Author: Team
Diversity and Inclusion @ Terumo Australia
[vc_row][vc_column][vc_column_text]In 2018, Terumo Australia launched a strategy on Diversity and Inclusion to ensure that everyone in the organisation recognises that all people bring different qualities, skills, knowledge, experiences, perspectives and attitudes to the workplace.
Through our proactive efforts and initiatives to promote Diversity and Inclusion throughout the business, we are now proud to have been recognised by Diversity Council Australia (DCA) for being an Inclusive Employer 2019-2020 and have been encouraged to utilise the above logo as part of our employer branding.
Our workforce was measured against the DCA – Member Leading Practice Benchmark and a National Index Benchmark (derived from a nationally representative survey of 3,000 Australian workers).
To be successful an organisation needed to exceed the National Index Benchmark on at least five out six of the following measures:
- Awareness;
- Engagement;
- Inclusive Organisational Climate;
- Inclusive Leadership;
- Inclusive Team; and/or
- Exclusion
Terumo Australia truly embodies its commitment to diversity and inclusion by welcoming a culturally diverse workforce with our associates representing over 20 ethnic backgrounds.
This enables us to expand knowledge and diversity of thought throughout the business, which in turn provides Terumo Australia with employees who bring forth new and better ways of doing this; and harness the benefits of worldly views and experiences to improve the quality of our services.
We are also proud to share that our gender balance in management roles is nearly 50:50 representation of males and females, in our workforce where 73% of associates are female!
Over the last 2 years, Terumo Australia has rolled-out a number of initiatives to blend diversity and inclusion in every day operations of our business including:
- Linking employees’ performance and development plans with company values that support respect, integrity, responsibility, teamwork and professionalism;
- Adhering to the Code of Conduct and policies around diversity, anti-discrimination and bullying;
- Introducing family friendly policies, such as flexible workplace practices and childcare assistance, which assist associates with maintaining their work/life balance and responsibilities while developing or maintaining a career;
- Ensuring fair and consistent approaches are in place around recruitment and development, including
- using inclusive language in our position descriptions
- training for everyone to raise awareness around unconscious biases
- training hiring managers to be mindful of biases and discrimination during recruitment
- ensuring any agencies, we work with are aware of our Diversity Policy, and encourage a diverse mix of candidates
- continue to expand our reach to a wider diverse market, with a focus on opportunities for people with disabilities
- Offering support systems and programs available through our Employee Assistance Program;
- Providing education sessions across the business through Lunch and Learns, webinars and e-learning modules; and
- Keeping up to date with diversity and inclusion initiatives around us through corporate memberships with external organisations such as Diversity Council Australia.
We continue to monitor our progress against the strategy set out in 2018 to ensure we maintain and deliver on our commitment to diversity and inclusion, to celebrate our differences, and to create a collaborative culture that drives innovation, customer service excellence and facilitates positive associate and customer experiences.[/vc_column_text][/vc_column][/vc_row]
Impact of MedTech – Colleen O’Neill-Mullins’ Story
MEDTRONIC SHARES VENTILATION DESIGN SPECIFICATIONS TO ACCELERATE EFFORTS TO INCREASE GLOBAL VENTILATOR PRODUCTION
[vc_row][vc_column][vc_column_text]Introduced in 2010, the PB 560 is sold in 35 countries around the world. This ventilator’s ability to be used in a range of care settings, as well as its technology and design, make it a solid ventilation solution for manufacturers, inventors, start-ups, and academic institutions seeking to quickly ramp up ventilator design and production. PB 560 product and service manuals, design requirement documents, manufacturing documents, and schematics are now available at Medtronic.com/openventilator. The PB 560 design specifications are available today, software code and other information will follow shortly.
The PB 560 ventilator is a compact, lightweight, and portable ventilator that provides airway support for both adults and children. It can be used in clinical settings and at home and provides mobile respiratory support.
“Medtronic recognizes the acute need for ventilators as life-saving devices in the management of COVID-19 infections. We know this global crisis needs a global response. Over the past few weeks, we have ramped up production of our Puritan Bennett™ 980 ventilators. But we also know we can do more, and we are,” said Bob White, executive vice president and president of the Minimally Invasive Therapies Group at Medtronic. “By openly sharing the PB 560 design information, we hope to increase global production of ventilator solutions for the fight against COVID-19.”
