Spinal Surgery in Paediatric Care

Evidently spinal surgery is invasive, complicated surgery and in the context of paediatric care may be needed for a child with conditions such as spina bifida, scoliosis or a congenital spinal abnormality.

The purpose of the procedure is to improve qualify of life for the patient not disimprove.

Unauthorised spinal springs which is an implant in a pediatric care context raises significant concerns about patient safety, information consent and standard of care for patients, family members affected. There are wider public concern considerations also.

Issues arise if families are not notified these springs are being used. A child has a right to bodily integrity.

In Ireland, the use of surgical implants in patients is governed by the EU and Irish legislation. The EU Medical Device regulatory framework was first put in place in the 1990s. The current framework is the Medical Device Regulations (MDR), which became fully applicable in Ireland in May 2021. Prior to this, medical devices were covered by the General Medical Devices Directive (MDD).

CE Marking

EU CE markings purpose is in order for product certification ie a mark which is used to indicate a product’s compliance with the European Union’s (EU) health, safety, and environmental protection standards. “CE” is the acronym for Conformité Européenne, meaning “European Conformity.

If non CE marked springs are inserted during spinal surgery operations this evidently can be problematic or carry significant risk.

Legal Considerations

If inappropriate medical devices or springs were used during the course of a procedure without the knowledge of the patient and parents, this evidently can create an issue informed consent for the procedure. A patient is owed a duty of care by the healthcare provider, the standard of care must be appropriate and if unapproved medical devices or springs are used during a procedure without prior to disclosure this will cause significant concern for the parents.