Author: Team

Digital transformation to deliver more timely medicines for Australians and improve patient safety

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[vc_row][vc_column][vc_column_text]The Government is investing $12 million over four years to digitise, transform and modernise the TGA’s business systems and infrastructure, better connecting services to get medicines and devices to patients sooner.

New digital processes will deliver simpler and faster interactions between industry and government. This means earlier approvals of medical products, reduced administrative effort, and timelier decision-making by the TGA.

Under this Deregulation Agenda, the Government has said focused on ensuring regulation is and remains fit-for-purpose – making it easier to do business while ensuring essential safeguards with the lightest touch.

This measure will yield a significant reduction in red tape, cutting costs for the medicines and medical devices industry. It will also position Australia to more quickly access emerging and new health technologies in the international market.

The TGA receives around 26,000 applications every year for medicines and medical devices to be listed or amended on the Australian Register of Therapeutic Goods (ARTG), which allows them to be imported, sold and used in Australia.

The digital changes will enable simpler and more secure interactions between Government and industry to apply for, track, pay, and manage listings for regulated and subsidised health related products and services.

The TGA receives 15,000 adverse drug reaction reports on patient safety per year which are entered manually through PDF rather than through a central database.

With these reforms, medical companies will now be able to use an electronic database to report these patients safety events with automatic data transfer – saving them up to 15 minutes per report.

All Australians will benefit from a streamlined process which increases the timeliness of decisions on the safety, quality and efficacy of therapeutic goods, and their approval for listing on the ARTG.

Consumers and health care professionals can also have greater confidence in the safety and efficacy of therapeutic goods, with increased transparency built into the reforms.”

Cyber security will also be bolstered to ensure the protection of commercial-in-confidence information from industry.[/vc_column_text][/vc_column][/vc_row]

AHHA CALLS FOR BETTER COVID-19 DOCUMENTING

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[vc_row][vc_column][vc_column_text]The COVID Screen Audit study has been published in Australian Health Review, the journal of the Australian Healthcare and Hospitals Associations (AHHA).

Research team leader and professor at the University of Melbourne, David Story, said the study analysed the admission records of 2,197 patients who underwent elective and non-elective surgery at two major Melbourne hospitals between 1 April and 10 May 2020.

“Despite the national imperative to screen for COVID and communicate the results, the documenting of COVID-19 screening fell short of our proposed lower acceptable limited on 85% in almost all surgical groups,” Professor Story said.

“We are not saying screening wasn’t done – that that the information wasn’t readily available for clinical teams caring for some patients.

“The percentages of surgery patients observed to have had both COVID-19 screening and temperature documented could be improved, from 72% among elective patients and 38% among non-elective patients.”

The study found that documenting screening varied markedly across surgical groups. In particular, it found that non-elective surgical patients had the lowest rate of documenting and also the highest rate of COVID-19 related history and signs.

Identifying surgical patients with SARS-CoV-2 and COVID-19 disease is important for several reasons, including that patients with COVID-19 may have more complications and greater mortality after surgery. COVID-19 may also further increase the already increased risk for complications and mortality among non-elective patients.

Professor Story added that the results of the COVID Screen Audit were likely to apply to other Australian hospitals, and noted both hospital had instituted far more rigorous documenting during Victoria’s second wave of the pandemic.[/vc_column_text][/vc_column][/vc_row]

COVAX commitment a big step forward

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[vc_row][vc_column][vc_column_text]Australia has confirmed it will participate in the COVAX purchasing mechanism, which involves the World Health Organisation, the vaccine alliance Gavi, and the Coalition for Epidemic Preparedness Innovations.

COVAX pools the resources of wealthier and poorer nations to create global demand for two billion vaccines, accelerating the development and distribution of a successful COVID vaccine or vaccines.

Australia’s participation means Australia and poorer nations in our region are far likelier to have early access to a vaccine, said Reverend Tim Costello.

“This announcement helps secure vaccines for Australian citizens, and people in vulnerable nations who have no hope of producing or purchasing vaccines on their own,” Reverend Costello said. “It is an important development and the Australian Government should be commended for meeting its moral obligation to help others also defeat this virus.