Ventilators play a critical role in the management of patients with severe respiratory illness, such as COVID-19, who require assistance because they cannot breathe effectively. By placing a patient on a ventilator, the patient’s lungs are permitted to rest and recover while the ventilator performs the functions of supplying oxygen and simulating the actions of breathing. Without ventilation support, some patients with severe respiratory disease might not survive.[/vc_column_text][/vc_column][/vc_row]
3DMEDiTech available for local device, part and component collaborations
[vc_row][vc_column][vc_column_text]Early reports from Europe and North America indicate that 3D Printing is uniquely capable of rapid local deployment to assist in preventing these shortages. However, when doing so, ensuring that the highest levels of clinical, engineering, regulatory and supply certainty are met is essential.
Based in Melbourne, 3DMEDiTech (www.3dmeditech.com) operates one of the only – and certainly the largest – ISO13485 certified medical 3DPrinting manufacturing facilities in Australia.
This facility has significant manufacturing capacity in a cleanroom environment and is completely geared to produce mass personalised medical devices.
3DMediTech and its constituent businesses units (SmileStyler and Serkel) stand ready to assist medical device companies to locally manufacture the devices and components our health system may urgently require as part of the national and global response to the pandemic.
3DMEDiTech CEO, Grant Enders said, “We think these collaborations will work best where medical device companies concerned about their supply chain work with us in advance to secure a solution which ensures seamless clinical efficacy and regulatory certainty.”
3DMEDiTech’s fleet of installed 3DPrinters includes:
- SLS (Selective Laser Sintering) equipment capable of printing medical grade plastic devices / parts.
- State-of-the-art PolyJet 3D Printing equipment platforms capable printing models and parts in a wide range of digital material configurations.
- High volume DLP (Moving-Light) acrylic photopolymer 3D Printing capacity which can be applied to many applications, like critical spare parts.
3DMediTech operates with a medical device-grade controlled cleanroom manufacturing facility. Their team of engineers are 3D Printing design and manufacturing veterans, and also have significant experience with Metal 3D Printing of medical devices.
The company’s clinical and research partners include Melbourne University and St Vincent’s Health Australia. they are foundation industry partners of the Australian Research Council Training Centre for Medical Implant Technologies “CMIT.”
3dMEDiTech co-founder Paul Docherty said, “3DMEDiTech’s core business is manufacturing Personalised Medical Devices where we have developed and own the IP and are the device sponsor. We do not normally seek contract manufacture of medical devices. This offer of collaboration is very much about our shareholders, board, management and employees wanting to actively contribute to the Australian MedTech sector’s ability to save lives during this crisis.”[/vc_column_text][/vc_column][/vc_row]
MedTech Industry Reels from Covid-19
[vc_row][vc_column][vc_column_text]The greatest impact comes through the cancellation of non-urgent elective surgery from 26 March. Companies were already reporting cancellation of elective surgery during March with specialist colleges such as the Australian Orthopaedic Association notifying that surgery would need to be scaled back.
However, the Prime Minister’s announcement that non-urgent elective surgeries would be cancelled from 26 March, with exemptions later provided until 1 April, means a dramatic overnight loss of revenue for many companies whose revenue is generated from the devices used in this type of surgery.
Category 3 surgeries include the following procedures in which prostheses and devices are heavily used:
- Total hip replacement
- Total knee replacement
- Shoulder reconstruction
- Cataract extraction (+/- intra-ocular lens insertion)
- Breast reconstruction (for reasons other than cosmetic)
While some more urgent Category 2 surgeries will be allowed, many prostheses or devices will be in the large majority that are now on hold.
Supply and freight costs have increased across the board, in some cases as much as 500%, as companies work to bring crucial medical supplies into Australia, with these impacts further exacerbated by the drop in the Australian dollar.
MTAA and its members are committed to the war effort, however, our industry is facing unprecedented challenges, both economically and in meeting the needs of the local supply chain.[/vc_column_text][/vc_column][/vc_row]
Medical devices industry COVID-19 update
[vc_row][vc_column][vc_column_text]As a member of the Coronavirus Industry Roundtable which is meeting regularly to discuss and address supply chain issues, MTAA has been asked by the Federal Government to lead the industry effort to coordinate the supply of essential medical equipment.
