Medical Aids and Appliances Provision

Ceisteanna (233)

Maurice Quinlivan

Ceist:

233. Deputy Maurice Quinlivan asked the Minister for Health the number of persons waiting for orthotic shoes, by county; the waiting time for same, by county, in tabular form; and if he will make a statement on the matter. [4852/18]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

As this is a service matter, it has been referred to the Health Service Executive for direct reply to the Deputy.

Medical Aids and Appliances Provision

Ceisteanna (234)

Maurice Quinlivan

Ceist:

234. Deputy Maurice Quinlivan asked the Minister for Health if his attention has been drawn to the fact that a person (details supplied) has been advised that the waiting list for orthotic shoes will be up to three years; and if he will make a statement on the matter. [4853/18]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

As this is a service matter, it has been referred to the Health Service Executive for direct reply to the Deputy.

Home Care Packages

Ceisteanna (235)

Maurice Quinlivan

Ceist:

235. Deputy Maurice Quinlivan asked the Minister for Health if his attention has been drawn to the fact that since 2014 due to a lack of funding there is no pain relief available for those receiving home care (details supplied); and if he will make a statement on the matter. [4854/18]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

As this is a service matter, I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.

Ministerial Advisers Data

Ceisteanna (236)

Shane Cassells

Ceist:

236. Deputy Shane Cassells asked the Minister for Health the names of advisers he has appointed to his office since becoming Minister; the responsibilities of each; the previous employment of each; the salaries of each; and if he plans to make further additional appointments. [4870/18]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

There have been two special advisers appointed to me as Minister for Health (Joanne Lonergan and Kathyann Barrett). The salary applicable to both advisers is the standard scale for the grade of Principal Officer in the Civil Service (€80,852 - €99,408) in accordance with the Department of Public Expenditure and Reform instructions to Personnel Officers on Ministerial Appointments for the 32nd Dáil. The special advisers are suitably qualified for their roles.

Hospital Facilities

Ceisteanna (237)

Clare Daly

Ceist:

237. Deputy Clare Daly asked the Minister for Health his plans to introduce translabial ultrasound facilities in public hospitals in order that issues with transvaginal mesh may be identified without women that are suffering severe side effects having to travel to the UK for such scans. [4880/18]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

As this is a service issue, I have asked the HSE to reply to you directly.

Medicinal Products Regulation

Ceisteanna (238)

Clare Daly

Ceist:

238. Deputy Clare Daly asked the Minister for Health his plans to review the licensing conditions used by the HPRA in regard to medical devices in view of the extremely severe side effects of transvaginal mesh, one brand of which (details supplied) was brought to market following a trial in only 31 women and in which the mesh failed in 30% of subjects. [4883/18]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

In accordance with Medical Devices Directive 93/42/EEC (as amended), the Health Products Regulatory Authority (HPRA) does not have a direct role in approving, licensing or certifying medical devices that are placed on the market in Ireland. The HPRA has a post market role where they monitor the medical devices on the market. As Minister for Health, I have no role in the approval, licensing and certification process for medical devices.

To place a medical device such as a vaginal mesh implant on the Irish or EU market, the manufacturer must be authorised to do so following an assessment conducted by a notified body for medical devices. There are currently just over fifty such notified bodies based in Europe (one in Ireland – NSAI) and the manufacturer can choose any designated notified body to which it can apply for assessment and the award of a CE mark. Following its assessment and once satisfied that the device meets the relevant requirements, the notified body will issue a certificate for the medical device. This entitles the manufacturer to affix a CE mark to the device and thereafter market the product throughout Europe. The HPRA has advised that, to their knowledge, the NSAI has not certified a transvaginal mesh device at any time.

No regulatory action has been taken to date by Competent Authorities in any European country in respect of these devices. The Health Products Regulatory Authority (HPRA) advises that they are not aware of scientific evidence which concludes these devices are unsafe when used in line with their intended use. The HPRA continues to liaise closely with European Competent Authorities, the European Commission and with International regulatory agencies in relation to the international evidence relating to these devices.

As Minister for Health, I want to ensure that both the current use of mesh implants in urogynaecological procedures in Ireland, and the on-going clinical management of women who have had these procedures in the past, are in line with international best practice and emerging evidence.

At my request, the Chief Medical Officer is preparing a report on the many clinical and technical issues involved, including the issues raised by the Deputy.

This work involves engagement with national and international bodies, the professional colleges and others. This work is underway and will take a number of months to complete.

The Department strongly advises that any woman who experiences or suspects that she has experienced a complication associated with TVMI surgery should discuss this with her GP or with the hospital from which she received the implant. The Department also advises that women considering surgery involving TVMIs should thoroughly discuss with their doctors the indications, alternatives (surgical and non-surgical), benefits and risks involved in their personal circumstances.

Medical Aids and Appliances Provision

Ceisteanna (239)

Brendan Smith

Ceist:

239. Deputy Brendan Smith asked the Minister for Health if additional services will be provided at a hospital (details supplied); and if he will make a statement on the matter. [4910/18]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

The Smaller Hospitals Framework defines the role of smaller hospitals and outlines the need for smaller hospitals and larger hospitals to operate as Hospital Groups. The Framework identifies the activities that can be performed in smaller hospitals in a safe and sustainable manner. These include extended day surgery, selected acute medicine, a local injuries service, a large range of diagnostic services, specialist rehabilitation medicine and palliative care. In developing our smaller hospitals, as set out in the Smaller Hospitals Framework, the first and over-riding concern is the safety of patients.

Significant progress has been made in the establishment and development of Hospital Groups over the last few years. Our hospitals are now working together and supporting each other in Groups. This new way of working provides a stronger role for smaller hospitals, like Monaghan Hospital, in delivering less complex care. It also ensures that patients who require true emergency or complex planned care are managed safely in larger hospitals.

In relation to the specific query raised by the Deputy, as this is a service matter, I have asked the Health Service Executive to respond to you directly.