“COVID-19 does not respect borders or political systems. It rips through societies like wildfire, wrecking industries and livelihoods. No community is immune and it is in everyone’s interest to suppress this virus as effectively as we can possibly can.

“Australia’s participation in the COVAX effort is incredibly worthwhile. This could be bolstered by additional aid efforts. We know the pandemic is creating serious roadblocks to combating existing epidemics such as HIV, tuberculosis and malaria. COVID is impeding the economic empowerment of women and girls as resources are stretched to deal with the pandemic.

“The Australian Government should build on this announcement with further support for the heath and economic development aspirations of poorer nations. It is profoundly in Australia’s interests to foster a healthier, more prosperous environment in its region and beyond.”

Indonesia has now recorded more than 9,000 COVID-10 related deaths, and in recent weeks the average number of new cases has risen from about 2,000 per day to more than 3,500.

In the Pacific the economic impact of COVID-19 could result in an additional 1.2 million people in the Pacific and Timor-Leste being pushed into extreme poverty.

Globally already in 2020, the pandemic has pushed almost 37 million people below the[/vc_column_text][/vc_column][/vc_row]

Nominations Open for 2020 Kerrin Rennie Award

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[vc_row][vc_column][vc_column_text]MTAA and the #MedTech community would like to recognise that technology at the upcoming Australian MedTech Industry Awards.

If you know of an innovative product launched in Australia within the last two years used in the diagnosis, prevention, treatment or management of disease and disability, we encourage you to nominate that technology for the 2020 Kerrie Rennie Award.

Other award categories are available on the MTAA website.[/vc_column_text][vc_zigzag][vc_btn title=”SUBMIT NOMINATION” color=”turquoise” align=”center” link=”url:https%3A%2F%2Fwww.mtaa.org.au%2Faustralian-medtech-industry-awards|||”][/vc_column][/vc_row]

MedTech20 Presenter Spotlight – Prof. Wendy Rogers

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[vc_row][vc_column][vc_column_text]Wendy is co-chair of the Safety, Quality and Ethics Program of the Australian Alliance for AI in Healthcare. Wendy has a longstanding interest in the ethics and regulation of innovative technologies.

Her current projects include ethical issues raised by AI in healthcare, the ethics of surgical research and innovation, the ethics of synthetic biology, and transplant abuse in China. Wendy has served two terms on the Australian Health Ethics Committee and has had longstanding involvement in the drafting and revision of the current and previous versions of the National Statement on Ethical Conduct in Human Research.

She was named in 2019 by Nature as one of ten people who matter in science for her work exposing publication of unethical transplant research, and was the Australian 2019 national research field leader in bioethics.[/vc_column_text][/vc_column][/vc_row]

$12.5m enables new research approach to Parkinson’s

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[vc_row][vc_column][vc_column_text]“The outcomes of this research promise to provide new insights into the genetics of what determines the development and progression of Parkinson’s disease, “said Professor Deniz Kirik, Faculty of Medicine, Lund University who will be the lead investigator on the research project for the University of Sydney as an Honorary Professor for the duration of the research.

ASAP seeks to support international, multidisciplinary, multi-institutional research teams to address key knowledge gaps in the basic disease mechanisms that contribute to Parkinson’s. The initiative is focused on understanding the dynamics of Parkinson’s from its earliest stages and before it presents as a fully-recognisable condition.

The research being funded is focused on how mutations and/or deletions in specific genes result in a high probability of developing Parkinson’s disease (PD), suggesting their critical role in the health and survival of specific brain cells.

“Curiously, it is not yet clear how specific types of brain cells are functionally impacted by genetic mutations that result in the neuronal loss defining Parkinson’s. The research supported by this grant will address that,” said Professor Kirik.

Previously, affected cells have mainly been examined as cultured cells in petri dishes but this project will focus on using cells from patients with Parkinson’s to study them in the environment of the living mouse brain. This is a completely new way of exploring the cellular components and underlying biology of the disease. The researchers will then explore how gene editing could address the underlying basis of the disease.

“This generous grant allows Professor Kirik to build new research capabilities in neuronal transplantation at the University of Sydney, and collaborate on genomics and human neural stem cells with myself and Professor Carolyn Sue from the Kolling Institute,” said Professor

Glenda Halliday, one of the lead researchers from the University of Sydney’s Faculty of Medicine and Health and member of the University’s Brain and Mind Centre.

