Further recall of antiseptic products (with photos)
The Department of Health (DH) today (September 30) drew the public's attention to the further recall of antiseptic products.
Following the previous announcements on the recall of antiseptic products, the DH has collected products containing a low concentration of chlorhexidine from different brands for micro-organism tests in batches. Preliminary results indicated that Burkholderia cepacia complex and Ralstonia were detected in two products, namely B.M Medi Antiseptic Solution and Uni Cept Antiseptic Solution. In addition, Burkholderia cepacia complex was detected in another product called Pro-Medi Antiseptic Solution. These products contain 0.05 per cent chlorhexidine, which is not classified as a pharmaceutical product under the Pharmacy and Poisons Ordinance (Cap 138).
The above products are all distributed by Sources (U.S.A.) Medicines Ltd. In addition, the company is also voluntarily recalling two other related products from the market, namely B.M Medi Chlorhexidine Antiseptic Solution and Pro-Medi Chlorhexidine Antiseptic Solution. The company has set up a hotline to answer related enquiries during office hours (please refer to the table below).
Currently, the following 13 antiseptic products are being recalled:
As at 4pm today, the DH's Centre for Health Protection (CHP) has identified from the Hospital Authority one additional patient with an implantable cardioverter defibrillator to have been infected with Burkholderia cepacia within the past two years. In addition, during epidemiological investigation the Centre found that two cases of Burkholderia cepacia infection identified among renal dialysis patients previously had been double counted. After adjusting the figures, the CHP has so far recorded a total of 183 patients (involving 84 males and 99 females, with ages ranging from 24 to 100 years; with 172 cases diagnosed at public hospitals and 11 cases diagnosed at private hospitals) affected by the infection. Epidemiological investigations are ongoing.
So far, the CHP has not received infection cases related to Ralstonia.
Currently, products containing a low concentration of chlorhexidine not labelled for use on broken skin or wound care are not classified as pharmaceutical products under the Ordinance. Members of the public should not use these products for wound care or on broken skin. The Pharmacy and Poisons Board of Hong Kong is making reference to overseas regulatory practice of such antiseptic products and considering whether such consumer goods should be regulated as pharmaceutical products. The DH has also collected products containing a low concentration of chlorhexidine from different brands for micro-organism tests in batches. The tests will take about a few weeks and results will be announced as soon as possible.
The DH's investigations are ongoing.
"Members of the public, especially those who have a weakened immune system should pay extra attention to personal hygiene. Registered pharmaceutical products should be used and instructions given by healthcare professionals should be followed if they need to carry out wound care on their own. The public should seek medical advice if in doubt," a spokesman for the DH said.
"Normal saline (solution of 0.9 per cent sodium chloride) is a commonly used cleansing fluid. As it is similar to human body fluid, it does not irritate wound tissues and causes less pain when applied. Antiseptics may irritate the wound or cause an allergic reaction. Generally, a non-infected wound could be cleansed with normal saline and antiseptics are not required, while an infected wound must be managed according to a doctor's instructions," the spokesman added. For more information on wound care, please visit http://www.elderly.gov.hk/english/healthy_ageing/home_safety/wound_care.html
"Burkholderia cepacia complex and Ralstonia are bacteria commonly found in the environment. They are generally not pathogenic to a healthy person, but can cause infections in persons who have a weakened immune system," the spokesman explained.
Members of the public can refer to the appendix for information on registered antiseptic pharmaceutical products containing chlorhexidine as well as sterile saline solution for irrigation. All registered pharmaceutical products should carry a Hong Kong registration number on the package in the format of "HK-XXXXX". People should seek advice from healthcare professionals before using pharmaceutical products.
Reposted from HKSAR Government webpage: