Hospital Authority proactively follows up with supplier on prostate specific antigen reagent product recall
The following is issued on behalf of the Hospital Authority:
The Hospital Authority (HA) spokesperson made the following announcement today (June 3) regarding a product recall of a prostate-specific antigen (PSA) reagent by medical device supplier:
The HA is proactively following up with medical device supplier Abbott Laboratories Limited on a PSA reagent product recall event. 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 positive bias greater than 10 per cent, which could potentially lead to a misdiagnosis of prostate cancer, causing doctors to erroneously consider unnecessary treatments.
The HA attaches great importance to the event. Upon receiving notification from the supplier, a thorough review was conducted across public hospitals, confirming two affected batches of reagent (Alinity i Total PSA Reagent Kit - Lot Numbers: 71210FZ00 and 71213FZ00) were delivered to Caritas Medical Centre (CMC) and Tuen Mun Hospital (TMH) respectively.
The CMC has started to use the affected batch of reagent to test 406 patient blood samples since April 28. For prudence's sake, CMC has reviewed the test results and will contact approximately 70 patients this week, based on their clinical needs to rearrange blood tests. 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 spokesperson stated, "A PSA test is not a standalone diagnostic indicator. Doctors will make a comprehensive clinical judgment based on patient's clinical condition and other examinations, such as a rectal examination, an ultrasound scan and a biopsy examination to diagnose whether the patient has prostate cancer. The CMC has confirmed that no patients have undergone unnecessary clinical procedures nor experienced delays in treatment due to the event. CMC has set up a hotline, 5334 0388 for patient enquiries (office hours: Monday to Friday, 9 am to 5 pm, excluding public holidays)."
For the reagent delivered to TMH, they have not yet been put into use, and no patients have been affected. CMC and TMH have stopped using the affected batches of reagent and replaced 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 remain unaffected.
A spokesperson stated, "The HA is following up on this event stringently and has notified the Department of Health (DH). We have demanded the supplier concerned to thoroughly investigate its quality control and testing records, provide an explanation, and implement remedial measures. The HA does not rule out taking further action to hold the supplier accountable."
The HA 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.
CHP reminds public to take precautions against cold weather
The Centre for Health Protection (CHP) of the Department of Health (DH) today (January 3) reminded the public, particularly the elderly, people with chronic illnesses, outdoor workers, pregnant women, infants and children, to adopt appropriate measures to protect their health in view of the cold weather.
Photo source: reference image
Elderly and people with chronic illnesses
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A spokesman for the CHP said that in general, elderly people have less insulating fat, and their body temperature control mechanisms would be weaker. Their body may not respond appropriately to the cold weather. In addition, some senior persons may have decreased mobility, which can impair their ability to generate and conserve body heat.
Chronic illnesses, such as hypertension, diabetes or hypothyroidism, would lower their metabolic rate, subsequently causing their body to generate less heat. Besides, persons with chronic illnesses, such as chronic respiratory illnesses or cardiovascular and cerebrovascular diseases, are vulnerable to disease aggravation due to cold weather.
The spokesman reminded the public, in particular the elderly and persons with chronic illnesses, to adopt the following preventive measures:
- Take note of the weather forecast. Wear warm clothing, including hats, scarves, gloves and socks, accordingly;
- Consume sufficient food to ensure adequate calorie intake;
- Perform regular exercise to facilitate blood circulation and heat production;
- Stay in a warm environment. Avoid going out in the morning and at night when the temperature is lower, and avoid prolonged outdoor exposure;
- Use heaters with care and maintain adequate indoor ventilation;
- Avoid alcoholic beverages. Drinking alcohol cannot keep you warm. Alcohol accelerates the loss of body heat through dilated blood vessels, resulting in chilling instead; and
- Seek medical advice if feeling unwell.
Infants, children and pregnant women
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Infants and young children are more susceptible to heat loss during the cold weather. The spokesman reminded parents that they should ensure babies are sufficiently warm, but it is also important to keep babies relatively lightly clothed to avoid overheating them. When children engage in outdoor activities, their clothing should be adjusted accordingly, and changed quickly if soaked. Infants, young children and pregnant women should also try to avoid going out in the morning and at night when the temperature is lower.