“It will also build on Professor Kirik’s strong collaborations with Professor Claire Parish and Associate Professor Lachlan Thompson at the Florey Institute in Melbourne, and Jennifer Johnson at NysnBio in California.”

Professor Sue, Executive Director, Professor and Director of Neurogenetics, Kolling Institute, University of Sydney said: “We have world- leading expertise in this field and have been selected to take part after a worldwide search for innovative programs to speed up the search for new treatments for Parkinson’s disease. The program illustrates the importance of our translational research at the Kolling Institute, where we can directly incorporate scientific breakthroughs to improve clinical care for our patients.”

The research team members are:

 Project lead: Professor Deniz Kirik, Faculty of Medicine Lund University, Sweden, has over 25 years’ experience in the development of cell and gene therapy for treatment of neurodegenerative diseases, with special emphasis on Parkinson’s disease. He has made significant contributions to cell therapy for PD which have been instrumental in taking novel treatments into clinical testing. (Professor Kirik and his team will eventually be based at the University of Sydney for the duration of the research, once COVID conditions permit).

Core leadership and Collaborators:

  Professor Glenda Halliday,NHMRC Senior Leadership Fellow, Faculty of Medicine and Health and Brain and Mind Centre, University of Sydney. Expertise in the development of neurodegenerative disorders including Parkinson’s disease and the role of Lewy bodies (clumps of proteins that form in the brain). Her current work focuses on how proteins identified through genetic studies are involved in neurodegeneration.

Professor Carolyn Sue, Executive Director, Professor and Director of Neurogenetics, Kolling Institute, University of Sydney and Director of Neurogenetics at Royal North Shore Hospital, University of Sydney. A clinician-scientist, whose research team combines the use of genomics, molecular neuroscience, and adult stem cell models to identify pathogenic mechanisms and develop targeted therapies for Parkinson’s disease and other related neurodegenerative disorders.

Professor Clare Parish, The Florey Institute of Neuroscience and Mental Health, Victoria is a developmental neuroscientist with 20 years of experience in Parkinson’s disease research. Expertise includes using advanced stem cell-based therapies for neural repair in Parkinson’s disease. She has an international reputation in improving the safety and functional integration of stem cell-derived neural transplants for Parkinson’s disease.

Associate Professor Lachlan Thompson, The Florey Institute of Neuroscience and Mental Health is a neurobiologist specialising in neural transplantation both as a therapeutic approach for brain and spinal cord repair, and as a way to understand the properties of neurons generated from human stem cells. He is the inaugural co-chair of the Asia-Pacific Association for Neural Transplantation and Repair.

Jennifer Johnston, CEO NysnoBio, California, has been studying neurodegenerative disease for the last 20 years. NysnoBio is a biotech company focused on the modulation of the parkin enzyme pathway for critical unmet medical needs in neurology and oncology (Parkin plays an essential role in maintenance of brain cells that create dopamine, which degenerate in Parkinson’s disease).[/vc_column_text][/vc_column][/vc_row]

Colin McFarlane’s Story – Life with a Heart Valve Implant Since 1973

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[vc_row][vc_column][vc_column_text]After waiting six months for the valve to arrive from the United States, Colin was operated on at RPA by pioneering heart surgeon Bruce Leckie, and told he would need the valve replaced in 10 to 15 years.

“But once we got to 15 years, everybody threw their hands up in the air and said ‘pick a number, we don’t know’,” Colin says.

“So, here we are in the 47th year. It seems like it’s indestructible.”

But it almost never happened.

In 1958, retired engineer Miles Lowell Edwards, who had suffered rheumatic fever himself as a child, had set out to build the world’s first artificial heart.

Edwards presented the concept to Dr Albert Starr, a young surgeon at the University of Oregon Medical School.

Starr thought the idea was too complex and encouraged Edwards to focus on developing an artificial heart valve instead.

Within weeks, Edwards was sending Starr prototypes built in his home workshop.
And then in September, 1960, they had incredible success when the caged ball design was implanted in a 52-year-old man who underwent a “spectacular recovery and return to normal life”.
Last month, Colin and his daughter, Cheryl, visited Edwards Lifesciences in Macquarie Park tell his story – and thank the people who saved his life.

