CHP investigates probable case of botulism
The Centre for Health Protection (CHP) of the Department of Health (DH) today (May 15) is investigating a probable case of botulism following botulinum toxin injections. The CHP urges the public to only receive botulinum toxin that has been prescribed and administered by a registered doctor following a clinical assessment.
The case involves a 32-year-old female patient. According to information provided by the patient, she visited an office in Kings Wing Plaza in Sha Tin on May 4. On-site personnel administered injections of a substance claimed to be botulinum toxin into her legs. The patient believed that the person who administered the injections was not a registered doctor. On May 13, she attended the Accident and Emergency Department of Yan Chai Hospital due to dizziness, numbness in both legs, and blurred vision. She was admitted for treatment. She further developed weakness in her upper limbs today. She is now in stable condition and is receiving botulinum antitoxin treatment. She is clinically suspected to have botulism caused by a botulinum toxin injection.
Epidemiological investigations are still ongoing.
In Hong Kong, botulinum toxin injections should only be performed by a locally registered doctor. Customers should verify the doctor's full name against the list of registered doctors of the Medical Council of Hong Kong as well as their professional qualifications and relevant experience. Injections offered by suspicious sources may contain contaminants or varied dosages, and their quality and efficacy are not guaranteed. One should refrain from receiving them. If feeling unwell, seek medical advice from eligible medical professionals as soon as possible.
Due to weakening of associated muscles and the fact that botulinum toxin may spread and affect other areas beyond the injection site, affected patients may experience drooping eyelids, double or blurred vision, problems with chewing, hoarseness, or even difficulty swallowing, speaking or breathing, which may happen hours, days or weeks after the injection.
The CHP urged the public to observe the following health advice before receiving botulinum toxin injections:
Injections in Hong Kong should only be performed by locally registered doctors;
Understand the procedure, potential risks and possible complications before receiving injections. Consult a doctor for an informed decision;
Do not receive injections from suspicious sources;
Do not receive an injection in the case of a history of allergy to botulinum toxin, or if there is an infection or inflammation on the injection site;
Request the full name of the doctor in writing if referred by a beauty service provider for the procedure, as well as the professional qualifications and relevant experience; and
If symptoms develop after injections, such as muscle weakness or feeling unwell, seek medical attention immediately.
The public may visit the DH's webpage on the differentiation between medical procedures and beauty services, the Drug Database of the Drug Office and the CHP's botulism page for more information.
Source: AI-found images
DH follows up on medical incident reported by Tuen Mun Hospital
In response to Tuen Mun Hospital (TMH)'s announcement of a sentinel event, the Department of Health (DH) today (May 15) said that the DH is investigating the incident and following up with the local responsible person (LRP) of the medical device concerned.
On May 13, the DH received a notification from the Hospital Authority (HA) indicating that air bubbles had been detected in the coronary artery of a 75-year-old male patient during a Percutaneous Coronary Intervention (PCI) performed earlier at TMH. According to the preliminary information provided by the HA, it is suspected that the incident is related to the pressure monitoring set used during the procedure.
As the pressure monitoring set in question is listed under the DH's Medical Device Administrative Control System (MDACS), upon receiving the notification, the DH immediately took the following follow-up actions:
Contacted the LRP of the medical device concerned to ascertain the details and requested the LRP to conduct an investigation and submit an investigation report;
As a precautionary measure, the LRP has been instructed to immediately suspend sales of the affected batch and to contact all users in Hong Kong who are using medical devices from the same batch to advise them to temporarily stop using the affected product. To date, the DH has not received any adverse event reporting regarding this medical device from other users; and
Issued a Special Alert on the DH's Medical Device Division website and notified stakeholders, urging users who possess the affected product to temporarily suspend their use and contact the LRP for follow up.
DH's investigation is ongoing. The DH will continue to maintain close communication with the LRP, closely monitor the situation and take follow-up actions based on the investigation report.
The DH introduced the voluntary Medical Device Administrative Control System (MDACS) in 2004, under which a listing system for medical devices and traders as well as a post-market monitoring system for the products are put in place. All listed medical devices meet the safety, quality and performance requirements. Currently, over 9 000 medical devices are listed under the MDACS. Over the past three years, the DH has not received any safety alerts or adverse event reports involving the pressure monitoring set concerned. In response to the latest international regulatory trends, the Government is formulating the statutory regulatory requirements and will consult various stakeholders as appropriate within this year before submitting the legislative proposal to the Legislative Council. The implementation of a statutory registration system for medical devices aligns with the policy directions set out by the Chief Executive in the 2023, 2024 and 2025 Policy Addresses to accelerate the implementation of reforms to the evaluation, approval and registration mechanism for medical products. The HKSAR Government plans to introduce a bill in the second half of this year to achieve the goal of establishing the Hong Kong Centre for Medical Products Regulation (CMPR) under the DH by the end of 2026. Upon its establishment, the CMPR will systematically consolidate the regulatory functions for Western and Chinese medicines as well as medical devices. By leveraging existing legislation governing Western and Chinese medicines and the proposed statutory regulatory framework for medical devices, the CMPR will comprehensively enhance the regulatory and approval mechanism for medical products, thereby supporting Hong Kong's development as an international Health and Medical Innovation Hub.
Source: AI-found images
