John Lahart
Question:364. Deputy John Lahart asked the Minister for Health if zero-hour contracts are being implemented for employees in the nursing home sector and if he will make a statement on the matter. [27095/22]
View answerNursing Homes
Questions (364)
Written answers
Contract details of employees in public residential care is an operational matter for the HSE. Accordingly I have referred the Deputy's question to the HSE for direct reply.
Departmental Schemes
Questions (365)
Éamon Ó Cuív
Question:365. Deputy Éamon Ó Cuív asked the Minister for Health if vertex for the treatment of cystic fibrosis will be made available under the general medical scheme; the reason that it is not available; and if he will make a statement on the matter. [27096/22]
View answerWritten answers
Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
Health Services
Questions (366)
Seán Sherlock
Question:366. Deputy Sean Sherlock asked the Minister for Health the amount that was paid by the HSE to recruitment companies in each month in each of the years 2016 to 2021 and to date in 2022; the specific areas for which these companies were recruiting in the health service; and the number of staff that were successfully recruited each month for the same period in tabular form. [27099/22]
View answerWritten answers
As this is a service matter, I have asked the Health Service Executive to respond directly to the Deputy, as soon as possible.
Departmental Investigations
Questions (367)
Bríd Smith
Question:367. Deputy Bríd Smith asked the Minister for Health if he will detail the progress on any investigation or report into the practice of the misuse and incineration of the organs of deceased babies; the steps that his Department is taking to ensure that this practice is not repeated; the meetings or consultations that are taking place with parents who have been affected with his Department or HSE officials; and if he will make a statement on the matter. [27108/22]
View answerWritten answers
In relation to the Cork University Hospital mortuary review, the Department has been advised by the HSE that the External Review Team is currently seeking legal opinion. Communication has issued to the families advising them of the further delay.
The Department is continuing to engage with the HSE in relation to progress on this matter.
As this Parliamentary Question relates to an operational matter it has been referred to the HSE for direct reply to the Deputy.
Mental Health Services
Questions (368)
Bernard Durkan
Question:368. Deputy Bernard J. Durkan asked the Minister for Health the extent to which it is envisaged that deficiencies in CAMHS can be identified; the extent to which it is intended to address these issues in the short-term; and if he will make a statement on the matter. [27116/22]
View answerWritten answers
As this is a service matter, I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
Hospital Waiting Lists
Questions (369)
Bernard Durkan
Question:369. Deputy Bernard J. Durkan asked the Minister for Health the extent to which it is expected to make serious inroads on hospital waiting lists throughout the country by whatever means; and if he will make a statement on the matter. [27117/22]
View answerWritten answers
The number of people on acute scheduled care waiting lists was already too high before the pandemic and now, following months of disruption to services, there are over 730,000 waiting for scheduled care in Ireland. In February of this year, I launched the 2022 Waiting List Action Plan, following extensive consultation between my Department, the HSE and the National Treatment Purchase Fund. With this Plan, €350 million has been allocated to the HSE and NTPF to provide additional public and private activity to further stabilise and reduce scheduled care waiting lists and times and bring forward much needed longer-term reform.
It is projected that 1.5 million people will be added to waiting lists this year. The Plan details how we intend to ensure that an even higher number, 1.7 million, are treated and removed from waiting lists. Therefore, if this Plan is fully delivered, it will reduce waiting lists by 18 percent this year which will bring the number of people waiting to 588,000, the lowest number in five years.
The Plan will also progress work towards the achievement of intermediate waiting time targets this year, as set out in the National Service Plan (of 18 months for OPD; 12 months for IPDC; and 12 months for GI scopes).
Additionally, there is a particular focus on 15 high-volume inpatient day case procedures, so that every person waiting for over 6 months who is clinically ready will receive an offer of treatment. These procedures include cataracts, hip and knee replacements, and angiograms.
Implementation of the Plan is well underway, with progress being monitored by a Task Force co-chaired by the Secretary General of my Department and the CEO of the HSE.
Health Services
Questions (370)
Bernard Durkan
Question:370. Deputy Bernard J. Durkan asked the Minister for Health the total number of patients currently seeking orthopaedic interventionism; the extent of any such waiting lists; and if he will make a statement on the matter. [27118/22]
View answerWritten answers
It is recognised that waiting times for scheduled appointments and procedures have been affected by the Covid-19 pandemic. While significant work continues to positively impact on waiting times and improve pathways to elective care, acute hospitals have been impacted by operational challenges arising from surges in cases related to the Omicron variants.
