IMSTA Award Winner – ABBOTT DIABETES CARE – Approval given to reimburse FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM

As you may have heard at IMSTA’s Annual Conference, the Minister for Health Simon Harris TD welcomed the HSE PCRS’s decision to reimburse Freestyle Libre for children and young adults

Minister Harris said “Almost 190,000 people in Ireland have diabetes.  This is a chronic disease that takes a lot of management, but we have made huge strides in treating and managing diabetes here and I’m very happy today to welcome the HSE’s decision to reimburse Freestyle Libre for children and young adults.”

“This innovative device will allow blood glucose levels to be monitored without invasive finger prick testing, which will be very welcome news for both parents and children.  I know that some patients have to test their glucose levels up to ten times a day and I hope that inconvenience and discomfort can be minimised for as many children and young adults as possible.”

“This is another very positive step in the management of diabetes, along with the Diabetes Cycle of Care, which is a great example of how joined-up primary care and expanding the scope of general practice can be so effective in reducing hospital visits and admissions.  The Cycle of Care allows adult patients with Type 2 Diabetes, who hold a medical card or GP visit card, to be managed in the community, by their own GP and practice nurse, rather than in a hospital clinic.”

“We know from the National Healthcare Quality Reporting System (NHQRS) that hospitalisation rates that have decreased substantially for diabetes, and I want to see that downward trend continue.  My Department is progressing more work in the area – the National Clinical Effectiveness Committee (NCEC) prioritised the development of a Diabetes Type 1 clinical guideline for adults during 2017. The HSE’s National Clinical Programme for Diabetes plan to complete this guideline and submit to the NCEC for quality assurance early this year, and I hope to see it published soon after.”

“The HSE will now make arrangements for the reimbursement of Freestyle Libre on an individual basis where specific criteria are satisfied in line with the recommendations of the Health Technology Assessment Group and I look forward to its being available for patients in the coming months.”

An Expert Group, under the auspices of the HSE’s Health Technology Assessment Group (HTAG), considered the Free Style Libre application by Abbott for addition to the Reimbursement List in line with the Health (Pricing and Supply of Medical Goods) Act 2013.

The Health Technology Assessment Group recommended that reimbursement for the device should be considered, subject to certain conditions (see here for further information).

The HSE has accepted its recommendations in principle and will be developing an application suite for hospital clinicians to use when proposing suitable patients for consideration of individual reimbursement support.

This will be confined to children and young adults who require multiple dose injections of insulin in the first instance, with a review after twelve months. The HSE has indicated that it will take some months to build the application suite for reimbursement support which will be endocrinologist / Hospital Clinic initiated.

See Abbott winning their IMSTA AWARD here https://youtu.be/A3Nj85O6PTc

 

MedTech Europe Board Recommendations on Brexit

The Board of MedTech Europe has issuing the following recommendation to IMSTA/its members:

If you have any business interaction with the UK, consider this as a critical and urgent situation requesting all your attention. Anticipate business continuity plans including a “hard Brexit” scenario that should include no recognition of your UK CE marked products in the EU27 after the end of the transition period. This includes not only products originating in the UK but products from other countries who used UK Notified Bodies to gain CE marking, e.g. BSI (Italics added by IMSTA).

These plans need to take into consideration the possible delays in product re-certification by Notified Bodies due to the transition into the new Medical Device Regulation (2020) and IVD Regulation (2022).

The dynamic of the negotiations will evolve as we get closer to the end of the transition period and to a possible “cliff”.  Rest assured that MedTech Europe will continue to put all their effort in advocating their proposition up to and even after the end of the transition period. We will keep you informed on the evolution of the situation, which is fully monitored by the Board of MedTech Europe and its dedicated Brexit Task Force.

 

 

IMSTA supports MedTech Week 19-23 June 2017

#MedTechWeek 2017 activities out now! 

From 19 – 23 June   IMSTA , Medtech companies and Trade Associations from across Europe joined together to communicate the value that medical devices and in vitro diagnostics deliver to people, health systems and the wider economy.   IMSTA participated in several events during this week and the lightlights can be enjoyed below.

