Written Answers Nos. 1494-1500
1494. Deputy David Cullinane asked the Minister for Health the number of notifications that have been made by parents to the Health Products Regulatory Authority with regard to defective devices to date; and if he will make a statement on the matter. [19846/22]
View answerWithin the medical device framework, the Heath Products Regulatory Authority (HPRA) does not approve or certify medical devices for sale in Ireland or any other country. Medical devices placed on the Irish or European market must conform to the requirements of the relevant European legislation. These require that medical devices perform safely while achieving the purpose intended by the medical device manufacturer. In its role as market surveillance authority, the HPRA monitors the safety of medical devices after they are placed on the Irish market.
The aim of the medical devices vigilance system is to reduce the risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market. Within this context, the HPRA evaluates serious incidents and field safety corrective actions associated with medical devices. With respect to incident reporting, please note that while there is no mandatory reporting requirement for users, patients, care-givers and healthcare professionals, the HPRA strongly encourages all relevant stakeholders, including those already listed, to report any safety issues they have experienced with a medical device. Manufacturers are required to submit medical device serious incident reports to the HPRA within specified reporting timelines outlined in the legislation.
The HPRA has an ongoing market surveillance review related to the safety and performance of the MAGEC Spinal System, elements of which have been carried out in conjunction with the UK MHRA. As part of the review, the HPRA has carried out an assessment of the technical documentation related to the device. Implantation of MAGEC rods remains on hold in Ireland since April 2020 following issuance of a manufacturer field safety notice by the manufacturer, NuVasive Specialized Orthopaedics (NSO). HPRA continues to assess information provided by the manufacturer and other stakeholders in relation to suspected adverse events and risk assessment reports, among other documentation, to determine whether the benefits of using these devices outweigh the known and potential risks. As part of this ongoing review, the HPRA has liaised with relevant stakeholders including healthcare professionals who use this device and a patient advocacy group.
The HPRA has confirmed to the Department that to date the Authority has received fewer than five user reports from patients/care-givers regarding the MAGEC Spinal System. To preserve patient confidentiality, the HPRA does not specify the number of patients where the number of reports is fewer than five.
1495. Deputy David Cullinane asked the Minister for Health if titanium and cobalt blood serum tests are offered to all children who have magic rods implanted; and if he will make a statement on the matter. [19847/22]
View answerAs this is an operational matter, the question has been referred to the Health Service Executive for their attention and direct reply to the Deputy
1496. Deputy David Cullinane asked the Minister for Health the number of children who currently have magic rods implanted in Ireland; and if he will make a statement on the matter. [19848/22]
View answerAs this is an operational matter, the question has been referred to the Health Service Executive for their attention and direct reply to the Deputy
1497. Deputy David Cullinane asked the Minister for Health if he will outline the plans in relation to the way that the allocated €19 million will be spent to ensure all children in Ireland will have timely access to scoliosis care; and if he will make a statement on the matter. [19849/22]
View answerI 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 early 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 due to be approved shortly. 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.
Further details of the breakdown of these funds are provided for the Deputy in the attached document. Some of these figures are initial estimates and as such are subject to final review, agreement and potential revision on receipt of the detailed operational plan for delivery of this important initiative.
1498. Deputy David Cullinane asked the Minister for Health the number of children who are currently waiting for scoliosis surgeries in all categories, in tabular form; and if he will make a statement on the matter. [19850/22]
View answerIn February of this year 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 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.
In relation to the details requested by the Deputy, I have referred your question to the HSE and asked them to provide you with a direct response.
1499. Deputy David Cullinane asked the Minister for Health the number of children who are currently waiting on their first appointment with an orthopaedic consultant in Children’s Health Ireland, Crumlin and Cappagh Hospital; the length of wait, in tabular form; and if he will make a statement on the matter. [19851/22]
View answerThe information requested by the Deputy is published monthly by the National Treatment Purchase Fund (NTPF) on their website. The NTPF provides a breakdown of the Outpatient waiting list by specialty for each hospital, showing the figures for adults and children separately.
The waiting list reports can be accessed at: www.ntpf.ie/home/nwld.htm
1500. Deputy David Cullinane asked the Minister for Health the number of children who are currently waiting for an outpatient appointment with an orthopaedic consultant in HSE hospitals outside of Dublin; the length of time that they have been waiting, in tabular form; and if he will make a statement on the matter. [19852/22]
View answerThe information requested by the Deputy is published monthly by the National Treatment Purchase Fund (NTPF) on their website. The NTPF provides a breakdown of the Outpatient waiting list by specialty for each hospital, showing the figures for adults and children separately.
The waiting list reports can be accessed at: www.ntpf.ie/home/nwld.htm