The HSE has confirmed to the Department that patient safety remains at the centre of all hospital activity and elective care scheduling. To ensure services are provided in a safe, clinically-aligned and prioritised way, hospitals are following HSE clinical guidelines and protocols.
The Department of Health continues to work with the HSE and the National Treatment Purchase Fund (NTPF) to identify ways to improve access to care, including through increased use of private hospitals, funding weekend and evening work in public hospitals, funding “see and treat” services, providing virtual clinics, and increasing capacity in the public hospital system.
The NTPF have advised my Department that to date this year they have approved orthopaedic outpatient and in-patient initiatives which will facilitate appointments for 11,287 patients on waiting lists. Details of these initiatives are provided in the attached document.
The 2022 Waiting List Action Plan, which was launched on the 25th of February, allocates €350 million to the HSE and NTPF to reduce waiting lists. Under this plan the Department, HSE, and NTPF will deliver urgent additional capacity for the treatment of patients, as well as investing in longer term reforms to bring sustained reductions in waiting lists.
The plan builds on the successes of the short-term 2021 plan that ran from September to December last year. The 2021 plan was developed by the Department of Health, the HSE and the NTPF and was driven and overseen by a senior governance group co-chaired by the Secretary General of the Department of Health and the CEO of the HSE and met fortnightly.
This rigorous level of governance and scrutiny of waiting lists has continued into this year with the oversight group evolving into the Waiting List Task Force. The Task Force will meet regularly to drive progress of the 2022 plan.
This is the first stage of an ambitious multi-annual waiting list programme, which is currently under development in the Department of Health. Between them, these plans will work to support short, medium, and long term initiatives to reduce waiting times and provide the activity needed in years to come.
The information requested by the Deputy in relation to the total number of patients currently seeking orthopaedic interventionism has been provided to my Department by the NTPF and is outlined in the attached document.
Orthopaedics, In-patient Daycase (IPDC) Waiting List, as at 28/04/2022
|
Time band (months) |
0-6 Mths |
6-12 Mths |
12-18 Mths |
18+ Mths |
Grand Total |
|
Apr-22 |
6,890 |
1,974 |
884 |
1,744 |
11,492 |
Orthopaedics, Outpatient (OPD) Waiting List, as at 28/04/2022
|
Time band (months) |
0-6Months |
6-12Months |
12-18Months |
18+Months |
Grand Total |
|
Apr-22 |
29,899 |
19,197 |
10,050 |
12,613 |
71,759 |
Orthopaedics, Outpatient (OPD) Waiting List, as at 28/04/2022
|
Time band (months) |
0-6Months |
6-12Months |
12-18Months |
18+Months |
Grand Total |
|
Apr-22 |
29,899 |
19,197 |
10,050 |
12,613 |
71,759 |
NTPF Insourcing Approved OPD Orthopaedic Proposals to date 24/05/2022
|
Hospital |
Volume |
|
St James's Hospital |
920 |
|
Mater Misericordiae University Hospital |
343 |
|
St Vincent's University Hospital |
2,160 |
|
South Infirmary Victoria University Hospital |
1,100 |
|
University Hospital Waterford |
1,900 |
|
Croom Hospital |
2,000 |
|
Total |
8,423 |
NTPF Insourcing Approved IPDC Orthopaedic Proposals to date 24/05/2022
|
Hospital |
Volume |
|
Letterkenny University Hospital |
300 |
|
Croom Hospital |
1,000 |
|
Beaumont Hospital |
85 |
|
University Hospital Galway |
71 |
|
National Orthopaedic Hospital Cappagh |
219 |
|
Kilcreene Hospital |
1,100 |
|
St Vincent's University Hospital |
70 |
|
Midlands Regional Hospital Tullamore |
8 |
|
South Infirmary Victoria University Hospital |
11 |
|
Total |
2,864 |
Emergency Departments
Questions (371)
Bernard Durkan
Question:371. Deputy Bernard J. Durkan asked the Minister for Health the extent to which he has identified the ten most-regularly overcrowded accident and emergency departments throughout the country; the measures that are being put in place to deal with the issue; and if he will make a statement on the matter. [27119/22]
View answerWritten answers
I acknowledge the distress overcrowded Emergency Departments cause to patients, their families, and staff throughout the country. I am committed to improving emergency services for all.
