Category: Patients
AUSTRALIANS LACK AWARENESS OF A SERIOUS HEALTH CONDITION
[vc_row][vc_column][vc_column_text]The reality is that more than 43,500 Australians die from cardiovascular disease with a further 41,400 deaths associated from it.[1] Heart disease remains the most expensive disease with more hospitalisations than any other disease, costing over $12 billion per year and estimated to increase to over $22 billion by 2032-33.[2]
What if I told you there is a disease that impacts 1 in 8 Australians over 75 and, of those, 1 in 3 are under-recognised and under-treated? The real kicker is that up to 50% of those Australians with the severe form of this disease will die within 2 years[3] unless they get surgery.
It’s a condition that’s as common as breast cancer.
Aortic stenosis is the narrowing of the aortic valve that restricts blood flow and, too often, the symptoms, such as chest pain, fainting upon exertion, shortness of breath and reduced activity, are dismissed as “getting old”.
With an ageing population, we will all need to look at ageing through a different lens. For example, Australians aged 65 years and over contribute almost $39 billion each year in unpaid caring and voluntary work. If the unpaid contribution of those aged 55 to 64 years is included, that figure rises to $74.5 billion per year.[4]
A YouGov study commissioned by Edwards Lifesciences surveyed 2004 Australians over the age of 60 and showed 79% of respondents don’t know what aortic stenosis is, despite it being the one of the most common and serious heart valve disease problems in developed countries. [5] The questions were based on a similar survey of 12,820 people aged 60 years or older in 11 European countries in 2017.[6]
Next year, 5.5 million Australians will be over the age 60 years, and this will increase to 6.9 million by 2030.[7] Of those, we estimate the prevalence of severe aortic stenosis will increase from ~35K to ~46K that’s a 31% increase in 10 years.
At present, we are only treating ~8036 Australians, leaving tens of thousands untreated and under-diagnosed.
A recent report[1] from Australian researchers found high rates of mortality associated with both moderate and severe aortic stenosis during long-term follow-up. As such, previous suggestions that moderate aortic stenosis is a benign condition are wrong.
In November, Medicare raised the rebate for heart health checks to 100%, meaning more than 1.5 million Australians at risk of heart attack or stroke now have access to GP-administered heart health checks.
We hope that checking for that ‘whooshing’ or ‘swishing’ sounds, which are signs of a heart murmur, is front of mind, because it will play a critical role in getting Australians at risk of cardiovascular disease the treatment they need.
At Edwards Lifesciences, we’re proud to be the market leader in patient-focused innovations for addressing structural heart disease. We’re committed to delivering innovative therapies for patients, whether it be for the aortic, pulmonary, mitral or tricuspid valves.
Heart disease is the number one cause of death in Australia. Should you be asking your doctor for a heart health check today?
For more information on aortic stenosis please visit: http://www.HopeforHearts.com.au or https://newheartvalve.com/au/[/vc_column_text][vc_zigzag][vc_row_inner][vc_column_inner width=”1/4″][vc_single_image image=”4394″ img_size=”full”][/vc_column_inner][vc_column_inner width=”3/4″][vc_column_text]
ABOUT THE AUTHOR
Pat Williams is the Managing Director of Edwards Lifesciences ANZ.
For more about Pat, watch: Pat Williams, talks about his journey into the MedTech and healthcare space.[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row][vc_column][vc_separator][vc_column_text][1] https://www.aihw.gov.au/reports/heart-stroke-vascular-disease/cardiovascular-health-compendium/contents/deaths-from-cardiovascular-disease
[2] https://www.baker.edu.au/-/media/documents/impact/baker-institute_no-second-chances.pdf
[3] Otto CM. Timing of aortic valve surgery. Heart. 2000;84:211-8.
[4] https://aifs.gov.au/publications/archived/1044
[5] Osnabrugge MS et al ‘Aortic Stenosis in the Elderly. Disease Prevalence and Number of Candidates for Transcatheter Aortic Valve Replacement: A Meta-Analysis and Modelling Study’ JACC 2013 Vol. 62, No 11, 2013
[6] https://link.springer.com/article/10.1007%2Fs00392-018-1312-5
[7] https://www.abs.gov.au/AUSSTATS/abs@.nsf/DetailsPage/3222.02017%20(base)%20-%202066?OpenDocument
[8] https://doi.org/10.1016/j.jacc.2019.08.004[/vc_column_text][/vc_column][/vc_row]
HOW WELL MAINTAINED IS MEDICAL EQUIPMENT IN HOSPITALS?
