MED TECH Europe have shared the attached HAI updated brochure. It is important to note that this is a revamp and update of an already existing information sheet, with new data, new calls for action (in line with our position paper) and a clear link made between AMR and HAIs. The brochure showcases the different medical technologies that can prevent and control HAIs throughout the patient pathway.
IMSTA SUBMISSION to Public consultation on draft guidance document relating to distribution of medical devices (including IVDs) completed.
Please follow links to view documents:
“This is a must see event for IMSTA members who want to compete for MES contracts in the future.”
THE FOLLOWING PRESENTATIONS ARE NOW AVAILABLE:
MES SEMINAR – Friday 21st April 2017
Registration – 10.00 to 10.30 a.m.
Venue – The Emmet Theatre, ARTS Building, TRINITY COLLEGE, Dublin 2.
No parking at venue, parking nearby in Setanta Centre.
Enter via Nassau Street Entrance.
For late registrations please contact Joanne on email@example.com
See Agenda here :MES Seminar Agenda
Justin Carty, CEO of IMSTA spoke with Irish Times journalist Sylvia Thompson
The cheapest product rarely gives customers the best value, according to Justin Carty, the CEO of the Irish Medical and Surgical Trade Association. Representing products ranging from bandages to CAT scans, Carty has to navigate a careful route when promoting the medical device industry to public and private hospital purchasers keen to get the best value for money with limited budgets.
But, as luck would have it, Carty’s agenda fits completely with the new EU public procurement directive. This 2014 EU directive presents a holistic analysis of value based health care which evaluates the entire life cycle, safety and effectiveness of products and not just the purchasing price. It also encourages the industry to define best price-quality ratio and to collaborate more closely with purchasers at the pre-tendering phase.
A recent report from the Boston Consulting Group, commissioned by Med Tech Europe (of which IMTSA is a member) presents a clear picture on how things need to change. Currently, most health care providers purchase medical products on the basis of the up-front purchase price, which, the consultants argue cloud the true cost of care.
The report includes insightful examples of what happens when broader criteria are used to purchase equipment. Take for instance, the Karolinska University Hospital in Sweden whose foutreen year tender for imaging services which included MRI, ultrasound and CT scanners; by tendering for imaging services rather than equipment, the contract included maintenance of technical standards, upgrades and replacement during the fourteen year period. Similarly, when the Stockholm County Council (which runs most of the city’s hospitals) sought tenders for wound care products, it asked suppliers to include calculations for the number of dressing changes, staff and transportation costs for changing these dressings. The winning bid was from the highest priced products which showed a lower cost of care over time.
The Boston Consulting Group report argues that smarter procurement such as these examples embraces a value-based framework that is aligned with the new EU directive. To include all the hidden costs of the equipment in terms of its durability and suitability to patient’s needs, the group suggests a calculation based on patient outcomes divided by the costs of achieving these outcomes.
Carty hopes this more holistic approach to procurement will be embraced by healthcare providers in Ireland. “This new procurement process focuses more on how to achieve better patient outcomes,” he says. Carty also suggests it would encourage clinicians to work more closely with the medical technology industry rather than leaving procurement decisions to those with their eyes firmly placed on the purchase price alone.
A natural extension of this approach would, according to Carty, be for healthcare providers to seek solutions to ongoing problems through industry competitions. This already happens in some countries such as the UK where the Small Business Innovation Research (SBIR) mechanism is used. There, NHS England’s SBRI Healthcare has worked with companies to come up with new solutions to problems in diverse areas such as diabetic foot ulcers, child and adolescent mental health and brain injury. The key element of effective SBIR programmes is that clinicians and front-line staff are the ones to identify the unmet need.
In his role as CEO of IMSTA, Carty proposed the SBIR model to a cross-departmental committee at Government level in 2015.
“We proposed that one to two per cent of the HSE non-pay procurement budget of €500 million could be ring-fenced to find solutions to identified healthcare problems,” he explains. The proposal was repeated in the IMSTA submission to the Oireachtas Committee on the Future of Healthcare in August 2016. As yet, the model hasn’t been embraced by the Health Services Executive.
Now, in 2017, Carty is keen to move the agenda forwards. To that end, Value-Based Healthcare Strategies is the theme of the IMSTA Annual Conference in the Crown Plaza Hotel, Santry on March 22. Confirmed speakers include Dr Tom Kelley from ICHOM, the International Consortium for Health Outcomes Measurement, Bill Maher, the CEO of the Bons Secours Hospital Group and Frank Sullivan, Adjunct Professor in Medicine and Director of Prostate Cancer Institute, NUIG. Throughout the conference, delegates will hear about the role of healthcare innovation in improving patient and clinical outcomes. Proposals for a new economic evaluation framework for medtech will also be discussed.
Ultimately, Carty is keen to spread the message about the role of medical technology companies in helping people live longer, healthier and more productive lives. “These life changing innovations also bring savings across the health care system by replacing more expensive procedures, reducing hospital stays and allowing people to return to work and home more quickly,” says Carty.
However, he adds a note of caution. “In order to understand the value and benefits of medical technology and ensure continued leadership of this industry, we must have the right public policies to support investment, innovation and patient access.”
