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The following is issued on behalf of the Hospital Authority:
The spokesperson for Queen Elizabeth Hospital (QEH) today (September 12) announced the findings of the investigation reports regarding an earlier announced incident on the use of expired surgical sutures on patients.
On July 3, 2014, a report was made to the Cardiothoracic Surgery Department that between July and December 2013, expired surgical sutures (proper name: polyester sutures) with an expiry date in June 2013 had been used on patients who had undergone heart surgery. The usual shelf life of these surgical sutures is five years. The package was vacuum sealed and sterilised.
The hospital was deeply concerned about this incident and set up a Root Cause Analysis Panel and a Clinical Review Panel for investigation (membership lists of the two panels are appended). After thorough investigation, the Root Cause Analysis Panel found that the incident was due to over-procurement of a batch of specialty-based sutures. These expired sutures were subsequently used by nursing staff against the usual nursing standards in perioperative care. The existence of different lines of reporting in the operating theatre and the lack of monitoring by personnel involved in the procurement of the medical consumables concerned also contributed to the occurrence of the incident.
After a thorough review on the affected patient cases by both panels, it was confirmed that the number of affected patients should be 104 instead of 239 as announced earlier on July 5. The patient figures announced earlier were based on preliminary assessment, and were rectified after the hospital arranged more thorough checking on each patient's medical records. Among these 104 patients, 13 had passed away due to their own medical illnesses.
In the process of investigation, the Clinical Review Panel obtained similar sutures which had been expired for six months from the supplier for testing. The test results on the expired sutures kept in vacuum-sealed packaging on bacteria culture and quality were unremarkable. The Clinical Review Panel also thoroughly reviewed the clinical records of the 13 death cases and concluded that their causes of death were not related to the use of expired sutures.
Based on the above findings, the Root Cause Analysis Panel made the following recommendations:
1. The hospital should enhance the supervision and monitoring of the procurement and inventory control process with strengthening of the expiry alert mechanism, particularly for medical consumables that are not included in the Inventory Control System, e.g. slow-moving and specialty-use surgical sutures.
2. The hospital management should review the governance of specialty-based perioperative teams in order to enhance the administrative and managerial functions, and to align the authority and responsibilities of the supervisory personnel.
3. A speak-up culture should be cultivated among health-care workers, and staff consultation opportunities should be available and made known to the front line.
The QEH Hospital Chief Executive, Dr Albert Lo, said the two reports have been submitted to the Hospital Authority Head Office, while the hospital has accepted and implemented the panel recommendations. On behalf of QEH, Dr Lo apologised to all affected patients and relatives once again. The hospital is contacting the affected patients to explain the details and appropriate tests will be arranged.
Dr Lo remarked that the hospital will follow up in accordance with established human resources procedures. He also expressed gratitude to the Chairmen and Members of the two panels for their endeavours and efforts.
Ends/Friday, September 12, 2014
Issued at HKT 18:34
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