Parents should observe the following safety measures when putting their children to bed:
- Keep the room well ventilated and at a comfortable temperature;
- Always place babies on their backs to sleep. Leave their heads, faces and arms uncovered during sleep;
- Babies do not need pillows. Place babies on a firm and well-fitted mattress to sleep. Avoid soft objects, pillows and loose bedding;
- Let babies sleep in a cot placed near their parents' bed; and
- Maintain a smoke-free environment.
Outdoor workers
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Outdoor workers should take heed of the weather report and wear appropriate warm clothing for work. Clothing should be changed as soon as possible if soaked. When the Cold Weather Warning is in force, they should take appropriate precautions. They should take a break immediately and seek help and medical attention if feeling unwell.
General public
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In addition, many respiratory pathogens, including influenza and SARS-CoV-2, may have increasing activity and community transmission during winter. Seasonal influenza vaccination is recommended for all persons aged 6 months or above, except those with known contraindications. Persons at higher risk of getting influenza and its complications, including the elderly and children, should receive seasonal influenza vaccinations early. Please see details of the vaccination schemes on the CHP's website.
A person who gets influenza and COVID-19 at the same time may become more seriously ill and would have a higher risk of death. It is important for elderly persons, especially those residing in residential care homes, to receive both a seasonal influenza vaccination and a COVID-19 vaccination. They should also receive an additional booster against COVID-19 according to recommendations as soon as possible. The public should also maintain good personal and environmental hygiene against respiratory illnesses and note the following:
- Surgical masks can prevent transmission of respiratory viruses from ill persons. It is essential for persons who are symptomatic (even if having mild symptoms) to wear a surgical mask;
- Wear a surgical mask when taking public transport or staying in crowded places. It is important to wear a mask properly, including performing hand hygiene before wearing and after removing a mask;
- Avoid touching one's eyes, mouth and nose;
- Wash hands with liquid soap and water properly whenever possibly contaminated;
- When hands are not visibly soiled, clean them with 70 to 80 per cent alcohol-based handrub;
- Cover the mouth and nose with tissue paper when sneezing or coughing. Dispose of soiled tissue paper properly into a lidded rubbish bin and wash hands thoroughly afterwards;
- Maintain good indoor ventilation;
- When having respiratory symptoms, wear a surgical mask, refrain from work or attending classes at school, avoid going to crowded places and seek medical advice promptly; and
- Maintain a balanced diet, exercise regularly, take adequate rest, do not smoke and avoid overstress.
Food-borne diseases, particularly those linked to hotpot cuisine, are also common in cold weather. The following preventive measures should be taken:
- Wash hands before handling and consuming food;
- Do not patronise unlicensed vendors or those with poor hygienic standards while selecting food;
- Wash and cook all food thoroughly;
- Vegetables should be washed thoroughly in clean running water before cooking and consumption. When appropriate, scrub vegetables with hard surfaces with a clean brush to remove dirt and substances, including pesticide residues and contaminants, from surfaces and crevices;
- Shrimps should be fully cooked until the shells turn red and the flesh turns white and opaque;
- For shellfish such as scallops and geoduck, scrub the shells thoroughly and remove internal organs;
- Do not eat any undercooked freshwater aquatic products. To ensure that the food is thoroughly cooked, the centre of the food should reach a temperature of at least 75 degrees Celsius so as to destroy pathogens;
- Most hotpot ingredients should be stored in a refrigerator at 4 degrees C or below, while frozen food should be stored in a freezer at -18 degrees C or below;
- Never use raw eggs as a dipping sauce for hotpot; and
- Use different sets of chopsticks to handle raw and cooked food to avoid cross-contamination.
In addition, when using fuel-burning appliances, especially in indoor areas, the public should ensure adequate ventilation to avoid harmful exposure to carbon monoxide (CO) and prevent CO poisoning.
Fo more health information, the public may call the DH's Health Education Infoline (2833 0111) or visit the CHP's website and Facebook Fanpage as well as press releases of the Labour Department on precautions against cold weather for outdoor workers and their employers when the Cold Weather Warning is in force.
The public may also call Dial-a-Weather (1878 200) or visit the website of the Hong Kong Observatory for the latest weather information and forecasts, or its page on Weather Information for Senior Citizens.
The Centre for Health Protection (CHP), Photo source: reference image
