Steel springs implanted in children during spinal surgery were made from a metal known to corrode and were not evaluated due to gaps in hospital procedures, health regulator Hiqa has found.
Children were not protected from the risk of harm at Children’s Health Ireland (CHI) due to lack of adequate safeguards in many processes,the report, published on Tuesday, concluded.
Inspectors wanted to find out how and why springs made from non-alloyed spring steel instead of medical grade stainless steel were used in three children’s surgeries.
They interviewed a surgeon in CHI at Temple Street hospital, Professor Connor Green. They contacted manufacturing companies, a Dutch research team and various hospital staff.
The HSE requires all medical devices to have a CE mark, so staff know it is suitable and it knows how they plan to use it.
However lead inspector Seán Egan said Hiqa found “a lack of clear and adequate checking in relation to the order, procuring and use of the springs”.
The consultant, named only as Surgeon A in the report, had seen a Dutch research team present on use of springs to help treat scoliosis.
He was inspired by this as a way to offer a once-off operation rather than a series of operations. However, he did not contact the researchers directly, Hiqa found.
He ordered springs made from a metal different to that used in their studies. These springs were ordered from an industrial machinery company.
In a series of emails, the company said the springs were standard industrial steel and not designed to be covered by specific medical requirements.
The company also said it could not give details on how the springs might be properly decontaminated.
Hiqa said “these emails should have raised concerns with Surgeon A”.
Inspectors also identified a disconnect between the hospital decontamination manager, who felt it was the surgeon’s responsibility to check these details, and the surgeon who felt it was the manager’s.
The springs were used in spinal surgery along with the spinal rods usually used for this purpose.
The company which makes the rods told Hiqa it did not make springs.
The instruction manual says not to mix them with other metals.
In the report, Hiqa explains mixing metals “may also be potentially harmful to the patient”.
The surgeon told Hiqa no specific checks were carried out on whether these rods and springs could be used together.
The report concluded if the right oversight had been in place, these problems could have been identified earlier.
It also raised alarm over gaps in procedures across operating theatres.
It said, for example, there was no sign staff were briefed about the springs before the operations.
In fact, there were many “missed opportunities” to stop their use due to the lack of questioning and verification, Hiqa said.
The review also found no evidence the use of these springs was put before the hospital's ethics and research committee. It was not discussed with the medical device equipment management committee either.
Hiqa raised concerns about how often the latter committee met, and the scope of its duties.
Overall, Hiqa made 19 recommendations, nine for CHI, nine for the HSE and one for all providers, including private hospitals.
“It is essential that key lessons are learned from this review at both CHI, and in other health services nationally, particularly with respect to the governance of clinical innovation and practice,” Mr Egan said.
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