Written Answers Nos. 836-859
836. Deputy David Cullinane asked the Minister for Health the number of cardiac patients seen or treated in the mobile catheterisation laboratory at University Hospital, Waterford since it became operational, by week; and if he will make a statement on the matter. [46912/17]
View answerIn relation to the specific case raised, I have asked the HSE to respond to you directly.
837. Deputy David Cullinane asked the Minister for Health the length of time the mobile catheterisation laboratory will remain operational at University Hospital Waterford; the estimated operational and capital cost; the type of work undertaken in the laboratory; and if he will make a statement on the matter. [46913/17]
View answerThe Mobile Cath Lab was deployed for the short term provision of cardiac diagnostic angiogram services on the grounds of University Hospital Waterford from 2 October 2017 for a period of 20 weeks i.e. until end of week commencing 12 February 2018. The Mobile Cath Lab is providing a scheduled diagnostic angiography service on a 3 day per week basis. The estimated cost of the temporary additional service is €800,000 for the 20 weeks.
839. Deputy Róisín Shortall asked the Minister for Health the reason for the slow pace of recruitment for three positions for a project (details supplied) in Dublin 11; the steps that will be taken to expedite this process in order to ensure this vital community project is initiated; and if he will make a statement on the matter. [46945/17]
View answerAs this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.
840. Deputy Thomas P. Broughan asked the Minister for Health the position regarding Ireland's bid to host the European Medicines Agency; and if he will make a statement on the matter. [46959/17]
View answerAs the Deputy will be aware, an Interdepartmental/Interagency Group, chaired by my Department, was established to prepare a bid for the relocation of the European Medicines Agency (EMA) to Dublin. The offer, which can be viewed on www.emadublin.ie, was submitted to the European Council on 31 July 2017. Since then, an extensive political and diplomatic campaign in support of the offer has been undertaken. A decision will be made on the relocation of the EMA at the General Affairs Council on 20 November 2017.
841. Deputy Róisín Shortall asked the Minister for Health the proposed implementation programme office for Sláintecare; the reason for the delay in the recruitment of a person to head up this office; and the timeframe to which he is now working. [46969/17]
View answerAs the Deputy is aware, I supported the establishment of the cross-party Committee on the Future of Healthcare and have consistently supported its work. I have welcomed the publication of the Sláintecare report and in particular I have been encouraged by the level of cross party consensus and stakeholder support that it has attracted.
I am committed to making tangible and sustainable improvements in our health services and the Committee’s work now provides a framework to do this. I have briefed Government colleagues on the report and I have received approval to move ahead with the establishment of a Sláintecare programme office. This office will be tasked with implementing a programme of reform, as agreed by Government, arising from the Sláintecare Report. It will be led by a senior executive with the appropriate experience and skillset including a strong track record in implementing reform. My Department and the Department of Public Expenditure and Reform have sought to ensure that we are positioned to attract candidates of the required calibre for what will be a significant reform process. It is essential, therefore, that we get this recruitment process right. I expect the recruitment to be advertised very shortly.
In parallel, work is underway to develop a detailed response to the report. The report is wide reaching and it is important that appropriate time is allowed for it to be fully considered and for implementation arrangements to be properly designed. I will report back to Government in December on the work we are doing to translate the Sláintecare Report into a programme of action. I will also be briefing the Joint Committee on Healthcare on progress on 22 November 2017.
842. Deputy Róisín Shortall asked the Minister for Health further to his proposals to carry out an impact assessment of the separation of public and private work in public hospitals in line with the Sláintecare report; the persons that will work with a person (details supplied); the terms of reference which will apply to this group; and the timeframe which he proposes for their work. [46970/17]
View answerOn the 13 October 2017 I announced the establishment of an independent group which will examine the impact of separating private practice from the public hospital system. The parameters of this group's work, and the group's membership, are currently under consideration in my Department. I hope to be in a position to make an announcement about the group in the near future.
843. Deputy Billy Kelleher asked the Minister for Health if the HSE will arrange for the recipients of Respreeza to receive their infusions in the same manner as they have always received them following the withdrawal of a company (details supplied) from covering the cost of this; and if he will make a statement on the matter. [46971/17]
View answerThe HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013; therefore, the matter has been referred to the HSE for reply to the Deputy.
