Ankara’s Kuzeykent Private Hospital Group has suspended some planned operations after a health audit found that two sterilising machines failed to reach required temperatures for months, while their sensors reported successful cycles. The problem came to light after rainwater entered a processing room on 6 September and a trolley carrying sealed instrument packs tipped during the response.
No one was injured, and the hospital says it has found no infection linked to the equipment. But auditors say instruments processed by the two machines were used in 1,760 procedures between April and September, exposing patients to a risk that neither staff nor patients were told about at the time.
The Central Anatolia Health Directorate’s audit, released on Thursday, found that test runs reached only 116°C to 119°C (241°F to 246°F), instead of the required 134°C (273°F) cycle. The machines’ displays nevertheless recorded compliant temperatures. Inspectors said they could not confirm that every set processed was unsafe, but the faulty readings made the cycle records unreliable.
How the fault came to light
The discovery followed a short, heavy shower that sent water through a ceiling joint in the hospital’s instrument-processing unit. A technician moved sealed packs away from the leak; when the trolley tipped, packs touched the wet floor and were discarded. The hospital’s incident report prompted a check of the sterilising room and then a wider review of machine performance.
Inspectors later tested all five steam sterilising machines at the site. Two repeatedly fell short, the audit says, while three passed. It also found the group had paid 6.8 million lira (about €180,000) for servicing visits without obtaining signed calibration certificates for ten of the visits listed in its accounts.
Peter Malá, deputy chief of the directorate’s device-safety unit, said the accident had “made a routine failure impossible to ignore”. He said the group must contact patients whose procedures used instruments from the two machines, offer clinical checks where appropriate and retain records for a 90-day follow-up. The regulator is considering a fine of up to 42 million lira (about €1.1 million).
Patients await answers
The hospital group has paused planned procedures that rely on instruments processed at the affected site, while emergency care continues. David Maras, its quality director, said the hospital was reviewing every operation in the audit period and had hired an outside engineering firm to test the machines. “We regret that our records gave staff confidence they should not have had,” he said.
Ove Ladefoged-Bjerg, who had a planned procedure at the hospital in May, said he received a call from the group on Wednesday and was offered an appointment. “I want to know what was used and whether I need any checks, not a general assurance that everything is fine,” he said. The directorate has not reported any confirmed infection tied to the machines.
Júlia Adamcová, an infection-control physician at the fictional Ankara Centre for Clinical Safety, said a low-temperature cycle does not prove that an instrument carried an infection, but it prevents hospitals from relying on the usual sterilisation guarantee. She said the regulator should check whether other sites in the group use the same maintenance provider and sensor model.
The directorate said it will inspect 14 private hospitals across Central Anatolia by 30 September, focusing on calibration records and physical temperature tests rather than display readings alone. Kuzeykent said it would cooperate and publish the results of its patient reviews. The hospital has not said when routine operations at the affected site will resume.
