Here are the key findings from a HIQA review into the use of unapproved springs in a series of spinal surgeries by one surgeon at Children's Health Ireland Temple Street.
The Health Information & Quality Authority (HIQA) has published a 200-page review into the use of unapproved implantable springs in spinal surgery at Temple Street Children's University Hospital in Dublin.
The springs were implanted into three children with scoliosis, with HIQA finding that there was no evidence of ethical approval at the hospital for their use by one surgeon, who is known in the report as Surgeon A.
Surgeon A described the use of the springs to HIQA as "bespoke and experimental" and the watchdog found there was a lack of detailed discussions with parents in line with consent practice.
HIQA made 19 recommendations, including a review of organisation-wide corporate and clinical governance at Children's Health Ireland.
Procurement
The review found that Surgeon A engaged with the then principal clinical engineering technician at CHI at Temple Street to purchase the non-CE-marked springs.
However, there was an absence of structures to support clear and adequate communication between them about the intended purpose of the springs.
Surgeon A sought to purchase the non-CE-marked springs after attending an expert international orthopaedic conference on early onset scoliosis in 2018, where a team of researchers from the Netherlands presented the initial findings of a new implantable "spring-distraction system" for the treatment of scoliosis.
"The research team from the Netherlands told HIQA that they were not contacted by Surgeon A at any time to discuss their research," the review noted.
HIQA also found that there were "no controls in place to carry out any type of safety and technical checks" prior to their use.
Governance
HIQA found that the revised corporate and clinical governance structures at Temple Street from January 2019 onwards "were not clear or easy to understand for all staff at either hospital-site or clinical directorate level".
This was the period when Temple Street was being integrated into CHI along with Our Lady's Children's Hospital, Crumlin, and the paediatric services of Tallaght University Hospital.
HIQA found that these governance arrangements were overly complex and placed "an onerous and unrealistic workload expectation" on clinical directors and senior managers.
"These arrangements did not lend themselves to clear lines of reporting and oversight of operations on a day-to-day basis at each of the hospital sites for the delivery of high-quality, safe care," the review said.
It added that these the impacts of these issues were exasperated at CHI Temple Street.
"Given the smaller number of clinical specialty services provided at CHI at Temple Street, changes to the governance arrangements meant that some structures, including some key members of existing senior management, moved off site.
"Prior ways of working were disrupted and the governance arrangements at the hospital for front-line staff delivering services at CHI at Temple Street became less clear under the new structures.
"HIQA found that these arrangements were complex and did not lend themselves to clear and accountable governance and may have affected the ability for those responsible for the service to effectively oversee the delivery of care."
The review also highlighted what it described as "cultural issues" within the orthopaedic department at CHI Temple Street, along with "sustained challenges" in providing paediatric spinal surgical services in a timely manner.
This, the review found, led to a situation where the unapproved springs were introduced because "important and relevant questions" were not raised at various steps in the procurement process.
It said that CHI Temple Street had no committee in place to approve and oversee the introduction of "class III medical devices".
These devices include implantable medical devices and, in this case, would have included consideration of the springs.
Surgical use
The review noted that the use of the springs were part of a "well-intentioned but ill-considered effort" to provide an alternative approach to surgical treatment for a number of children with life-limiting conditions, with one operation rather than multiple operations.
It found there were good decontamination procedures in place in at CHI Temple Street at the time, but there was "significant deviation from this policy in respect of the springs within the central decontamination unit at the hospital".
The springs also did not have individual unique identifiers applied to them before their use.
"This lack of a unique identifier being applied to each spring meant that each spring could not be tracked individually when scanned for use in theatre or when the remaining springs went through subsequent decontamination cycles," it said.
HIQA said that the use of these springs as surgical implants was wrong, and that CHI Temple Street’s governance arrangements became "increasingly complex and unwieldy".
"This had implications for ongoing clinical oversight of the spinal surgery services at CHI at Temple Street during the timeframe covered by this review.
"In particular, this is evident in the absence of the identification by CHI at Temple Street, of the further use of the non-CE marked springs in the surgery that was carried out in 2022."
The report concluded with HIQA acknowledging the impact this incident has had on the children and families using the orthopaedic spinal surgery service in CHI at Temple Street, particularly those who were directly impacted.
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