The Government invested an additional €1.1bn in budget 2021 to expand capacity, increases services and support reform. We maintained this level of investment in budget 2022. The Government invested a further €77 million in the 2021/22 Winter Plan. The Plan focused on addressing the causes of long waits in the ED.
In relation to question of the ten most-regularly overcrowded EDs, as this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
Health Services
Questions (372, 376)
Bernard Durkan
Question:372. Deputy Bernard J. Durkan asked the Minister for Health the extent to which he and his Department have identified the most serious deficiencies in the delivery of the health services; the plans that are in place to address these issues in the short-term; and if he will make a statement on the matter. [27120/22]
View answerBernard Durkan
Question:376. Deputy Bernard J. Durkan asked the Minister for Health when Sláintecare is likely to be implemented in-full; and if he will make a statement on the matter. [27124/22]
View answerWritten answers
I propose to take Questions Nos. 372 and 376 together.
The Government’s commitment to Sláintecare reform and to ensuring every patient receives the right care, in the right place, at the right time is absolute and unwavering. €1.235 billion was allocated to Sláintecare initiatives in Budget 2021 enabling and supporting major milestones in the implementation of Sláintecare and funding is continuing at historically levels in Budget 2022.
The Sláintecare Implementation Strategy & Action Plan 2021-2023 was approved by Government in May 2021. This is the second three-year strategy that aims to realise the vision of a universal single-tier health and social care system, where everyone has equitable access to services based on need, and not ability to pay. The Strategy focusses on two Reform Programmes, with eleven projects, for 2021 — 2023: Improving Safe, Timely Access to Care; and Promoting Health & Wellbeing and Addressing Health Inequalities. A mid-year progress report was published in September 2021 and an end-of-year Progress Report was published in February this year.
Implementation continued despite the challenges of the major cyber-attack on our health services and the ongoing COVID-19 pandemic. Substantial key achievements last year and this year to date include approval of the Government’s National Elective Ambulatory Strategy and progressing plans for new elective hospitals in Cork, Galway and Dublin; publication of the Business Case for Regional Health Areas to support the alignment of community and hospital services based on defined population need; and mainstreaming innovation through the Sláintecare Integration Fund.
New governance structures have been put in place, including the new Sláintecare Programme Board, co-chaired by the Secretary-General of the Department of Health and the Chief Executive Officer of the HSE, to ensure that implementation of Sláintecare is fully embedded and owned across the Department of Health and the HSE.
Work is being finalized on a detailed 2022 Action Plan in order continue to deliver on our Sláintecare commitments this year and this will be published in the near future. Key areas of focus this year will include addressing waiting lists, further developments in shifting care to the Community, further investment in innovation, enhanced capacity and access to care, implementing digital and eHealth solutions in line with Government’s recently published national digital framework “Harnessing Digital”, introducing the Sláintecare Consultant Contract, progressing the National Elective Ambulatory Strategy through the provision of new elective capacity in Cork, Dublin and Galway, and the realignment of acute and community services via Regional Health Areas.
Mental Health Services
Questions (373)
Bernard Durkan
Question:373. Deputy Bernard J. Durkan asked the Minister for Health the extent to which the concerns of parents of children with mental health problems are regularly monitored with a view to ensuring the availability of adequate residential places; and if he will make a statement on the matter. [27121/22]
View answerWritten answers
As this is a service matter, I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
Health Services Staff
Questions (374)
Bernard Durkan
Question:374. Deputy Bernard J. Durkan asked the Minister for Health the issues that he and his Department have identified as being the most crucial in ensuring the availability and retention of staff at various levels; and if he will make a statement on the matter. [27122/22]
View answerWritten answers
Under Action 25 of the Civil Service Renewal Plan, the Civil Service as a whole committed to carrying out a series of employee engagement surveys, the first of which was undertaken in September 2015. The most recent survey, coordinated by the Department of Public Expenditure and Reform, was conducted in 2020. The surveys are undertaken to help civil service employers to understand and build on the strengths and talents of the people who work in the civil service and to identify any challenges to inform any required actions to address those challenges.