IMSTA are newest partners to donation scheme – The EQUALS Initiative.  The EQUALS Initiative was established between The Royal College of Physicians of Ireland and the HSE, and is based on developing strong links with hospitals while providing support according to the needs identified for equipment and training – 50 in-patient beds, 20 labour and delivery ward beds and 10 ultrasound machines being donated.  Details of the latest EQUALS Initiative were confirmed today as part of 2017 #medtechweek which is being hosted by IMSTA.

Speaking today, Justin Carty of IMSTA said: We are delighted to be on board with this positive and virtuous initiative as it continues to go from strength to strength. Many of our members in the medical technology sector would have supplied the equipment being donated and they will be heartened to know that it can still have a significant impact after being taken out of service in Ireland.   IMSTA’s access to medical equipment coupled with our bioengineering expertise can support the work of EQUALS in donating equipment and providing training in equipment maintenance in Zambia and other less developed countries.  This will enable hospitals in these countries to provide essential safe and high-quality health care which will address medical needs and save lives.”

“IMSTA recognizes the vital role of medical technology in contributing to the development of healthcare services and to address the unmet equipping and training needs in less developed countries.  Alike with our partners on EQUALS, we are deeply committed to the common goal of contributing to the improvement of global health.

Launching the new collaboration with IMSTA, Professor Frank Murray, President of the Royal College of Physicians of Ireland, said: “The healthcare and training needs are substantial in Zambia. We see opportunities to improve outcomes there in partnership with the authorities in Zambia. Healthcare equipment from Ireland has a huge potential to deliver benefits in Zambia. We look forward to collaborating with IMSTA to optimize opportunities to benefit Zambian patients. RCPI and HSE have developed a significant collaboration around training and equipment in this area, and the involvement of IMSTA has the possibility of bringing this to a higher level. It fulfills part of our mission statement to improve patient outcomes.”

Justin and Prof. Murray were interviewed afterwards on Newstalk’s Global Village programme and you can access the podcast here http://www.newstalk.com/podcasts/Global_Village/Global_Village_Highlights/197173/Health_in_Zambia.

To celebrate 2017 MedTech Week in Ireland, the Irish Medical & Surgical Trade Association (IMSTA) joined forces with global brand Vanilla Blush to showcase the company’s fashion and medical range of stoma underwear for patients.

Justin Carty, CEO of the Irish Medical & Surgical Trade Association (IMSTA) said: “Vanilla Blush’s specially designed underwear support and conceal stomas,  which greatly improves patient experiences allowing people with stomas to live full normal lives. IMSTA believes in supporting products which do just that.  Patient experience matters and is proven to effect health outcomes. Vanilla Blush products are available in the NHS but they are not reimbursed in Ireland by the HSE’s Primary Care Reimbursement System (PCRS). One has to ask why? It is our hope that this will change and these products will be reimbursed to Irish patients in time.”

Nicola Dames, the Dublin-born Vanilla Blush CEO, added: “We all have specialised individual needs. And we all have individual medical technological help. I so happen to need additional support with my Stoma. Other people need other help. This is what I call a normality of needs.”

Justin Carty, IMSTA, participated in a roundtable discussion, hosted by Medtronic, to mark MedTech Week 2017 on Tuesday June 20th at Buswells Hotel.   

DUBLIN – June 20, 2017  82% of Irish men and women have said they want easier access to innovative surgical treatments to treat incontinence and support a better quality of life, according to new research by Medtronic plc (NYSE: MDT).

The research was carried out by iReach, on behalf of Medtronic to mark MedTech Week 2017, with 1001 people (48% male, 52% female) across Ireland sampled from the 26th May to 1st June 2017 using an online survey and a consumer panel.

The data, presented at a MedTech Week event, has also found that:

  • Just 35% would be comfortable reporting their incontinence problems to a nurse, 32% to a consultant, 14% to a friend and 11% to a physiotherapist. Just 39% of adults surveyed would be comfortable talking about their incontinence to a family member and 14% to a friend.
  • 55% of respondents are likely to accept non-invasive surgical treatment in order to resolve issues with incontinence, with 50% of respondents also willing to consider physiotherapy;
  • Compared to all cohorts, middle-aged adults are most likely to favour non-invasive surgical treatments, with 61% of males selecting this treatment option as a means to resolve issues with incontinence;

To celebrate MedTech Week 2017, Medtronic also hosted a roundtable discussion to consider the research findings with patient groups, clinicians and representatives of the medical technology sector.  Participants emphasised that incontinence remains an under-treated condition as Irish patients remain uncomfortable in seeking treatment, as the research has revealed, and supported a call for the Irish healthcare system to harness the potential of innovative incontinence treatments to enhance patient outcomes. There was also agreement in calling for the optimisation of care pathways to ensure the most comprehensive treatments for pelvic floor disorders are available to patients in Ireland.