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NSW Auditor-General’s Report: Performance Audit – Medical equipment management in NSW public hospitals, May 2017
The NSW Auditor General found that: “Only about half the items of equipment included in our sample had testing and maintenance completed according to scheduled intervals or within 30 days of the scheduled date. These intervals were set under the Australian/ New Zealand Standard 3551 ‘Management programs for medical equipment’, which requires regular testing and maintenance of biomedical equipment to ensure it is safe and suitable for clinical use.”
While AS/NZS 3551 may have stipulated a 30-day time frame for completing maintenance within the scheduled date in its previous 2004 version, it no longer specifies any time frame for completing maintenance in its current 2012 version. Instead it states in section 6.7.2 When assessment and testing are delayed: “Where medical equipment is identified as beyond its anticipated re-assessment date, the responsible organization [i.e., hospital] shall be advised that service and testing are overdue. The medical equipment shall be made available at a mutually acceptable time to the clinical user and the service entity to allow assessment of the medical equipment to bring it into compliance.”
An open-ended “mutually acceptable time” for the hospital and the service entity may not be acceptable to ensure the safety of patients. Since the standard does not require that the decision to delay be appropriately approved and documented (justification, approver with management responsibility), it is likely that nobody will feel accountable for maintenance delays.
The audit report also found that: “The information systems used to record service histories of biomedical equipment were inefficient and inadequate for effective planning, monitoring and reporting of testing and maintenance. The implementation of a state-wide asset management system, Asset and Facilities Management Online (AFM Online), which will replace existing systems, has experienced delays. In addition, hospitals did not maintain adequate oversight of testing and maintenance that was outsourced to external contractors.”
Inefficient and inadequate information systems for medical equipment management coupled with slack requirements in AS/NZS 3551:2012 are a very bad combination indeed, likely to result in poor maintenance practices and adverse events.
It is not clear why the 30-day time frame for completing maintenance within the scheduled date was removed from AS/NZS 3551:2012. This change is not even listed in the PREFACE on page 2 of the standard along with other “principal differences”; is it really such a negligible change?
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Victorian Auditor-General’s Report: Efficiency and Effectiveness of Hospital Services – High-value equipment, February 2015
The audit of the Victorian Auditor General’s examined the effectiveness and efficiency of planning, delivery and utilisation of high-value imaging equipment in Victorian public hospitals such as CT and MR, and found that public CT and MR imaging services “are not being managed economically, efficiently or effectively across Victoria”.
The report concludes that: “Poor medical equipment asset management practices in public health services exacerbate a lack of planning at the health-system level. None of the six public health services visited had an asset management plan that included imaging equipment. The health services could not communicate to the department—or clearly identify—what their future imaging needs would be over the medium to longer term. This means that although future demand is set to increase, it is not clear at either the health-system or health-service level how that demand might best be met.”
The Auditor General’s report does not mention the AS/NZS 3551 standard at all, but the Victorian Department of Health refers to AS/NZS 3551:2004 in its Medical equipment asset management framework – Parts A and B of 2014 and Part C of 2012. Section 4.2 Maximise the effective life of the asset states: “The maintenance requirements of specific items are determined by the original equipment manufacturer guidelines (as described in the service or maintenance manual) and Australian and New Zealand Standard (AS/NZS) 3551 — Technical management programs for medical devices.”
It is not clear whether the maintenance and management programs for medical equipment have been audited by the Victorian Auditor General at all.
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Western Australian Auditor General’s Report: Management of Medical Equipment, May 2017
This audit assessed whether the management of medical equipment in public hospitals is efficient and effective. The audit report points out that: “Medical equipment can be technically complex and require specialist expertise to use, maintain and repair. It generally has an expected life of between 5 and 10 years depending on the type of equipment. The actual life will also depend on a wide range of factors including how often it is used, how reliable it is and how well it is maintained. The unavailability or failure of equipment can present significant risks to patients, staff and service delivery – risks that the health system needs to manage. Individual health service providers and hospitals are responsible for managing their own equipment, including planning, acquisition, maintenance, repair and disposal.”
The audit report concludes: “Equipment failure or unavailability due to repair or maintenance rarely has a serious impact on patient care. However, it does cause incidents and inefficiencies. The risk of adverse events was also increased because preventative maintenance for 16% of equipment we sighted was not done on time, and yet the un-serviced equipment remained available for use. Keeping to maintenance schedules is even more important as 36% of equipment we sighted across our 8 sample hospitals had exceeded its expected life.”
The AS/NZS 3551 is not mentioned in the audit report at all, however the Western Australian Department of Health’s policy for the management of medical equipment of 2019 quotes AS/NZS 3551:2012 as the underlying basis for compliance.