The 2020 results for the Department of Health are consistent, in general terms, with the results for the wider civil service. For the Department of Health the 2020 results indicate a positive, upward trend in most themes compared to previous surveys and reflect the impact of departmental initiatives that have taken place since 2015. Survey measures such as involvement and innovation climate, leadership and performance standards are factors which have been shown to influence the retention of staff. These measures have seen improvements since the first survey was undertaken in 2015 and the Department is continuing to focus on these areas for further development through various initiatives.
Current projects and initiatives include a Culture Project, the development and introduction of a Blended Working Policy, health and wellbeing supports, learning and development opportunities, promotional opportunities and increasing engagement with staff through various networks, the encouragement of social activities and most recently, the establishment of the Equality, Diversity and Inclusion working group.
The Department manages its workforce planning via its governance structures and the availability and retention of staff is a matter of ongoing focus for the Department's senior management.
Hospital Facilities
Questions (375)
Bernard Durkan
Question:375. Deputy Bernard J. Durkan asked the Minister for Health the current position in regard to the future development plans for Naas General Hospital; the position in relation to planning permission and any other factors which might affect the issue of early provision of the accommodation required; and if he will make a statement on the matter. [27123/22]
View answerWritten answers
As the Health Service Executive is responsible for the delivery of public healthcare infrastructure projects, I have asked the HSE to respond to you directly in relation to this matter.
Question No. 376 answered with Question No. 372.
General Practitioner Services
Questions (377)
Bernard Durkan
Question:377. Deputy Bernard J. Durkan asked the Minister for Health the extent to which out-of-hours general practitioner services are sufficient in all areas throughout the country; the areas of most concern; the proposals for a resolution of same; and if he will make a statement on the matter. [27125/22]
View answerWritten answers
GPs contracted under the General Medical Services Scheme are required by their contract to make suitable arrangements to enable contact to be made with them, or a locum or deputy, for emergencies outside of normal practice hours. While there is no obligation on GPs to participate in GP out of hours co-operatives as a means of meeting the contractual requirement, such services facilitate the provision of GP services outside of normal surgery hours and help to spread the burden of this provision. Only a small number of areas are not covered by GP out of hours co-operatives, instead out of hours services are provided by local GPs.
The HSE is in regular contact with out of hours service providers. In particular, over the past two years there has been greater engagement to ensure that the services can continue to provide the supports needed by local communities. In recognition of the key role GP out of hours service providers play in the delivery of our health service and the challenges arising from the Covid-19 pandemic, a financial and service stability arrangement for GP Out of Hours cooperatives was introduced with effect from 14th March 2020.
GP out of hours cooperatives are private organisations. The HSE provides significant funding to support out of hours co-operative services through service level agreements; the HSE has responsibility for determining the allocation of funding from its budget. As the provision of out of hour GP services is a service, I have asked the HSE to respond to the Deputy directly in relation to regional GP out of hours service levels, as soon as possible.
Home Help Service
Questions (378)
Bernard Durkan
Question:378. Deputy Bernard J. Durkan asked the Minister for Health the degree to which homecare continues to be adequately staffed and supported in order to reduce pressure on hospitals; and if he will make a statement on the matter. [27126/22]
View answerWritten answers
The Government is committed to the development of improved community-based services, shifting care to the home, and offering greater choice for older people. As Minister with responsibility for this area I have prioritised home support services so that additional funding secured in Budget 2021, to provide an extra 5 million hours, has been maintained under Budget 2022. In 2021 some 20.4 million hours were provided to over 55,000 people. This is about 2.9 million more hours compared to 2020, an increase of 17%.
It takes some time between funding approval and the actual delivery of home support hours, and certain regions are experiencing increased pressures due to staff availability. Preliminary activity data shows that at the end of March 2022 over 5.1 million home support hours were delivered nationally to 55,080 people. Also, as of this date, there were 286 people assessed and waiting for funding for new or additional home support, while 5,458 people were assessed and approved for Home Support but are awaiting a carer to be assigned. As of 17 May, the HSE reported 90 patients nationally who are waiting to be discharged with home support.
The demand for home support and its importance as an alternative to long stay care has grown considerably over the past number of years. Delivering this enhanced capacity requires substantial recruitment. This has been affected due to the strategic workforce challenges in the home support sector. The HSE is endeavouring to prioritise service for clients with the highest care needs, to ensure that the service can commence for those who require it most urgently. The HSE continues to advertise on an ongoing basis for Health Care Support Assistants and to recruit as many suitable candidates as possible. Due to the nature of the role, this recruitment is normally conducted at a very local level.