In a subsequent parliamentary exhibition, which was attended by TDs, Senators and patients, innovative bladder and bowel control therapies enabled by medical technology were put on display. Attendees were also given a first-hand account of how the use of such therapies can bring about significant improvements in the quality of life of incontinence sufferers. 

Speaking at the event, Dr. Mary Pat Fitzgerald, Consultant Gynaecologist at Bon Secours Hospital Galway, said: “Bladder control problems can significantly impair the quality of our lives, and as our discussions today have shown many patients are too embarrassed or uncomfortable to talk about the problem with a medical professional. It is critically important that we bring this condition out in the open so another generation does not suffer in silence.”

Dr. Eleanor Faul, Consultant Colorectal Surgeon at the Mater Misericordiae University Hospital said: “Today’s event is much needed to raise awareness of incontinence and the range of innovative therapies that are available for Irish patients. Technological advancements are enabling the development of new treatment options for those suffering with a loss of bowel control. Moreover, the clinical benefits of surgical technology are clear; they often relieve symptoms when other treatments fail and give a new lease of life to silent sufferers across Ireland.” 

Jackie Fielding, Vice President UK and Ireland at Medtronic, said: “MedTech Week 2017 is an important opportunity for Medtronic to highlight the value of medical technologies. Ireland has a leading role in the vibrant European MedTech industry and there is a need to draw greater awareness to the innovative surgical treatments available. We hope that by partnering with patient groups and clinicians in Ireland in the area of incontinence our MedTech Week event will help bring greater attention to the options available to those affected by incontinence to ensure they no longer suffer in silence.”

National Medical Device eAlert System

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A newly developed National Medical Device eAlert System designed to streamline the management of medical device safety notices within the public health system was launched at the Royal College of Physicians in Ireland on November 30th.  Developed by the HSE National Medical Devices Equipment Management Committee, in collaboration with the Quality Improvement Division (QID) and with assistance from the Health Products Regulatory Authority (HPRA), the aim of the eAlert system is to provide each HSE or HSE-funded voluntary service location assurance in the management of medical device safety or quality related notices issued by the HPRA.

The occasion also saw the launch of a HSE Medical Device Management ‘Quality Assessment and Improvement Tool (QA+I tool)’ to facilitate assessment against the HSE Medical Device Equipment Management Policy and Best Practice Guidance.  A key component of the medical device vigilance system is the dissemination of information, which may be used to prevent recurrence of an incident or to alleviate the consequences of such incidents.  As the national competent authority for medical devices, the HPRA publishes notices relating to the safety and/or quality of medical devices on its website www.hpra.ie. The majority of these notices are for the attention of health professionals including those working in hospitals, community healthcare organisations and other health facilities.

The national eAlert system receives notification directly from the HPRA of all safety notices or any internally generated HSE safety notifications for distribution.  A priority level is assigned to each alert in accordance with the HPRA traffic light system of red (Priority 1, most urgent), amber (Priority 2) and green (Priority 3, least urgent).  The medical devices eAlert system has been implemented and is available throughout the HSE and voluntary hospitals. T he web-enabled system is hosted by the HSE’s ICT centre and will facilitate the nomination of a ‘designated person / vigilance officer’ within hospitals, community healthcare organisations and other health facilities to take responsibility for the receipt of the medical device alert notifications. The ‘designated person / vigilance officer’ will ensure the further internal facility distribution to the relevant personnel for implementation of the recommended actions where applicable.  An automated response timescale (associated with the priority level) is also assigned by the HSE to each notification within which the relevant action must be reported back by the designated person / vigilance officer to the central ICT system as having been completed, or not being applicable, or some other outcome was required.  The eAlert system provides for an extremely efficient method of disseminating safety information to key medical device users and will contribute to enhanced patient safety across all the health facilities involved.