The current approach of State health policies in relation to medical equipment management and maintenance practices appears to be particularly inward looking, with little or no acknowledgement of international best practices like those described in the:
- international standard ISO 55001:2014 Asset management – Management systems;
- international standard IEC 62353:2014 Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment;
- WHO Health technology management resources, encompassing a series of guides published since 2011 (see Figure), including:
- Procurement process resource guide
- Medical equipment maintenance programme overview
- Computerized maintenance management system
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People living with diabetes now have broader access to blood glucose monitoring products in Australia
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Diabetes is considered an epidemic in Australia, with 1.7 million Australians living with the condition and a further 280 people diagnosed each day.
“While pharmacy remains the key access point for products that are reimbursed via the National Diabetes Services Scheme (NDSS) and to seek advice, it is evident that many Australians are simply not managing their diabetes effectively and we want to ensure that access is not a barrier,” said Ms Jane Crowe, General Manager, Roche Diabetes Care Australia.
“We are committed to innovation, not only in our product development, but also in ways in which consumers can access them. Given this range is not reimbursed via the NDSS, no form is required to purchase the products, enabling us to establish the partnership with Woolworths and broaden availability.
“As the market leader in diabetes monitoring, we are passionate about understanding the needs of people with diabetes and offering them broad access to encourage regular self-management,” said Ms Crowe.
Roche Diabetes Care has been pioneering innovative diabetes technologies and services for more than 40 years. Being a global leader in integrated personalised diabetes management, we work every day to support people with diabetes and those at risk to achieve more time in their target range and experience true relief from the daily therapy routines.
Under the brand Accu-Chek and in collaboration with partners, Roche Diabetes Care creates value by providing integrated solutions to enable optimal personalised diabetes management.
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Impact of MedTech – Anthony’s Story
[vc_row][vc_column][vc_column_text]Aortic Stenosis (AS), a narrowing of the aortic valve that restricts blood flow, is the one of the most common and serious heart valve disease problems in developed countries. It is an under-recognised phenomenon and a challenging condition to diagnose as it can be silent for a long period of time.
Historically rheumatic disease and congenital conditions were common causes of AS, however with increased longevity, the most common cause of AS today is degenerative calcification of the aortic valve. This causes subtle symptoms such as shortness of breath and the reduced ability for normal activities which many patients and clinicians dismiss as part of the normal aging process or being “out of shape”.
This month HeartKids, the only national charity dedicated to supporting children, teens and adults affected by congenital heart disease all across Australia celebrates Show Your Heart for Little Hearts. Edwards Lifesciences Foundation is a proud supporter of HeartKids. Congenital heart disease is the most common congenital disorder in newborns. The birth rate prevalence of congenital heart disease is understood to be approximately 8 – 10 cases per 1,000 live births.[/vc_column_text][/vc_column][/vc_row]
Reference Pricing – Does It Add Up?
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- Why does it matter? The private health insurance (PHI) industry has been actively lobbying the government to cut the costs of premiums, which has resulted in benefits and choice being slashed for hard working Australian families. A tactic of the PHI industry is to try to focus as much blame, for the high premiums they charge, onto others, including medical technology innovators.
- What is their argument? The PHI industry believes the cost of medical devices, as well as keeping vulnerable people who are suffering from a mental health condition in hospital too long, is causing premiums to rise. The PHI industry also wants the government to implement ‘international reference pricing’ to further cut into the prices of medical devices in Australia.
This is where the ‘apple and oranges’ comparison comes into play. Let’s explain: Like any product or service, the price for medical devices can vary from one country to another. Just as the price of a Toyota Sedan in Texas might be different from the price of a Toyota Sedan in Sydney or Adelaide.
- What causes the difference in price? The price difference can be attributed to several factors, including:
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- Differences in healthcare systems;
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- Differences in purchasing arrangements and market segmentation;
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- Differences in price/benefit determination;
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- Differences in volumes of devices being used;
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- Differences in the level of technical manufacturer support needed;
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- Geographical differences; and
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- Economic difference.
Now despite all these difference that can affect price, the total PHI spend on medical devices is just 10%. Thanks to, what is called, the Prostheses List (PL), Australians can access innovative and leading medical devices, giving them certainty of access and cost (currently nil) to a wide range of prostheses.
KEY INSIGHTS: Comparisons across different markets will result in PL benefit adjustments that could reduce patients’ access to devices recommended by their physicians and force patients to pay more for the same products.
