The Ministry of Health withdraws a medical device due to a defect that could lead to death
The Ministry of Health and Community Protection decided to withdraw two medical methods, the first as a result of a defect in the product that may cause serious health injuries including deaths of the patient, and the second due to the inclusion of an incorrect expiration date, and it obligated a pharmaceutical company to add warnings about a drug used for high blood pressure.
In detail, the Ministry directed a circular to all health facilities and health care practitioners in the private sector to withdraw two samples of a medical device used to transport fluids and medicines to the patient’s body in specific quantities, produced by "Smiths Medical".
The Ministry attributed the reason for the withdrawal to a defect in the product, which may slow or speed up the delivery of the drug to the patient. Serious health injuries including deaths, indicating that the product is not registered in its drug administration.
In a second circular, the Ministry requested all health care practitioners to withdraw the "BARD 2-Way Foley Catheters", which is a catheter used to extract urine, produced by "Becton Dickinson".
She explained that the reason for the withdrawal is the inclusion of an incorrect expiration date on the label, stressing that the product is not registered in its drug administration.
In a third circular, it called for adding warnings to medicines that contain the medicinal substance (hydrochlorothiazide), which are used as a diuretic treatment for high blood pressure.
The Ministry stressed that the companies producing these medicines and all health care practitioners should update the internal leaflet of the medicines that contain this medicinal substance to include details about the increased risk of non-melanoma skin cancer, which includes basal cell carcinoma (BCC) and squamous cell carcinoma (SCC), in addition to Tips on avoiding exposure to UV rays and having regular skin checks.
She explained that medical care practitioners who treat their patients with a drug containing "hydrochlorothiazide" should educate them about the signs and symptoms of non-melanoma skin cancer and advise them to use effective UV protection and to have regular skin checks.
She indicated that this product is registered in its drug administration, and that it is safe to use and has not been withdrawn from the market.
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