845. Deputy Louise O'Reilly asked the Minister for Health the procedure when a device is reported to the Health Products Regulatory Authority, HPRA; if the HPRA has the power to have a medical device removed from the Irish market; if not, the reason therefor; his views on whether this is putting persons at risk; and if he will make a statement on the matter. [46976/17]
View answerThe Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines and medical devices in Ireland. Its role is to monitor the safety of medical devices and to ensure the manufacturer takes any necessary measures relating to their devices so they can be used safely without posing unnecessary risk to patient or user health. The HPRA has the powers to take all appropriate measures to withdraw devices from the market or prohibit or restrict their being placed on the market or put into service. Under S.I. No. 444/2001 - European Communities (Medical Devices) (Amendment) Regulations, 2001, where the ‘Competent Authority considers that, in order to ensure protection of health and safety or to ensure that public health requirements are observed in accordance with Article 36 of the Treaty of Rome, the availability of any device should be prohibited, restricted or subjected to any particular requirements, it may give a temporary direction to that effect’.
846. Deputy Louise O'Reilly asked the Minister for Health if there is a database log of complications experienced by women that have been fitted with a transvaginal mesh device; if not, the reason there for; and if he will make a statement on the matter. [46977/17]
View answerThe Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines and medical devices in Ireland.
The HPRA does not routinely collect or maintain information on the number of women in Ireland who have received transvaginal mesh devices or vaginal mesh implants as the HPRA does not have a direct role in approving, licensing or certifying medical devices that are placed on the market in Ireland. They have a post market role where they monitor the medical devices on the market. As the Deputy was previously advised, to date, the HPRA identified two unconfirmed reported incidents in respect of transvaginal mesh devices and vaginal mesh implants.
The HPRA strongly encourages those who have experienced a safety issue with a medical device, including transvaginal mesh devices or implants, to report it through its medical device adverse incident reporting system. The system is accessible to patients, healthcare professionals or any person who identifies a medical device safety issue. Issues or concerns about a medical device can be submitted through the HPRA website’s online reporting system or by downloading and completing an incident report form which is also available from its website, www.hpra.ie
847. Deputy Louise O'Reilly asked the Minister for Health if transvaginal mesh devices underwent testing before coming onto the market here; the details and results respectively of the testing; and if he will make a statement on the matter. [46978/17]
View answerAll medical devices, including transvaginal mesh devices, are certified (CE marked) at European level prior to being placed on the market. For mesh devices as class IIb medical devices the products are certified by independent certification organisations, called notified bodies, who are required to have the necessary expertise to assess different types of device technologies. This EU-level assessment demonstrates that the devices comply with the Essential Requirements of the medical device legislation, including those relating to performance and safety. This certification is based on assessment of relevant testing, technical, pre-clinical and clinical data to demonstrate the technical characteristics and the clinical safety and performance of the device.
The Health Products Regulatory Authority (HPRA) is the competent authority for medical devices in Ireland. In accordance with the EU legislation it does not approve medical devices prior to their being placed on the Irish market, rather it has a post market surveillance role where they monitor the medical devices on the market. The approval of medical devices prior to their being placed on the market is carried out at European level by notified bodies. The HPRA does not have access to the specific details and results of testing conducted on individual devices as this information would normally be held by the EU notified body who certifies the device.
848. Deputy Louise O'Reilly asked the Minister for Health if he will request the HSE and private surgeons that have implanted transvaginal mesh devices to write to the women involved outlining the possible complications or side effects which are associated with such implants in order that their attention is drawn to issues and they are informed in this regard, in view of the fact that many side effects do not occur until many years later; and if he will make a statement on the matter. [46979/17]
View answerThe Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines and medical devices in Ireland.
The HPRA does not routinely collect or maintain information on the number of women in Ireland who have received transvaginal mesh devices or vaginal mesh implants as the HPRA does not have a direct role in approving, licensing or certifying medical devices that are placed on the market in Ireland. They have a post market role where they monitor the medical devices on the market.
