Tuesday, 5 February 2019

Questions (435)

Clare Daly


435. Deputy Clare Daly asked the Minister for Health if the Health Products Regulatory Authority's equivalent of black box warnings apply to morcellators sold here. [5542/19]

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Written answers (Question to Health)

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. The risk classification of a device influences the level of specific assessment of a medical device’s conformity with the legal requirements that is conducted and in the case of morcellators, a manufacturer must have the conformity to the requirements verified by a third party, namely a notified body for medical devices.

Once the notified body has satisfactorily completed its assessment it issues a certificate to the manufacturer who can then label their device with a CE mark. Medical devices which are appropriately CE marked may be freely placed on the European market. A notified body, once appropriately competent, in any European country can issue a certificate which allows the manufacturer to place the device on the market without further national authorisation.

Officials in my Department have queried this matter with the Health Products Regulatory Authority (HPRA), who understand that the black box warning referenced to in this question relates to a FDA warning issued in April 2014 that discouraged the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids and advised that such use poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus. Subsequently, following a public Advisory Committee meeting, the FDA also recommended that manufacturers of laparoscopic powered morcellators with a general indication or a specific gynaecologic indication prominently include a number of contraindications and a boxed warning in their product labelling.

In May 2014 the HPRA (then the Irish Medicines Board) wrote to Consultant Obstetricians and Gynaecologists via their professional associations (Royal College of Physicians in Ireland and Royal College of Surgeons in Ireland) highlighting the April 2014 FDA communication and requesting feedback on the information outlined in the FDA communication. The HPRA also coordinated with the European Commission and other European Competent Authorities to issue a letter to all medical device notified bodies in Europe highlighting that the FDA had requested that manufacturers of these products include contraindications and warnings on their product instructions and labelling. Notified bodies were requested to consider this potential risk in their review of manufacturers’ technical documentation and any updated product information, including labelling and instructions for use. Please note that within the context of the HPRA's role as designating authority for the National Standards Authority of Ireland (NSAI), HPRA communicated this issue to NSAI in November 2015.