Healthcare professionals and medical device users are reminded to remain vigilant for field safety notices issued by medical device manufacturers as these will not be circulated via the eAlert system. The HPRA will continue to upload a monthly summary of field safety notices known to affect the Irish market on the website www.hpra.ie. As part of its ongoing work to encourage user reporting, the HPRA in collaboration with the QID and Medical Device Equipment Management Committee developed a Step-by Step guide to facilitate users in reporting medical device adverse events.  This guide was also launched on November 30th and will be circulated to all users in the Acute Service and the Community Healthcare Organisation in early 2016.  Relevant guidance is available for download from www.hpra.ie.

Minister Announces Hospital Groups and Publishes The Framework for Smaller Hospitals

The Minister for Health, Dr. James Reilly TD today (Tuesday, 14 May, 2013) announced a reorganisation of public hospitals into more efficient and accountable hospital groups that will deliver improved outcomes for patients. This represents the most fundamental reform of the Irish acute hospital system in decades.

The Government’s decision regarding the establishment and operation of the new hospital groups was informed by two reports – ‘The Establishment of Hospital Groups as a Transition to Independent Hospital Trusts’, produced by an expert group led by Professor John Higgins following consultation with stakeholders, and ‘The Framework for Development – Securing the Future of Smaller Hospitals’. Both reports were published today. These reports fulfil important commitments in Future Health, the strategic framework for reform of the health service which was published last November.

Hospital Groups

By working in groups, hospital services will be provided by the hospitals in each group, based on the evidence based needs of their populations. Each group of hospitals will work together as single cohesive entities managed as one, to provide acute care for patients in their area, integrating with community and primary care. This will maximise the amount of care delivered locally, whilst ensuring complex care is safely provided in larger hospitals. Six hospital groups will be established as follows:

  • Dublin North East;
  • Dublin Midlands;
  • Dublin East;
  • South/South West;
  • West/North West;

Each group will comprise between six and eleven hospitals and will include at least one major teaching hospital. Each grouping will also include a primary academic partner in order to stimulate a culture of learning and openness to change within the hospital group. Robust governance and management structures will be put in place at group level.

Benefits for Patients

The objectives of the groups are to:

  • achieve the highest standard of quality and uniformity in hospital care across the group;
  • deliver cost effective hospital care in a timely and sustainable manner;
  • encourage and support clinical and managerial leaders;
  • ensure high standards of governance, both clinical and corporate and recruit and retain high quality nurses, NCHDs, consultants, allied health professionals and administrators in all our hospitals.

The introduction of groups will provide for organisational change in the first instance, giving more autonomy and better enabling the reorganisation of services in a well-planned manner. Over time, this will help to improve services and deliver better outcomes for patients.

Speaking at the launch, Minister Reilly said: “The establishment of hospital groups signals a fundamental modernisation of our health system organisation in line with best international practice. The new hospital groups, each with their own governance and management, have been designed so as to provide the optimal configuration for hospitals to deliver high-quality, safe patient care which is cost effective and guarantees better outcomes for patients.”

Framework for Smaller Hospitals
The Framework for Smaller Hospitals outlines the need for smaller hospitals and larger hospitals to operate together and is therefore intrinsically linked to the formation of sustainable hospital groups. Better co-operation between hospitals will help to maximise the amount of care delivered locally.

Speaking on this issue, the Minister said: “Hospital groups will secure the future of our smaller hospitals. When the new groups are established, services can be exchanged between sites. This will result in the maintenance of activity in smaller hospitals and will allow them to focus on the provision of care that is safe and appropriate”.

Next Steps – Implementation
To complement implementation of the Report’s recommendations, the Department of Health will now put in place an overarching policy framework to guide overall hospital services reorganisation from a national standpoint. Work on the roll-out of hospital groups will commence immediately and will be overseen by a National Strategic Advisory Group and driven by the HSE. Group Chairpersons and CEOs will be appointed as soon as possible and preliminary governance arrangements will be put in place.

Initially the groups will be established on a non-statutory administrative basis. Each group must develop a strategic plan for their future service configuration in the first year of their operation. These plans must describe how they will provide more efficient and effective patient services; how they will reorganise these services to provide optimal care to the populations they serve; and how they will achieve maximum integration and synergy with other groups and all other health services, particularly primary care and community care services.

Following a rigorous evaluation of each group to ensure it is fit for purpose to function as a Hospital Trust, legislation will be put in place in 2015 to enable Independent Hospital Trusts to be established, taking account of any changes to groups which may emerge from the review process.