MTAA is coordinating with medical equipment suppliers and manufacturers, including non-members of MTAA, and other relevant industry associations to identify sources of supply and also to provide advice to Government regarding any constraints or obstacles to securing and maintaining supply. This includes identifying current stock, likely quantities that can be obtained through existing supply channels, new sources of supply and potential quantities, and opportunities to increase domestic manufacturing.
These groups will all be focused on providing the Federal Government with advice around supply chain and logistics issues, as well as working directly with state governments to gauge supply and the potential for shortages.
As part of maintaining the supply chain, MTAA is working directly with individual state governments to ensure that medical device services, including technical support and training, are able to continue to operate.
We are also working to ensure that vital technical support services, including service/maintenance/repairs and intraoperative technical support, can still be provided by technicians during medical procedures.
“We are incredibly grateful to the many medical technology companies dedicating significant resources to the effort at a time when their own companies are under an extreme amount of stress,” said Ian Burgess, MTAA CEO.
“The medical devices industry is 100% focused on helping to ensure the continued supply and distribution of vital medical supplies and maintaining Australia’s healthcare system,” Mr Burgess said.
TGA UPDATE
The medical technology industry has also been working closely with the TGA to enable faster access to life-saving medical equipment. A number of exemptions and fast-tracking processes have now been put in place:
- On 22 March 2020, an exemption was enacted to enable faster access to PPE. This will facilitate necessary access to certain kinds of medical devices that are used for the prevention, monitoring, treatment or alleviation of COVID-19. (In practice, disposable face masks, disposable gloves, disposable gowns, and protective eye wear in the form of goggles, glasses or visors, which are designed to be worn by individuals to prevent the transmission of organisms.)
- A new emergency exemption, Therapeutic Goods (Medical Devices—Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020, has been made to allow rapid supply of COVID-19 diagnostic tests to all Australian accredited pathology laboratories. In practice this emergency exemption allows COVID-19 diagnostic tests to be immediately supplied to accredited pathology laboratories approved under the Health Insurance Act 1973, while the TGA continues to expedite the regulatory assessment process for these devices.
- The TGA is currently undertaking an expedited assessment process based on the information and performance data currently available at the time of application for inclusion on the ARTG. All COVID-19 tests that are included on the ARTG based on this expedited assessment process are subject to additional non-standard conditions, which makes it easier for the TGA to perform additional post market assessments as experience and knowledge around COVID-19 diagnostic testing grows. The conditions require that additional evidence to support the ongoing safety and performance of the devices be provided to the TGA within 12 months of approval.
ACCC INTERIM AUTHORISATION TO SHARE INFORMATION
The ACCC has granted interim authorisation to MTAA to allow its members and other groups, such as suppliers or distributors of medical equipment, to share information between each other, co-ordinate orders and supply requests, prioritise requests, and jointly tender to supply COVID-19 medical equipment.
The interim authorisation will allow MTAA members and others to coordinate the manufacture and supply of equipment, and exchange information so that potential supply shortages can be addressed more quickly.
It will also allow industry to keep Federal Government, State and Territory Governments and relevant health agencies up to date on supply issues.[/vc_column_text][/vc_column][/vc_row]
DELAYED BUDGETS AND EXTENDED PARLIAMENTARY BREAK: WHAT DOES IT MEAN FOR BUSINESS AND INDUSTRY?
[vc_row][vc_column][vc_column_text]For business and industry, these changes not only affect the normal course of engagement with MPs and Senators, but it also gives an insight into the challenges that Government are facing with regards to the outbreak of COVID-19.
With this in mind, here are our thoughts on what these changes to the 2020/21 Budget and Parliamentary Sitting Calendar could mean for business going forward.
DELAYED BUDGETS
Due to the rapidly changing nature of the COVID-19 pandemic, Prime Minister, the Hon Scott Morrison MP, announced on Friday last week that the Federal Budget will be delayed until the first Tuesday in October – Tuesday 6 October 2020.
Treasurer, the Hon Josh Frydenberg MP elaborated on the decision to delay the Budget, stating that COVID-19 and its impacts on the economy were creating too much uncertainty for the Morrison Government to create a Budget that could accurately reflect Australia’s economic position.
In addition to the delay of the Federal Budget, all the states and territories have also indicated that they are also delaying their budgets due to the pressing nature of the COVID-19 response. At this stage, the states and territories have not indicated when their Budgets will be handed down, however, the Prime Minister has indicated that the states and territories will be working to similar timeframes.