Article for IMSTA Newsletter, Spring 2017
The Faculty of Nursing & Midwifery, Royal College of Surgeons in Ireland and IMSTA are delighted to announce a new innovative Credentialing Education Programme for Healthcare Industry Representatives (HCIRs) entering healthcare facilities for the purpose of conducting business. The programme aims to enhance the standards of training for HCIRs visiting healthcare organisations, provide assurance to health service and hospital staff and support public and private health service providers fulfil their duty of care to protect patients and ensure safe outcomes. Patient health, safety and confidentiality are the primary focus of the programme.
This bespoke blended-learning programme entitled: “HealthCare Industry Representative Credentialing Programme” will be delivered over 12 hours. The first four hours of the programme will be delivered, in one face-to-face in the RCSI at 9am, and finishing at 13.30pm.
A further 8 hours of content will be delivered on-line via the Faculty’s online “Moodle” Platform. These can be undertaken at a time and location convenient to the participant. Participants will be required to complete a short Multiple Choice Quiz (MCQ) on completion of the programme.
FEEDBACK FROM MEMBER WHO ATTENDED MARCH CREDENTIALING PROGRAMME:
“From an Industry Representative perspective, I feel it is very important to attend the course and attain the Credentialing Card, as our industry and the people we engage with on a daily basis require us to be ethical, compliant and, above all, be competent to ensure better patient care and patient outcomes.”
John Donovan, Sisk Healthcare /MED Surgical
Friday May 5th 2017, 9.00 a.m. in the RCSI, 123 St Stephen’s Green, Dublin 2. Register now below.
Friday 1st September 2017 9.00 a.m. Registration from Monday 8th May 2017.
Registration for May programme is available at http://www.rcsi.ie/fnm_cpdhcir.
Information on the programme is available on the CPD Programmes page of the Faculty’s website http://www.rcsi.ie/fnm_cpd
Requirements Prior to Acceptance on the Programme:
- Completed Application Form- This form contains a section, which must be completed by the Employer, signed, and dated;
Cost : €100.00 per participant
Further Information on this Programme
Ms. Catherine Clune Mulvaney
Operations & Education Manager
Faculty of Nursing & Midwifery
123 St. Stephen’s Green,
T: 01 402 5172 M: 087 6374002
Dear Medical Device Stakeholder,
Your industry representative body has kindly agreed to distribute the attached letter (attachment I) on behalf of HPRA.
The purpose of the letter is to inform stakeholders of the new fees that will be implemented from 1 January 2017 and to request contact information so that HPRA can contact organisations directly on the matter of fees.
We could be grateful if you could respond to devicefee@HPRA.ie with the necessary contact details or go to the following website:
Human Products Authorisation & Registration Dept
Health Products Regulatory Authority | An tÚdarás Rialála Táirgí Sláinte
Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2.
Tel: +353 1 676 4971
Fax: +353 1 676 7836
IMSTA joins Eucomed
Eucomed is an organisation advocating for the interests of the medical device industry in Europe. It represents directly and indirectly 4,500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and management of disease and disability. Eucomed represents a total of 11,000 legal entities in Europe. It is part of MedTech Europe, an alliance with EDMA, the European Diagnostics Manufacturers Association.
Among its members, there are 24 national medical technology associations and 62 medical technology companies, comprising approximately 70% of the European market. Eucomed has over 65 expert groups. These groups deal with regulatory, economic, public affairs, international and legal affairs topics. Eucomed represents several sectors within medical technology such as ophthalmology, cardiovascular medicine, orthopaedics, advanced wound care and Community Care.
Eucomed’s main mission is to advocate for the medical device industry at the European level. It engages with policymakers in European institutions and EU member states, patient groups, and medical associations. Eucomed regularly organises meetings and workshops for members and stakeholders. It lobbied extensively for the interests of the European medical device industry in the revision of the European medical device directive and advised IMSTA and IMDA in this regard.
IMSTA has been in touch with Eucomed since 2010, developing relationships with key personnel who have shared information on key trends and emerging position papers. John Brennan, Director of Technical & Regulatory Affairs, has been a good supporter of IMSTA. Prior to joining Eucomed John spent five years at the European Commission, having previously worked in and managed the Irish Notified Body, NSAI, where he gained extensive European and international experience in the design approval of high-risk medical devices and quality management systems.
IMSTA did not join Eucomed before now as the cost of membership was prohibitive relative to its’ value to IMSTA. We did however adopt Eucomed’s Code of Ethical Business Practice in 2011 and made it mandatory in 2013.
IMSTA’s CEO will spend the next 18 months engaging with Eucomed’s expert groups with a view to identifying how they can support the work of IMSTA nationally. It may be possible for Chairpersons of IMSTA’s working groups to engage with and participate in appropriate expert groups such as the Procurement Working Group or on Reimbursement. We intend to take full advantage of our membership and pass on the benefits of membership to our members.
The medical technology industry welcomes the vote on the consolidated medical device and in vitro diagnostics regulation texts by representatives of the Council and the Parliament on Wedneday 15th June.