The HPRA strongly encourages those who have experienced a safety issue with a medical device, including transvaginal mesh devices or implants, to report it through its medical device adverse incident reporting system. The system is accessible to patients, healthcare professionals or any person who identifies a medical device safety issue. Issues or concerns about a medical device can be submitted through the HPRA website’s online reporting system or by downloading and completing an incident report form which is also available from its website, www.hpra.ie .
It is important to note that these devices continue to be certified as compliant with relevant EU legislation and have not been subject to specific recall.
The use of transvaginal mesh in a procedure is a clinical decision made by the consultant with the patient, at which point possible complications would be brought to the patients attention
850. Deputy Louise O'Reilly asked the Minister for Health if general practitioners will received additional training to identify mesh related complications; and if he will make a statement on the matter. [46981/17]
View answerAll doctors on the Medical Council's register, including GPs, are required to maintain professional competence by enrolling in professional competence schemes and engaging in maintenance of professional competence activities in relation to their practice. In this context, the Council has established a range of professional competence schemes through formal arrangements with the recognised postgraduate training bodies. Schemes are operated by the postgraduate training bodies and have been developed to drive good professional practice, which is centered on patient safety and quality of patient care.
The Irish College of General Practitioners (ICGP) is the recognised professional body for general practice and is responsible for post graduate specialist medical education, training and research in the specialty of general practice.
The ICGP Women’s Health Programme provides educational programmes for GPs in the area of women’s health, including gynaecology, and delivers this via e-learning; the ICGP journal Forum; circulars to GPs; courses and national conferences. The Women's Health Programme regularly reviews its educational programmes and adapts content based on identified needs and evidence based medicine. Content currently includes education for GPs on the presentation, management and referral of gynaecological problems as well as follow up and identification of complications post gynaecological surgery.
853. Deputy Marcella Corcoran Kennedy asked the Minister for Health his plans to include Kabuki syndrome on the list of disabilities which will allow access to the range of services and supports provided by the HSE; and if he will make a statement on the matter. [46987/17]
View answerThe Government is committed to providing services and supports for people with disabilities which will empower them to live independent lives, provide greater independence in accessing the services they choose, and enhance their ability to tailor the supports required to meet their needs and plan their lives. This commitment is outlined in the Programme for Partnership Government, which is guided by two principles: equality of opportunity and improving the quality of life for people with disabilities.
The particular issue raised by the Deputy is a service matter for the HSE. Accordingly I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy.
854. Deputy Michael Healy-Rae asked the Minister for Health the status of an appointment in university hospital Kerry for a person (details supplied); and if he will make a statement on the matter. [46993/17]
View answerUnder the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.
The scheduling of appointments for patients is a matter for the hospital to which the patient has been referred. Should a patient's general practitioner consider that the patient's condition warrants an earlier appointment, he or she should take the matter up with the consultant and the hospital involved. In relation to the specific case raised, I have asked the HSE to respond to you directly.
856. Deputy Bernard J. Durkan asked the Minister for Health if an alternative general practitioner can be arranged in the case of persons (details supplied); and if he will make a statement on the matter. [47011/17]
View answerAs this question relates to a service matter, I have arranged for the question to be referred to the Health Service Executive for direct reply to the Deputy.
857. Deputy Bernard J. Durkan asked the Minister for Health if a home care package can be facilitated in the case of persons (details supplied); and if he will make a statement on the matter. [47012/17]
View answerAs this is a service matter I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
858. Deputy Louise O'Reilly asked the Minister for Health if vertebral body tethering for the treatment of scoliosis is available via the HSE; and if he will make a statement on the matter. [47016/17]
View answerIn relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to you directly.
859. Deputy Louise O'Reilly asked the Minister for Health if his attention has been drawn to persons who have accessed vertebral body tethering via the cross-border health directive; the dates for this treatment; the name of the physician recommending it here; and the follow-up care provided by the HSE. [47017/17]
View answerAs the Health Service Executive operates the EU Directive on Patients’ Rights in Cross Border Healthcare in Ireland it has been asked to examine this matter and to reply to the Deputy as soon as possible.
