4 medical devices have been withdrawn due to manufacturing defects

Abu Dhabi Health Authority: Corona vaccination and the supporting dose are a condition for health professional licensing

• Vaccination aims to address the “Covid-19” pandemic and limit the spread of the virus.

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The Abu Dhabi Department of Health announced that obtaining the “Covid-19” vaccine and the booster dose has become a prerequisite for licensing, or renewing the license for health professionals of all categories, with the exception of health professionals who are medically exempt.

Circulars were directed to pharmaceutical facilities, health care facilities, and health professionals, to withdraw four medical devices, based on notifications issued by the Ministry of Health and Community Protection, due to manufacturing defects.

In detail, the department decided, as of January 31, that obtaining the “Covid-19” vaccination is one of the conditions for licensing, or renewing the license for health professionals, of all categories (except for health professionals who are medically exempt from obtaining the vaccine), noting that it has become Any health professional must be fully vaccinated against “Covid-19,” including the booster dose, before submitting an application to obtain a license or renew a license to practice the profession.

She stressed the need to attach a copy of the vaccination certificate from the Al-Hosn application through the department's electronic system, to prove that the applicant has received the vaccination, while the medically exempted persons from obtaining the vaccine will be obliged to attach a copy of the official medical exemption with the license or renewal application.

On the other hand, the department indicated that the arterial line, venous line and safe lin 5008 bloodlines, manufactured by Care Medical Fresenius, have been withdrawn, based on the safety notice issued by the Ministry of Health and Community Protection, due to the manufacturer receiving reports of a leakage from the Main tube with alpha clamp, as a result of an error in the gluing process during production.

The department also decided, based on the ministry’s notification, to withdraw the medical device, Dilatation Catheters Hurricane™ RX Biliary Balloon, which is manufactured by Boston Scientific Corporation (BSC), and attributed the reason for withdrawing the medical device to the complaints reported due to the holes contained in the balloon, where the user may notice that the balloon It either loses pressure quickly, or fails to gain or maintain pressure.

The department withdrew the medical device, the Vacutainer Blood Collection Tube, due to the possibility of the tubes being filled with an incorrect proportion of blood additives, which might give false test results that may lead to incorrect diagnosis or treatment.

The department pointed out that the fourth medical method to be withdrawn is non-absorbent towels with adhesive, due to the different level of adhesion, which leads to the towel not sufficiently attached to the patient.

If the defect is not noticed, it may lead to the towel moving or falling, poor barrier protection, and an increased risk of non-specific infection, especially in patients who are immunocompromised.

The department called on pharmaceutical facilities, health care facilities, and health professionals, to withdraw the specified medical operations and means, return them to the supplier, and report any side effects resulting from their use to the pharmacovigilance program through the program's electronic reporting system.

• The Department of Health in Abu Dhabi requested to attach a copy of the vaccination certificate from the Al Hosn application through its electronic system.

home medical visits

The Abu Dhabi Department of Health decided to extend the decision to allow home medical visits for groups at risk of infection with the Corona virus “Covid-19”, in the event that they cannot be treated using telemedicine services.

The decision allows the continued activation of the home visits service for all types of health insurance documents and treatment programs in Abu Dhabi, for patients from groups vulnerable to infection with the Corona virus.

It includes categories: elderly patients (over 60 years old), and patients suffering from chronic diseases (such as heart disease, diabetes, chronic respiratory diseases and cancerous tumors), based on what has been determined by the World Health Organization.

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