EXTENDED PARLIAMENTARY BREAK
Following further restrictions due to COVID-19, the Parliament passed a revised Parliamentary Sitting Calendar to ensure that Parliamentarians, their staff and the staff of Parliament House minimize the risk of contracting COVID-19.
The biggest change in the new Parliamentary calendar is the removal of the May and June sitting fortnights in June, as well as the sitting week for the Budget in May 2020. At this stage, the Parliament is due to reconvene on 11 August 2020.
Business and industry should be aware that although the new Sitting Calendar indicates a Parliamentary return in August, the COVID-19 situation is ever-evolving and should it be necessary, the Parliament may make the decision to cancel further sitting weeks, should it deem it appropriate to safeguard the health of Parliamentarians and their staff.
WHAT DOES THIS MEAN FOR BUSINESS AND INDUSTRY?
KEY TAKEAWAYS FROM THE NEW PARLIAMENTARY SITTING CALENDAR
One of the key takeaways for business and industry is that the delay in reconvening Parliament can serve as an excellent indication of the timeframe that Government and key authorities are working towards with regards to COVID-19. Therefore, unless major positive developments occur in the interim, people should expect restrictions associated with reducing the spread of COVID-19 to remain in force at least until August 2020.
However, August 2020 is not a firm time for the lifting of restrictions and the Government has indicated should the COVID-19 situation not improve in the next few months, the Government will continue to enforce current restrictions. If the situation deteriorates, the Government has indicated that it will introduce tougher restrictions on people’s movement and interactions with other people.
IMPACT OF ECONOMIC STIMULUS ON BUDGET
With the regards to the delayed Budget, business and industry should be aware that this year’s Budget will drastically diverge from last year’s projections. Treasurer, the Hon Josh Frydenberg MP and the Morrison Government will likely to be focused on ensuring that continued stimulus is pumped into the Australian economy to avoid deep economic stagnation.
Many pundits are predicting that due to COVID-19, the Australian economy is likely to fall into recession (two consecutive quarters of economic growth) and should this occur, the Government will be concerned with ensuring that the effects of a recession have a minimal impact on the broader community. Currently, the Morrison Government has indicated that despite the nearly 200 billion in stimulus already announced, further stimulus packages could be released as the economic impact of COVID-19 evolves and changes.[/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?
- 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.
- 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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MEDTRONIC FOUNDATION COMMITS AN ADDITIONAL $10M TO GLOBAL COVID-19 EFFORTS
[vc_row][vc_column][vc_column_text]The Medtronic Foundation’s global and local response includes a comprehensive approach that is inclusive of cash contributions to over a dozen health and community nonprofits and will be used to fund:
- Training and supervising frontline health workers
- Ensuring the safety and well-being of frontline health workers, including provision of personal protective equipment (PPE) and critical supplies
- Supporting preparedness efforts for the health workforce, including surge capacity; caring for chronic, at-risk patients; and remote patient monitoring
- Offering local community support of health, economic and food assistance for vulnerable populations
- Providing flexible support to nonprofit partners working in underserved communities
“With roots in the world’s largest medical technology company, the Medtronic Foundation has a responsibility to be a leader on global issues impacting access to healthcare,” said Paurvi Bhatt, president of the Medtronic Foundation. “During this unprecedented global health crisis, we are committed to supporting and equipping the courageous frontline health workers who are delivering critical care to those in need. Through volunteerism and financial investments, we continue to partner with thought leading partners working globally, nationally and locally – with the flexibility and investment required to meet this critical need.”
In addition to financial contributions, the Medtronic Foundation is organizing virtual volunteer opportunities to help the more than 90,000 Medtronic employees globally support non-profit organizations that are responding to this global health crisis. Many of these opportunities will engage Medtronic employees in skills-based volunteerism where they leverage their professional skills to support organizations in need.
The Medtronic Foundation also will continue to match Medtronic employee donations to nonprofit organizations. These efforts will contribute to the immediate response, and as the situation evolves, the Medtronic Foundation will evaluate needs and consider additional contributions and volunteer opportunities as appropriate.
About Medtronic Foundation
Medtronic plc is the sole funder of Medtronic Foundation, whose focus is on improving health for underserved populations worldwide, as well as supporting communities in which Medtronic employees live and give. For more information, please visit medtronicfoundation.org.[/vc_column_text][/vc_column][/vc_row]