“We were told dad had a life expectancy of mid 50s,” says Cheryl.

“He’ll be 83 in February. You’ve given us a dad for a lifetime. But you’ve also given us a dad who hasn’t been sickly; a dad who has enjoyed life; who came to sports with us; who could take us on holiday.”[/vc_column_text][/vc_column][/vc_row]

MedTech20 – Tracey Duffy announced at MedTech20 Virtual Conference

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[vc_row][vc_column][vc_column_text]The Health Products Regulation Group comprises the Therapeutic Goods Administration and the Office of Drug Control. Her current responsibilities include medical device regulation, Good Manufacturing Practice medicine inspections and Laboratory testing. Tracey has held several leadership roles within the Department of Health and private sector experience including consultant health related advisory roles.[/vc_column_text][/vc_column][/vc_row]

MEDTRONIC STUDY FINDS OPIOID-INDUCED RESPIRATORY DEPRESSION IN THE HOSPITAL MORE COMMON AND COSTLY

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Importantly, conclusions from the study data enabled the development of the PRODIGY Risk Score, an easy-to-use risk prediction tool to identify patients at high risk of respiratory depression who would benefit from continuous monitoring with capnography and pulse oximetry.

The study, which analyzed 1,335 patients across 16 sites in the United States, Europe and Asia, found that respiratory depression, as defined by changes in pulse oximetry and capnography monitoring parameters, occurred in 46% of medical and surgical patients evaluated who were receiving IV opioids for pain. This incidence rate is significantly higher than previously reported in clinical literature.1 The complete study results are published online in Anesthesia and Analgesia1, the official journal of the International Anesthesia Research Society (IARS).

“PRODIGY data confirms that respiratory depression in patients receiving parenteral opioids occur frequently and are potentially unknown to hospital healthcare providers,” said Ashish K. Khanna, M.D., primary study investigator and an associate professor of Anesthesiology, section head for Research and intensivist at the Wake Forest School of Medicine. “Together with risk assessment using the PRODIGY Risk Score, the use of capnography and oximetry for continuous monitoring of patients identified as high risk for respiratory depression may increase safety when parenteral opioid analgesia cannot be avoided.”

Currently, there are no universally accepted guidelines to direct effective and safe assessment and monitoring practices for patients receiving in-hospital opioid analgesia. In addition to providing insight into the rate of respiratory depression, a key objective of PRODIGY was to develop and validate an accurate and easy-to-use risk assessment scoring tool. The PRODIGY Risk Score uses risk factors including: age > 60 years, male gender, opioid naïvety, sleep disorders and chronic heart disease for respiratory depression events risk prediction.

“The PRODIGY Risk Score has acceptable accuracy for risk stratification using several robust methods of internal validation, addressing significant gaps in preventing this common and potentially deadly condition,” said Frank Chan, vice president and general manager of the Patient Monitoring business, which is part of the Minimally Invasive Therapies Group at Medtronic. “Patients with respiratory depression were more likely to experience an adverse event that prolonged hospitalization and more likely to require rescue action, including rapid response team activation.”

The PRODIGY study is the largest known study using continuous capnography and pulse oximetry data on surgical and medical patients collected by Medtronic Microstream and

Nellcor monitoring technology. The study design used an innovative mechanism of data collection whereby bedside providers were blinded to continuous monitoring systems and all alarms were also silenced. All patients experiencing respiratory depression were reviewed and confirmed by an independent clinical event committee of physicians with expertise in perioperative respiratory medicine.

 

About Respiratory Compromise

Respiratory compromise is a potentially life-threatening, progressive condition negatively impacting a person’s ability to breathe adequately to maintain oxygenation and carbon dioxide removal. Patients with respiratory depression may experience shallow, slow or no breathing after opioid administration which undetected can lead to cardiopulmonary arrest and death.3 This condition is rapidly becoming the third-most costly hospital inpatient expense in the U.S., and dramatically increases the likelihood of adverse patient outcomes and cost of patient care.4 Not only is respiratory compromise common and dangerous, it has been very difficult to predict.[/vc_column_text][/vc_column][/vc_row]