Ongoing replacement of non-CE-marked surgical instruments

A programme is ongoing at the National Orthopaedic Hospital Cappagh (NOHC) to replace non-CE-marked reusable surgical instruments. The issue was placed on its corporate risk register (CRR) in late 2024, according to records released under Freedom of Information law.

A hospital spokesperson told the Medical Independent (MI) the use of this instrumentation is fully compliant with current regulations. This issue does not relate to implantable medical devices which are all CE-marked, they stated.

A meeting of NOHC’s executive management team in November 2024 agreed that the following item would be entered onto the CRR: “There is a risk of harm to patients due to not all surgical instrumentation being CE-marked in line with MDR (EU) 2017/745.”

The hospital’s spokesperson told MI there was “no known risk” associated with these non-CE-marked surgical instruments. “This relates to legacy non-implantable instrumentation, which were purchased before MDR 2017/745 regulation came into effect.”

The instruments were purchased “in line with legislation in place at the time of purchase”, namely Directives 90/385 EEC and 93/42/EEC, which were enforced prior to MDR 2017/745.

The spokesperson noted that amendments have been made to the MDR 2017/745 to allow for a transition period for such devices purchased under previous regulations. “These amendments were made in recognition of an imminent shortfall and thus, public health risk, if such instrumentations were taken out of circulation.” The hospital anticipates that removing these items from theatre will become mandatory in 2028, and it is therefore “proactively removing them from use”.

“NOHC has policies and procedures (including risk assessments) in place to continuously monitor, maintain, and replace (within available budgets) all equipment and instrumentation to ensure that there is no risk to patients.”

They added: “These particular items have been on the hospital’s HSE NERP [national equipment replacement programme] application since before 2019, before MDR came into place as Class Ir regulation [relating to reusable surgical instruments] came into place in May of 2021.”

There had been no incidents relating to the instruments, the spokesperson said.  “All instrumentation used is checked by theatre staff before use.”