The Minister said: “I am very pleased that Professor Higgins has agreed to stay on until the end of June to work on the initial implementation phase in the establishment of the groups. He will return to his work in Cork but will continue to play a part in overseeing implementation as a member of the National Strategic Advisory Group. Today represents a major milestone in the Government’s health reform programme. I would like to thank Professor Higgins, the Strategic Board and the Project Team as well as those who participated in consultations. I look forward to working with all of the stakeholders to implement hospital groups so that we can deliver the best possible service for patients.”

Professor Higgins said: “We have a wonderful opportunity to make a step change within the Irish hospital system. We need to draw down the enthusiasm, the expertise and the experience of our all our staff. Working together we can deliver real change.”

Tony O’Brien, HSE Director General Designate said: “Today’s announcement is the most significant development in the organisation of our hospital services since the development of the cancer centres. This is an ambitious and well considered step towards ensuring that Ireland has a high quality, well organised and cost effective framework for the provision of acute hospital services to meet the changing needs of our population. Today marks the beginning of a journey towards a new way of governing and organising our hospital services and the HSE is committed to ensuring that this transition is managed as effectively, safely and swiftly as possible. The HSE will ensure the greatest degree of support is provided to each of the hospitals within the planned groups to ensure that they can each participate in the development of appropriate shared governance arrangements which will maximise the benefit to the communities that they serve. I look forward to supporting these hospital groups as they become established on an administrative.

basis on their journey towards full trust status.

NOTES FOR EDITORS
Report on Hospital Groups and Consultation with Stakeholders

The proposals on hospital groups are based on the recommendations of a report on the subject, produced by a panel of national and international experts led by Professor John Higgins. The report was informed by consultation with: management and senior clinicians from hospitals; patient advocates; health agencies; and the clinical programmes among others. Detailed data analysis also informed the report recommendations.

Number and Composition of Hospital Groups

No.       Recommended Composition of Hospital Groups

i           Dublin North East: Beaumont Hospital; Our Lady of Lourdes Hospital, Drogheda; Connolly Hospital; Cavan General Hospital; Rotunda Hospital; Louth County Hospital; Monaghan Hospital. (Academic Partner: RCSI).
 
ii           Dublin Midlands: St James’s Hospital; The Adelaide and Meath Hospital, Dublin, including the National Children’s Hospital; Midlands Regional Hospital, Tullamore; Naas General Hospital; Midlands Regional Hospital Portlaoise; the Coombe Women and Infant University Hospital. (Academic Partner: TCD).
 
iii          Dublin East: Mater Misericordiae University Hospital; St Vincent’s University Hospital; Midland Regional Hospital Mullingar; St Luke’s General Hospital, Kilkenny; Wexford General Hospital; National Maternity Hospital; Our Lady’s Hospital, Navan; St Columcille’s Hospital; St Michael’s Hospital, Dun Laoghaire; Cappagh National Orthopaedic Hospital; Royal Victoria Eye and Ear Hospital. (Academic Partner: UCD).
 
iv          South/South West: Cork University Hospital/CUMH; Waterford Regional Hospital; Kerry General Hospital; Mercy University Hospital; South Tipperary General Hospital; South Infirmary Victoria University Hospital; Bantry General Hospital; Mallow General Hospital, Lourdes Orthopaedic Hospital, Kilcreene. (Academic Partner: UCC).
 
v           West/North West: University Hospital Galway and Merlin Park University Hospital; Sligo Regional Hospital; Letterkenny General Hospital; Mayo General Hospital; Portiuncula Hospital; Roscommon County Hospital. (Academic Partner: NUIG).
 
vi          Midwest: Mid-Western Regional Hospital, Limerick; Ennis General Hospital; Nenagh General Hospital; St John’s Hospital Limerick; Mid-Western Regional Maternity Hospital; Mid- Western Regional Orthopaedic. (Academic Partner: UL)..
 
Note: The acute paediatric services in Dublin; Our Lady’s Children’s Hospital – Crumlin, Children’s University Hospital Temple Street, and the paediatric service in AMNCH – Tallaght should also function as a single cohesive entity with appropriate governance arrangements (in line with hospital group proposals).

National Strategic Advisory Group
The National Strategic Advisory Group will provide guidance and on-going direction in relation to implementation of both the Hospital Groups Report and the Smaller Hospitals Framework. It will also provide a forum to resolve issues and assist in the development of specific implementation guidelines on the steps required for full implementation.

