JCSMR, supported the development of the new diagnostic device.

“Our device creates a digital hologram of a microscopic blood clot at a fraction of a second by measuring the delay time for light to travel through the clot,” Ms He said.

The team tailored a microfabricated device that can mimic a damaged blood vessel and created blood clots from human samples to reveal these blood-clotting events in the laboratory.

Ms He said the device can be fitted onto a regular microscope, but was not yet suitable to be used at the bedside.

“We need to shrink our diagnostic device, which takes up a fair amount of space in a research lab at the moment, to something that can fit into a shoebox so that it can be used in a clinical setting,” she said.
Dr Montague said the device would be further developed in tandem with existing clinical and platelet research practices.

“We have set up this new diagnostic device at JCSMR right alongside routine flow cytometry equipment that are the gold-standard for cell and blood platelet analysis,” she said.[/vc_column_text][/vc_column][/vc_row]

PULSELINE FACT CHECKS THE ABC CLAIMS

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[vc_row][vc_column][vc_column_text]It’s incorrect to say the regulatory environment in Australia has not changed. In 2014 an extensive review of Medicines and Medical Devices Regulation was undertaken by a panel of three eminent experts that included Emeritus Professor Lloyd Sansom AO.

That Panel made 58 recommendations, with the Government supporting 56 of them. Since then a series of legislative reforms has been put in place to regulate medical devices.

The TGA is regarded as one of the most thorough of any agency around the world and has undertaken extensive reforms of medical devices. Its rigorous premarket requirements for medical devices are aligned to international best practice.

ABC has now carried several biased and misleading articles questioning the value of the medical technology industry to the Australian healthcare system.

Global advances in medical technology over the past 20 years have resulted in a 56% reduction in hospital stays, 25% decline in disability rates, 16% decline in annual mortality and increased life expectancy of approximately 3.2 years.

The story failed to recognise doctors and other healthcare professionals are the primary users of medical technology and the industry provides physicians the tools they need to improve patient care. To ensure better outcomes for patients, surgeons need training and familiarity with medical devices.

The rapid innovation which is the hallmark of the medical technology industry – and which serves to benefit patients – would not be possible without the close collaboration between physicians and companies.

Indeed, some of the most significant medical technology breakthroughs in the last 50 years have originated with physicians who saw an unmet patient need or way to improve an existing procedure and brought their idea to a manufacturer to refine and produce for a wide patient audience.

Unlike pharmaceuticals, medical devices are implanted by surgeons and need to last for years, the more familiar a doctor is with a device, the better the outcome for the patient. That’s why medical technology companies provide extensive education and training (or retraining) of surgeons.

It’s also why technicians often support surgeons in the procession of instruments used ensuring they are all in place, and with their order of use. Technicians are highly trained specialists with intimate knowledge of the medical device being implanted and the tools used during that surgery.

PulseLine will continue to take a close look at the reporting of other media outlets and will call out errors, misrepresentation and bias. [/vc_column_text][/vc_column][/vc_row]

KING TAKES RECORD TO SENATE

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[vc_row][vc_column][vc_column_text]Last week the Government announced it will amend the 2012 legislation, introduced by the then Labor Government, to ensure that if users wish to cancel their record they will be able to do so permanently, with their record deleted from the system forever.

These amendments come following concerns raised by several stakeholders since the announcement of the opt-out period, including the Australian Medical Association and the Royal College of General Practitioners who both requested the Government extend the opt-out period to give Australians more time to consider their options.

Uncertainty around the security and privacy of Australians’ having their health data being stored on a central government system had dogged the Government, as more than 20,000 Australians opted-out of the system in the first day.

The Government has attempted to reassure the public their data would be secure using the My Health Record, citing the success of the 6 year pilot program, which the Government says remained secure. The Health Minister also confirmed that the amendments to the legislation will ensure no records can be released to police or Government agencies, for any purpose, without a court order.

The Government has said its amendments will help strengthen the legislation to match the existing Australian Digital Health Agency policy. However, the Opposition remains unconvinced.

Shadow Health Minister, Catherine King MP, says the Opposition remains deeply concerned about the way the Government has handled the My Health Record opt-out period, claiming it has severely undermined the public trust in the reform.

Ms King believes that while the Government has agreed to a number of changes demanded by the Opposition and doctors’ groups, including an extension of the opt-out period and a new public information campaign, more needs to be done.