- The Productivity Commission released a report in 2001 relating to international price comparisons of pharmaceuticals which said: “It’s difficult to identify robust specific explanations for the observed bilateral price differences. Rather, the price differences are probably due to a combination of influences, including systemic differences in health systems…”
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Final prostheses price cuts: most common hip replacement 29.5% cheaper
[vc_row][vc_column][vc_column_text]February 1, 2020 marked the final price reduction for devices on the Prostheses List as per an agreement (the Agreement) between the Medical Technology Association of Australia (MTAA) and the Minister for Health, Greg Hunt MP, entered into on October 2017.
Price cuts under the Agreement have already saved insurers a total of A$390 million and the savings are on track to exceed the A$1.1 billion in total expected by 2022. Between the Agreement and the 7.5% benefit reduction for hip prostheses announced by then-Minister for Health Sussan Ley in October 2016, the medical devices sector has undergone four significant price cuts.
“Every day we at Stryker are driven by our mission to make healthcare better for patients, that includes ensuring Australians have access to affordable, high quality medical technology” said Maurice Ben-Mayor, President of Stryker South Pacific.
“We believe that the Prostheses List is an effective, transparent mechanism to protect patients from out-of-pocket costs and guarantee choice of the most clinically effective prostheses for their individual needs.
“The MTAA’s Prostheses List Agreement was modelled on the assumption that private health insurers would pass the A$1.1 billion of savings from medical device price cuts onto their members in the form of lower private health insurance premiums.
“Unfortunately, I have seen little evidence that these savings have been passed on in full to consumers.”[/vc_column_text][/vc_column][/vc_row]
What is a super spreader? An infectious disease expert explains
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What is a super spreader?
Researchers currently estimate that a person carrying the Wuhan coronavirus will, on average, infect approximately 2.6 people.
Recent reports out of Wuhan also cite a case of a single patient who infected 14 health care workers. That qualifies him as a super spreader: someone who is responsible for infecting an especially large number of other people.
During an emerging outbreak, epidemiologists want to determine whether super spreaders are part of the picture. Their existence can accelerate the rate of new infections or substantially expand the geographic distribution of the disease.
In response to super spreaders, officials can recommend various ways to limit their impact and slow the spread of disease, depending on how the pathogen is transmitted. Pathogens transmitted via air droplets, contaminated surfaces, sexual contact, needles, food or drinking water will require different interventions. For example, the recommendation for face masks would be specific to airborne transmission, while hand-washing and surface sterilization are needed for germs that can live for a while on surfaces.
What are the characteristics of a super spreader?
Whether someone is a super spreader or not will depend on some combination of the pathogen and the patient’s biology and their environment or behavior at the given time. And in a society with so much global connectivity, the ability to move pathogens rapidly across great distances, often before people are even aware they are sick, helps create environments ripe for super spreading.
Some infected individuals might shed more virus into the environment than others because of how their immune system works. Highly tolerant people do not feel sick and so may continue about their daily routines, inadvertently infecting more people. Alternatively, people with weaker immune systems that allow very high amounts of virus replication may be very good at transmitting even if they reduce their contacts with others. Individuals who have more symptoms – for example, coughing or sneezing more – can also be better at spreading the virus to new human hosts.
A person’s behaviors, travel patterns and degree of contact with others can also contribute to super spreading. An infected shopkeeper might come in contact with a large number of people and goods each day. An international business traveler may crisscross the globe in a short period of time. A sick health care worker might come in contact with large numbers of people who are especially susceptible, given the presence of other underlying illnesses.
When have super spreaders played a key role in an outbreak?
There are a number of historical examples of super spreaders. The most famous is Typhoid Mary, who in the early 20th century purportedly infected 51 people with typhoid through the food she prepared as a cook. Since Mary was an asymptomatic carrier of the bacteria, she didn’t feel sick, and so was not motivated to use good hand-washing practices.
During the last two decades, super spreaders have started a number of measles outbreaks in the United States. Sick, unvaccinated individuals visited densely crowded places like schools, hospitals, airplanes and theme parks where they infected many others.
Super spreaders have also played a key role in the outbreaks of other coronaviruses, including SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome). A traveler sick with SARS and staying in a Hong Kong hotel infected a number of overseas guests who then returned home and introduced the virus into four other countries.
For both SARS and MERS, super spreading commonly occurred in hospitals, with scores of people being infected at a time. In South Korea in 2015, one MERS patient infected over 80 other patients, medical personnel and visitors in a crowded emergency department over a three-day period. In this case, proximity to the original patient was the biggest risk factor for getting sick.
Can super spreading occur in all infectious diseases?
Yes. Some scientists estimate that in any given outbreak, 20% of the population is usually responsible for causing over 80% of all cases of the disease. Researchers have identified super spreaders in outbreaks of diseases from those caused by bacteria, such as tuberculosis, as well as those caused by viruses, including measles, MERS and Ebola.