Governance and Management of Hospital Groups
The Hospital Group Report makes recommendations in relation to governance, key leadership posts within the management teams, and key management functions of hospital groups.

Each hospital will be established on an administrative basis during an interim period. The hospital groups will each establish an interim group board to which the management team will report. The Chair of the interim board will be appointed by the Minister. The Chair will then nominate the board membership for Ministerial approval. The interim group board will comprise the necessary skills, competencies and experience to enable them to contribute to and challenge the performance of the hospital group. This experience and expertise will include clinical, business, social, legal, medical academic and patient advocacy.

Each of the groups will be led by a group Chief Executive Officer who will be the accountable officer for the group. The requirement for individual hospital management teams will be determined by the size of the hospital and the range of services provided at each site. However, the management teams of hospital groups must comprise the following key posts: Group Chief Executive Officer; Chief Clinical Director; Chief Academic Officer; Chief Director of Nursing; Chief Finance Officer; and Chief Operations Officer.

European Parliament approves committee report, paving the way to achieve balanced EU rules on medical devices

Plenary session endorsed essential measures that strengthen patient safety and improved the approaches on the approval system. The vote still leaves significant questions regarding the safety level for re-processing of medical devices. Overall, with this vote Parliament creates a good basis for constructive discussions and further improvements with Member States.

Brussels, 22 October 2013 – Eucomed, the European medical technology industry association, welcomes the majority of measures adopted today in a plenary vote by the European Parliament on the revision of the EU Medical Devices Directive (MDD). Members of the European Parliament (MEPs) have voted for much-needed measures to improve Europe’s notified body system, increase the transparency and traceability of medical devices, introduce unannounced site visits and provide for better stakeholder involvement.

On the approval system for medical devices, Eucomed positively notes that Parliament has shifted the approach and direction to a more manageable process without compromising the shared goal of improving patient safety. On the reprocessing of single-use medical devices, by adopting a variety of different elements, some newly introduced at Plenary, the approach taken still leaves significant concerns for patient safety as well as legal inconsistencies. For example, reprocessors are not subject to any conformity assessment. This seems at odds with the European Parliament’s stated desire to install a high level of patient safety throughout Europe. All in all, Eucomed believes that this vote will send a strong signal towards Council that Parliament is interested in finding a balanced, implementable solution that guarantees both better patient safety and a vibrant and innovative MedTech sector.

Many measures pave the way to effectively improve the safety for patients and are fully supported by industry. Eucomed now believes that Council and Parliament can concentrate on further improvements, in particular on the medical device approval system, re-processing of medical devices, appropriate clinical requirements and a sensible and scientific approach to hazardous substances.

Industry holds the opinion that the Parliament has improved some very essential elements of the approval system, such as clarifying roles and responsibilities of authorities, the Medical Device Co-ordination Group (MDCG), and clinical experts; ensuring Member States authorities are managing the ‘scrutiny’ system, introducing the concept of utilising a small group from a pool of independent scientific experts to support the MDCG in their decision making and installing high-level expertise and quality amongst Notified Bodies. Eucomed believes that further improvements in the discussions with Council should look at building the scrutiny process into the upgraded notified body approval system and not adding it on top of or afterwards which would double or even triple the level of bureaucracy in an already improved system. Also, the scrutiny should avoid any sort of cherry-picking or random ‘needle-in-the-haystack’ approach. Eucomed also listened with interest to Commissioner Mimica’s comment in Plenary that after trust in the quality and competence in Notified Bodies has been built, a move could be feasible from a pre-market product scrutiny to a post-market system scrutiny based on post market controls.

MEPs also gave a strong signal on the reprocessing of single-use medical devices by not following the full ENVI proposal whereby medical devices such as syringes would be reusable by default. Unfortunately neither did they revert to the balanced Commission proposal. Instead they adopted a hybrid approach that still leaves significant concerns for patient safety. For example, reprocessors are not subject to any conformity assessment. This seems at odds with the Parliament’s stated desire to install a high level of patient safety throughout Europe. Furthermore, in defining ‘single-use devices’ Parliament kept the practically un-implementable approach to legally and scientifically require manufacturers to prove the impossibility of reprocessing, which is an impossibility in itself. There are also other legal inconsistencies inherent in the adopted reprocessing text.