I am very aware of the strategic workforce challenges in the home support and nursing homes sector, and I have held multiple meetings with relevant key stakeholders in recent months on these matters. I have established a cross-Departmental Strategic Workforce Advisory Group to examine strategic workforce challenges in front-line carer roles in home support and nursing homes. The Group provides a forum for agreement on strategic approaches to address the workforce challenges in the sector nationwide. Later this year the Group will provide me with a set of recommendations based on its key findings, and a proposed action plan to support implementation of these recommendations.
Dental Services
Questions (379)
Bernard Durkan
Question:379. Deputy Bernard J. Durkan asked the Minister for Health the extent to which orthodontic services are being made available evenly throughout the country; the areas of greatest need in this regard at present; and if he will make a statement on the matter. [27127/22]
View answerWritten answers
In 2021, the HSE commenced a new procurement that allows patients to have treatment with private Specialist Orthodontists. The Waiting list plan initiative for 2022 included €11 million in funding is to be made available for identified community initiatives, including a focus on orthodontics. A HSE orthodontic treatment waiting list initiative in 2022 will see Children and Young People assessed as Grade 4 who have been waiting over 4 years for treatment at a cost of €2.8m. As of the 9th of May, 464 children and young people have been taken off the orthodontics waiting list using private providers under this new procurement framework. It is anticipated that the orthodontics waiting list initiative will continue to the end of the year.
As part of the question is a service matter I have asked the HSE to reply directly to the Deputy as soon as possible.
Disease Management
Questions (380)
Bernard Durkan
Question:380. Deputy Bernard J. Durkan asked the Minister for Health the extent to which adequate provision is being made to ensure the availability of early intervention for patients with scoliosis or spina bifida; and if he will make a statement on the matter. [27128/22]
View answerWritten answers
I sincerely regret that children can experience a long waiting time for orthopaedic treatment, and I remain conscious of the burden that this places on them and their families. One of the central priorities for me as Minister for Health is that waiting times for hospital appointments and procedures are improved, and that children receive the care that they need and deserve in a timely and appropriate fashion. In particular, a special area of focus for me and my Department is that of paediatric orthopaedics.
In January I asked the HSE to develop a dedicated plan to tackle scoliosis waiting lists this year. In February I met with senior officials of Children’s Heath Ireland (CHI) and the HSE, as well as senior orthopaedic clinicians from Temple Street, Crumlin and Cappagh, to discuss the finalisation of the proposals to increase orthopaedic activity at CHI. The plan proposes ambitious additional activity levels which will work to reduce the number of children waiting for spinal orthopaedic procedures (scoliosis and spina bifida) by year end.
This latest initiative is further evidence of this Government’s commitment to address the issues facing these children. Both current and capital funding has been provided to a value of €19 million in 2022 to support this initiative.
More specifically, €3.4 million has been committed to support additional activity at Cappagh Orthopaedic hospital. This is the full year requirement associated with the €1.65 million that was provided from the Access to Care Fund in 2021 to support CHI paediatric orthopaedic activity at Cappagh. Furthermore, €4.7 million has been provided on a recurring basis since 2021 to fund an additional 24 beds at Crumlin and Temple street, and 2 high dependency unit beds at Crumlin. These beds will facilitate the increase in activity needed to reduce paediatric orthopaedic waiting times. A further €4 million has been committed for a theatre expansion programme across CHI sites to focus on paediatric orthopaedics. Capital funding of €4 million has been designated to support this initiative, which is included within the 2022 Capital Plan. Finally, €2 million has been provided for outsourcing initiatives for both inpatient and daycase procedures, as well as to meet radiology needs. Plans are currently being finalised by CHI in this regard.
Medicinal Products
Questions (381)
Bernard Durkan
Question:381. Deputy Bernard J. Durkan asked the Minister for Health the extent to which rare and orphan medicines continue to be tested and make available here; the extent to which progress is slow on any particular medicine; and if he will make a statement on the matter. [27129/22]
View answerWritten answers
The Health (Pricing and Supply of Medical Goods) Act 2013 gives full statutory powers to the HSE to assess and make decisions on the reimbursement of all medicines taking account of a range of objective factors, clinical benefits, cost effectiveness and expert opinion as appropriate.
Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority.