The Environment, Public Health and Food Safety (ENVI) Committee of the European Parliament and Council’s Committee of Permanent Representatives (COREPER) voted to endorse the trilogue agreement. The texts can be downloaded and viewed on the European Parliament website – click here for more information.
MedTech Europe, the alliance of the medical device association Eucomed and the in vitro diagnostics association EDMA, continue to recognise the importance of these regulations towards the sector and the healthcare continuum at large.
“Medical technologies save lives, improve health and contribute to sustainable healthcare. Many of the proposed updates in the regulations are welcomed by our industry as they will enhance patient safety and facilitate access to new technology” says Serge Bernasconi, CEO of MedTech Europe. “I believe that the new regulations are critical in filling in the gaps of the existing laws and in bringing a more harmonised set of guidelines across the region”, he added.
EDMA and Eucomed have already begun working on an in-depth analysis of the regulations to assess the overall impact towards the industry. At the same time, EDMA and Eucomed are putting in place plans to provide active guidance and expertise for members to comply smoothly with the new regulations. IMSTA will put these Guidelines up on the members only section of our website in due course.
The consolidated texts are expected to undergo legal review and language translations in the coming months and are expected to be formally adopted at the end of 2016. The regulations would then apply to the medical devices and to the in vitro diagnostics sectors by 2020 and 2022 respectively.
Value-based health care is an emerging paradigm which has the power to change health care as we know it, but in order to achieve real impact, it must be applied to the key decisions that make up care delivery.
Several hospitals, procurement and even regional health authorities, have started including health care quality and longer-term cost impact considerations in their procurement decisions. That’s seems reasonable given that the public health system is there to provide for maintaining the health of the population. But what is meant by value? Value is not just about cost, but also and principally about broader patient health and societal benefits. Value is therefore a holistic concept.
One of the most critical decisions is the procurement of products or services by health care providers. By choosing one product or service over another, procurement officials are de facto impacting the care being offered and incentivizing the industry and other health care stakeholders to act in specific ways. Given this significant influence, procurement agencies should be one of the key players in health care leading the effort to focus on value. Value in health care is not about getting three for the price of two. This has enabled them to take health outcomes into consideration as well as other quality criteria, along with the total lifecycle cost and longer-term costs of care, so as to ensure best value for the patient, the medical staff, the entire hospital group and society.
It is further encouraging to note the increased focus the 2014 EU public procurement directive has placed on the quality criteria. This directive, which is currently being transposed into national legislations by the member states, puts clear focus on total economic value by making the most economic advantageous tender the default criteria and encouraging the use of best price/cost – quality ration i.e. the best value for money.
MedTech Europe in partnership with The Boston Consulting Group and international procurement experts, have been leading the way in developing a framework and tools to help health care providers evaluate the broader patient health and societal benefits when procuring health products or services.
At IMSTA’s Annual Conference ‘Embracing Technology in Value-Based Health Care’, Götz Gerecke, Managing Director and Partner of The Boston Consulting Group in Switzerland gave a presentation how BCG and MedTech Europe collaborated to create a framework and tool-kit to facilitate smarter procurement which will result in value and quality being included in tender evaluation in future. This will be a focus area for IMSTA in 2016 and beyond.
So, what does Value-Based Health Care actually mean? See the BCG/MedTech document BCG-Procurement-Dec-2015.
We have mentioned many times before that the Health Products Regulatory Authority (formerly the Irish Medicines Board – IMB) is about to introduce fees for distributors of medical devices. This will happen this year – 2016 – though the fees may only be payable from 1st January 2017, we’ll have to wait and see.
The reason the HPRA gives for the imposition of fees on distributors is “the introduction of fees at national level to recover the cost associated with our medical device regulatory activities”. The new EU Regulations governing the manufacture, sale and distribution of medical devices finally comes into force this year, possibly by as early as June 2016. The HPRA as the Competent Authority in Ireland is responsible for the monitoring of the safety and performance of medical devices throughout their lifecycle. In it’s role as market surveillance authority, the HPRA monitors medical devices after they are placed on the market and currently conduct audits at medical device manufacturing facilities, amongst other regulatory activities in this area. The Regulations will introduce new requirements and obligations for all economic operators, including distributors. As such, the HPRA will be required to monitor the compliance of medical device distributors with the requirements laid down in the Regulations, which are anticipated to essentially constitute Good Distribution Practice (GDP) for medical devices.
What will this mean for distributors? Apart from the annual fee, distributors will be subject to having their supply chain operations audited by the HPRA. So what will an audit entail? HPRA conducted a Pilot Inspection Programme for Distributors of Medical Devices recently with a view to determining an appropriate inspections protocol when they go “live” with distributor audits in 2017.
IMSTA have invited HPRA’s Darren Scully to provide an update on the distributor pilot inspections programme for medical devices – key findings and recommendations in line with the medical device revision as the text currently stands – at a business breakfast briefing on 11th May next. This is really important so register early, we’re anticipating a huge turnout. Confirm your attendance now by emailing firstname.lastname@example.org a.s.a.p.
We hope to be able to organise a follow-up business breakfast briefing shortly after the above which will be aimed at providing guidance on how members can comply with any recommendations the HPRA may have for distributors.