The next phase in the legislative process should tackle these and the more technical aspects, to ensure that all measures are appropriate, applicable and implementable for authorities and stakeholders. Top of the list here would be further improving the ‘scrutiny’ mechanism, re-processing of medical devices, appropriate clinical requirements and a sensible and scientific approach to hazardous substances.

“The Parliament has voted for many improvements that will effectively improve patient safety. We believe that this paves the way for further needed improvements to be discussed with the Council. We congratulate the Parliament in finding more clarity and positive approaches in important areas supporting safety of patients and innovation for patients in what has been a very complex and highly technical dossier. We are looking forward to seeing continued evolution on a future strengthened EU framework for medical devices.” said Eucomed Chief Executive Officer Serge Bernasconi.

Niall MacAleenan, Clinical Assessment Manager, IMB, gave a very timely presentation to IMSTA members at our recent Business Breakfast on the implications of these regulations for distributors in Ireland. A copy of his presentation is below.

131022_IMSTA_BreakfastBrief

Minister Reilly publishes eHealth Strategy for Ireland

30.01.2014

The Minister for Health, Dr James Reilly TD, published the eHealth Strategy for Ireland, the Health Identifiers Bill 2013 and announced the recruitment of a Chief Information Officer for the health services.

“The eHealth Strategy will put Ireland in a position to fully exploit all of the many benefits which today’s information and communication technology has to offer in modernising the way we treat patients and particularly in providing care in the most appropriate setting and at the most appropriate level within the health services” said Minister Reilly. “From my perspective, the eHealth strategy could not have come at a better time because eHealth is a key enabler of change, the type of radical reform that we have put in train for our health services. I am also pleased by the proposals for cooperation with Northern Ireland in this area”.

The Health Identifiers Bill 2013, published today, provides the legal basis for Individual Health Identifiers for health service users and unique identifiers for health service providers. The identifiers will be used across the health service, both public and private.

First and foremost, Individual Health Identifiers are about patient safety and ensuring that the right information is associated with the right individual at the point of care. Individual Health Identifiers will also help in managing our health service more efficiently and will be a building block for health reform initiatives outlined in Future Health, including Money Follows the Patient.

A dedicated branded entity called ‘eHealth Ireland’ will be established, initially in the HSE. It will be headed by a Chief Information Officer for the health service who will be recruited through an open competition. Priority areas for initial development include ePrescribing, online referrals and scheduling, Telehealth (particularly relating to the management of chronic disease) and the development of summary patient records.

The Individual Health Identifier provided for in the Health Identifiers Bill will be essential to all of these developments and a programme for its rollout will be prepared as a matter of priority in tandem with the passage of the Bill through the Oireachtas.

eHealth Ecosystems will be a key mechanism for delivering on the eHealth strategy. These will involve partnerships between health service providers, academia, industry and patients. Such eHealth Ecosystems have been established in a number of EU countries and are amenable to cross border cooperation. The Irish Presidency Declaration at the EU eHealth Conference held in Dublin in May 2013 committed member states to developing eHealth Ecosystems.

Concluding the Minister said “I firmly believe that Ireland’s extensive IT and healthcare industry sectors make us very well placed to exploit eHealth, not just to radically improve our own health services, but as an emerging area within the wider ICT industry which will have a significant part to play in achieving this Government’s targets for jobs and economic growth.”

A copy of the eHealth Strategy for Ireland is available at www.dohc.ie/publications/eHealth_Strategy_2013.html

ENTERPRISE IRELAND Innovation Partnership for Medical Device and Associated Companies

Background to the Opportunity for Companies

In the last 20 years, the Irish Medical Device and associated sectors have been a major success, showing strong growth in both indigenous and multinational companies.

Among the established subsectors in Ireland are Cardiovascular and Cardiac Rhythm Management, Orthopaedics, Opthalmic and in vitro and in vivo Diagnostics.

While maintaining leadership in manufacturing excellence, Ireland is growing capability in product and service development.

Supporting multinational and indigenous companies to improve productivity, broaden product portfolios, and increase technological diversity are vital activities and the Innovation Partnership Programme is a key means to achieve this.