The good news is that with the right control practices specific to how pathogens are transmitted – hand-washing, masks, quarantine, vaccination and so on – the transmission rate can be slowed and epidemics halted.[/vc_column_text][vc_zigzag][vc_column_text]
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This article originally appeared on theconversation.com.
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POOR QUALITY REPAIRS OF AND MODIFICATIONS TO MEDICAL EQUIPMENT PUTTING PATIENTS AT RISK
[vc_row][vc_column][vc_column_text]Playing cards are fine for playing poker, not for gambling with a patient’s safety. The picture in Figure 1 shows a “repaired” endoscope by a hospital contractor hired to repair medical equipment. The playing card was used to separate the angulation wires from the image and light guide bundles to protect them from the open solder joints. No heat shrink was used to provide environment sealing protection. This is a serious material incompatibility issue. The paper of the playing card is flammable and its use on open solder joints can lead to fire and serious patient injury.
Although medical devices are regulated by the Therapeutic Goods Administration (TGA), the TGA does not have jurisdiction over hospitals. A lack of regulatory oversight has resulted in a proliferation of businesses selling repairs of medical equipment and maintenance-related services to hospitals. Most if not all of these businesses have no links to the original manufacturer. Therefore, it is anyone’s guess how hospitals ensure that medical equipment under their care remains safe and works as per the manufacturer’s original specifications, and who checks whether these contractors and consultants have the minimum level of competence and training to perform repairs and maintenance on medical equipment.
If a patient is injured by a poorly repaired medical equipment or by a medical device rendered unsafe by modifications, the hospital has no obligation to report the adverse event to the TGA. The poor level of incident reporting by hospitals is reflected in the TGA statistics (shown in Figure 2). According to the current law, only manufacturers and sponsors of medical devices have an obligation to report incidents and adverse events to the TGA. It is safe to assume then that, unless a hospital informs the manufacturer or sponsor, incidents involving medical equipment repaired and maintained by the hospital or on behalf of the hospital will go unreported.[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_single_image image=”4286″ img_size=”full” add_caption=”yes”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]Even if the original manufacturer is informed of adverse events involving repaired/ serviced medical equipment, the hospital has no obligation to provide TGA or anyone else with information and records related to repairs and modifications undertaken by the hospital or on behalf of the hospital.
Patient and consumer groups such as CHOICE or Consumer Health Forum (CHF) have a right and indeed an obligation to understand what is happening in relation to post-market repairs and modifications of medical devices. The Australian Commission for Safety and Quality in Health Care (ACSQHC) has issued a number of National Safety and Quality Health Service (NSQHS) standards. Unfortunately, none of the NSQHS standards cover repair and maintenance of medical equipment in hospitals. The only standardisation of repair and maintenance of medical equipment in healthcare facilities is left to Standards Australia HE-003 committee, however neither the ACQHC, nor the CHF are represented in HE-003.
Playing cards have no place in healthcare.[/vc_column_text][/vc_column][/vc_row]
New research to tackle Australia’s two biggest killers
[vc_row][vc_column][vc_column_text]The Government’s investment will support innovative, high quality, collaborative research that focuses on prevention, early-intervention, treatment and survivorship of heart disease and stroke.
This round will focus on three priorities:
- Preventing heart disease and stroke.
- Improving survival rates after an acute heart or stroke event.
- Improving survival after a cardiovascular event or stroke and preventing a recurrence.
In 2018, ischaemic heart disease killed 17,533 Australians and cerebrovascular diseases (stroke) killed 9,972 Australians.
However, cardiovascular disease is an area in which Australia can boast strong recent successes, with deaths falling by almost 70 per cent over the past three decades.
Much of this success has been achieved through improvements in the prevention, detection and management of the disease.
The Government has committed to a strong research agenda to find more effective methods for preventing, treating and managing heart conditions and, ideally, a cure.
More than $1.7 billion has been invested in clinical research into cardiovascular disease through National Health and Medical Research Council grants since 2000.
The Government is now investing $220 million from the $20 billion Medical Research Future Fund (MRFF) for the dedicated 10-year Cardiovascular Health Mission.
The Mission aims to improve health outcomes through prevention strategies and earlier detection for patients suffering a heart attack or stroke.
It will support Australian researchers to make game-changing discoveries, develop a global biotech industry and enable the implementation of changes in health care.
Grants open on 13 December 2019 and will be managed by the National Health and Medical Research Council. For more information on how to apply, visit GrantConnect.[/vc_column_text][/vc_column][/vc_row]