The Opposition will seek crossbench support to refer the rollout to the Senate Finance and Public Administration References Committee, which could also inquire into the census failure and the sale of Medicare numbers on the darkweb.

Ms King said the inquiry will examine the Government’s decision to shift from an opt-in system to an out-out system and whether it adequately prepared for this fundamental change from Labor’s system.

“[The inquiry] will examine a range of privacy and security concerns, including the adequacy of the system’s log-in procedures and default settings. It will also consider issues raised in the public domain around domestic violence and workers’ compensation,” Ms King said.

“Labor remains of the view the Government should suspend the My Health Record rollout until this mess can be cleaned up.”

It is expected that the committee will be asked to report back on its findings before the end of the opt-out period in mid-November.[/vc_column_text][/vc_column][/vc_row]

MY HEALTH RECORD OPT-OUT PERIOD EXTENDED

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[vc_row][vc_column][vc_column_text]This was a key request from the Australian Medical Association and the Royal College of General Practitioners and gives Australians more time to consider their options as we strengthen the 2012 My Health Record legislation.

The Government will amend the 2012 legislation to ensure if someone wishes to cancel their record they will be able to do so permanently, with their record deleted from the system forever.

This means any Australian will be able to opt-out of the system permanently, at any time in the future, with their record deleted for good.

The government has said it will also strengthen the legislation to match the existing Australian Digital Health Agency policy.

This policy requires a court order to release any My Health Record information without consent.

The amendment will ensure no record can be released to police or government agencies, for any purpose, without a court order.

The Australian Digital Health Agency’s policy is clear and categorical – no documents have been released in more than six years and no documents will be released without a court order. This will be enshrined in legislation.

As the Australian Digital Health Agency has already stated, contrary to incorrect claims made by unions this week, under the Healthcare Identifiers Act 2010, specifically subsection 14(2), healthcare providers cannot be authorised to collect, use or disclose a healthcare identifier, and as a consequence access a patient’s My Health Record, for employment and insurance purposes.

Under the Act it is expressly prohibited and using or disclosing a healthcare identifier without authority is an offence and subject to severe penalties, including two years in jail and a fine of $126,000.

Last week in Alice Springs all health ministers unanimously reaffirmed their support for My Health Record, the national opt-out approach and our steps to strengthen the legislation.

Minister for Health Greg Hunt said he welcomed the bi-partisan support from both Labor and Liberal state governments for this important health reform.

As health ministers noted at the meeting, the expert clinical advice is that My Health Record will deliver better health care for patients.

The Government will also work with medical leaders on additional communications to the public about the benefits and purpose of the My Health Record, so they can make an informed choice.[/vc_column_text][/vc_column][/vc_row]

DIGITAL HEALTH A $200 BILLION INDUSTRY BY 2020

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[vc_row][vc_column][vc_column_text]Software and technologies that assist in diagnosis, treatment options, storing and sharing health records, and managing workflow can enable more efficient clinical practice. The proliferation of digital health tools, including mobile health apps and wearable sensors, holds great promise for improving human health.

By some accounts there are now over 318,000 health apps available on the top app stores worldwide, nearly double the number of apps available in 2015 – with more than 200 apps being added each day.

In today’s environment, apps can be created by anyone with a good idea and some programming skills.

When barriers to entry are low, how do you differentiate yourself? But more importantly how does the industry and regulators ensure the quality of the technology can be directly linked to clinical evidence sufficient to demonstrate an appropriate level of safety and performance when used for the intended purpose.

That’s why this week the TGA recognised that to continue providing a clear regulatory environment for medical devices in Australia, it is essential that it engage with the medical devices ecosystem during the development of new regulatory recommendations and guidelines. The TGA has commenced consultation, through CSIRO Futures, in the areas of Software as a Medical Device (SaMD), and Cyber Security for Medical Devices (CSfMD).

As with all other medical devices, the regulation of medical device software and mobile medical apps that are medical devices is risk-based. This means that the level of scrutiny and oversight by the TGA applied to a product will vary according to the level of risk that the product represents to the patient or healthcare professional using it. The potential risks arising from medical devices can be minor, or very significant indeed, depending on the nature of the device and its intended purpose.

PulseLine will be taking a keen interest in this project as it evolves. If you want to get involved contact the team using the link below, before close of business on the 20th of August 2018.

CSIRO project team member Dr Jill Freyne.[/vc_column_text][/vc_column][/vc_row]