The Committee for Orphan Medicinal Products (COMP) is the EMA's committee responsible for recommending orphan designation of medicines for rare diseases. This designation is for medicines developed for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious. The European Commission decides whether to grant an orphan designation for the medicine based on the COMP's opinion. The application process for this designation takes a maximum of 90 days from validation.
In the EU, medicines for rare diseases must be authorised by the European Commission under the ‘centralised procedure’. It is therefore not open to Irish authorities to grant a marketing authorisation for orphan medicines outside of this framework. Evaluating a marketing-authorisation application under the centralised procedure can take up to 210 days, not counting clock stops when applicants have to provide additional information. It is possible for an orphan medicine sponsor to submit an application through an accelerated assessment procedure. This procedure reduces the timeframe for the EMA to review the marketing-authorisation application to 150 days, not including any clock stops. It will then be up to the sponsor company to respond promptly to requests for additional information or data to support its application to avoid extended clock stops.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).
The HSE Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The role of the Drugs Group is to make a recommendation to the HSE Executive Management Team (EMT) in relation to each individual application having considered the criteria under the 2013 Act.
As the decision-making authority within the HSE, the HSE EMT decides on the basis of all the demands with which it is faced (across all services) whether it can fund a new medicine, or new uses of an existing medicine, from the resources that have been provided to it in line with the 2013 Act.
The 2013 Health Act does not include provision for a different ruleset when assessing orphan medicines. However, the criteria that apply to the evaluation process allow the HSE to have particular regard for the unique circumstances surrounding orphan drugs, such as small patient populations and unmet clinical need.
The pipeline of new medicines coming to market remains strong and this government wants to secure fast access to medicines for the most vulnerable of our patients, including those for the treatment of rare diseases. The principal factors determining the speed of reimbursement are the price at which a manufacturer applies for the reimbursement of a product, the availability of Exchequer funding, and the outcome of the HSE’s rigorous assessment process as to its clinical and cost-effectiveness.
Budget 2021 allocated €50 million for the approval of new drugs and 19 of the 52 new medicines approved by the HSE in 2021 were orphan medicines, representing over one third of approvals.
The budget allocation of €30m funding for new medicines in Budget 2022 will provide for the reimbursement of both orphan and non-orphan new medicines this year.
The HSE does not maintain a register of which medicines are designated orphan drugs, as the orphan status for a drug is subject to change at European level. However, the HSE anticipates that a number of medicines with orphan status are likely to be approved throughout 2022.
Medical Aids and Appliances
Questions (382)
Bernard Durkan
Question:382. Deputy Bernard J. Durkan asked the Minister for Health the extent to which his attention has been drawn to the difficulties affecting the availability of medical devices throughout the country; if measures are in hand to resolve any issues; and if he will make a statement on the matter. [27130/22]
View answerWritten answers
Regulation (EU) 2017/745 on medical devices (MDR) has been fully applicable as of 26 May 2021 and Regulation (EU) 2017/746 on in vitro Diagnostic Medical Devices (IVDR) becomes fully applicable as of 26 May 2022. The aim of these new regulations is to provide a robust and consistent regulatory framework for medical devices and enhance public health across the EU, by ensuring that medical devices are safe, perform as intended and afford benefits to patients and healthcare systems.
One of the challenges in implementing these new regulations, relates to the capacity of notified bodies certifying devices under the new regulatory framework, which has indeed been compounded by the Covid-19 pandemic. My department is working closely with the Health Products Regulatory Authority (HPRA) and the EU in considering and addressing this important matter as a priority. It is important to reiterate that full and effective implementation of the new regulatory framework remains a key priority for my department.
To address the specific query regarding difficulties affecting the availability of medical devices, I can confirm that the HPRA has not been informed of specific device shortages in Ireland. The HPRA does encourage medical devices stakeholders, including economic operators, healthcare institutions and healthcare professionals to raise any specific medical device shortages that may relate to Notified Body capacity issues directly with them.
Medical Aids and Appliances
Questions (383)
Bernard Durkan
Question:383. Deputy Bernard J. Durkan asked the Minister for Health if it is intended to add any issues relating the availability of medical devices to the agenda of the next European Union Health Council Meeting that is due to take place on 17 June 2022; and if he will make a statement on the matter. [27131/22]
View answerWritten answers
The next meeting of the Employment, Social Policy, Health and Consumer Affairs Council (Health) is due to take place in Luxembourg on 14 June 2022. I understand the draft agenda will include an item relating to the implementation of the Medical Devices Regulation.