Trends Driving Innovation

As technologies evolve and markets change, Ireland is striving to maintain and sustain this significant sector. Some of the trends that are driving innovation include:

The rise of new technologies capable of integrating medical devices into a connected platform enhances the functionality of devise, reduces man power burden, and minimizes errors.

Due to price sensitivity and availability of floor space, highly specialised pieces of equipment are losing out in purchase decision making to versatile systems capable of addressing multiple needs.
The amount of health care data being captured due to recent IT infrastructure upgrades is expected to greatly enhance ‘smart’ and AI functionality for diagnostic and treatment device.

Cost containment initiatives are spurring new types of innovation in medical technologies that provide comparable diagnostic and therapeutic utility at fractions of the cost.

Improved or highly novel materials/surfaces in medical devices provides the benefits of biocompatibility and functionality at an unparalleled scale, allowing it to be better able to influence diseases.

Increased collaboration between biopharma, ICT and medical device companies in the area of drug delivery technologies.

Medical Device – Research Capability in Ireland

Ireland has been and continues to invest heavily in research capability that services Medical Device needs. Just some examples of the research capabilities include:

Applied Polymer Technologies

Irish Centre for Manufacturing Research (ICMR)

Biomechanics Research Centre

Materials Research Institute

Bioscience Research Institute

Materials & Surface Science Institute

Centre for Applied Biomedical Engineering Research

Medical Engineering Design and Innovation Centre (MEDIC)

Enterprise Research Centre – Engineering Knowledge Group

National Centre for Biomedical Engineering Science

Galway Medical Technology Centre

Network of Excellence for Functional Biomaterials

INSIGHT Centre for Data Analytics

Tyndall National Institute

Irish Centre for Composites Research

Wireless Sensor Applied Research (WiSAR)

Collaboration supported with Innovation Partnership Funding
Enterprise Ireland’s Innovation Partnership Programme can provide up to 80% of the cost of a research project, to work with the research groups named above and others in Irish research institutions, on a Medical Device or associated project defined by your company, to help your company.
To find out how an Innovation Partnership project could transform your business, please Contact

Declan McGee
Programme Manager
Innovation Partnership Programme
Enterprise Ireland
Tel. +353 1 727 2668

declan.mcgee@enterprise-ireland.com

Medical Device Legislation Update

4.09.2014

The Commission Formal Proposal published in September 2012 is expected to be adopted as new legislation by the end of next year, 2015. The final shape of the legislation is far from decided at this point in time and what will finally emerge will probably be quite different from what we have today.

One of the significant changes is that the role and number of Notified Bodies will be different. They will be expected to carry out unannounced audits at least once every three years and more frequently for high risk products. Manufacturer’s critical suppliers will also be subjected to this process.

Processing of single use devices remains a difficult area. All credit to the Commission for an attempt to bring this into line using the fundamental principal that anyone who reprocesses a device must take on the full responsibility of the manufacturer. Some member states are resisting this and the European Parliament (EP) are making things worse by proposing that all devices are reusable by default.

The system proposed for clinical investigati9ons will also add to manufacturer’s costs with the EP proposing randomized controlled trials (RCTs) for devices. A lot of work is needed to convince people that this is not appropriate. A recently published Commission report in the Joint Action Plan calls for and implements improvements to the system in advance of the new legislation. This includes the unannounced audits by Notified Bodies mentioned above but also addresses issues around vigilance and post market surveillance, a key area which was identified as central to any improvement as far back as the 2008 report. This is being actively addressed across the EU with major Competent Authorities, including the HPRA taking a lead. Improvements here are key to a better system in the future but don’t forget that it will also mean more cost all round.

One major change which flows from more general EU legislation is the greater control that will be imposed on players in the supply chain (knows as Economic Operators). This will mean that the activity of importers and distributors will now come under greater scrutiny and surveillance. Each actor in the supply chain will need to verify compliance with his supplier. Industry is trying to ensure that this is done in a sensible way, resisting calls for complicated labelling regimes. In a related area the rules on own branding will almost certainly change meaning that those selling a products under their own name (but made by someone else) will face significant extra costs.

UDI is a key component of the proposed new legislation on medical devices and is seen by many in the broader healthcare community as the answer to a wide diversity of problems. Many, including those working on the legislation, see it as a ‘done deal’; something which will be implemented in the fullness of time. Unfortunately this is not the case. On both UDI and the closely related question of the EU Database, there are instances of deviation and non-conformance by member states.