The Hospital Authority (HA) today said it is proactively following up with medical device supplier Abbott Laboratories about the product recall of a prostate-specific antigen (PSA) reagent.
Two affected batches of the reagent were delivered to Caritas Medical Centre (CMC) and Tuen Mun Hospital (TMH) respectively.
CMC started to use the affected batch of reagent to test 406 patient blood samples since April 28, while the reagent delivered to TMH has not been used yet.
On May 27, the HA received notification from the supplier about complaints received in different places, revealing quality issues with certain batches of a PSA reagent.
These issues have led to deviations in test results, with some readings exhibiting a positive bias greater than 10%, which could potentially lead to a misdiagnosis of prostate cancer, causing doctors to erroneously consider unnecessary treatments.
For prudence sake, CMC has reviewed the test results of the 406 affected patient blood samples. It will contact approximately 70 patients this week and rearrange blood tests based on the patients’ clinical needs.
The remaining patients have also been scheduled for follow-up appointments in the coming weeks, during which doctors will explain the event and arrange appropriate management to ensure their treatment unaffected.
The HA said a PSA test is not a standalone diagnostic indicator and doctors will make a comprehensive clinical judgment based on patient’s clinical condition and other examinations to diagnose whether the patient has prostate cancer.
It also pointed out that the CMC has confirmed that no patients have undergone unnecessary clinical procedures nor experienced delays in treatment.
CMC has set up a hotline, 5334 0388 for patient enquiries.
As the reagent delivered to TMH has not yet been put into use, no patients have been affected.
Both CMC and TMH have stopped using the affected batches of reagent and replaced them with alternatives. The HA has also reviewed the reagent used in other public hospitals and confirmed that none have used the affected batches.
The PSA testing service in all public hospitals remains unaffected.
The HA is stringently following up on this event and has notified the Department of Health (DH).
The HA has demanded the supplier concerned to thoroughly investigate its quality control and testing records, provide an explanation, and implement remedial measures.
The authority also does not rule out taking further action to hold the supplier accountable, and will continue to closely follow up with the DH and the supplier.
The supplier will be required to provide quality control records and testing certifications in the future to prove that their testing supplies meet with the stringent requirements, so as to ascertain patient safety and testing accuracy.