MoH warns of two medical methods due to technical problems

The Ministry of Health and Community Protection warned of two medical methods, one of which is not in conformity with the approved specifications, and the second due to technical problems, and it called on all health facilities and primary health care practitioners in the private sector to take the necessary measures regarding them based on the warnings issued.

In detail, the Ministry warned in a recently issued circular "Model 8637 SynchroMed ™ II Implantable Drug Infusion Pump", after the manufacturer stated that it had received eight reports stating that the pump had stopped leaking, which would cause an incomplete treatment of the patient.

The Ministry recommended health care practitioners who work on the aforementioned injection pump, to be aware of the warnings and alerts on the device’s program, indicating that the product was distributed in the country, according to the local supplier.

The ministry said that the product is not registered with the Food and Drug Administration, and requested to contact it in the event of any side effects.

In another circular from the medical method, "OPTIONAL APEX HOLE ELIMINATOR (HE) USED WITH PINNACLE® CUP DEVICES," the ministry warned, after the manufacturer stated that there is a possibility that the devices do not match the approved specifications, as it was found that the diameter of the device is large.

It stated that the affected batches were manufactured with the same machine tool from July 2017 to November 2020, noting that the product is not registered in the Ministry of Drug Administration.

The Ministry called on primary health care practitioners to exercise caution when installing the device to ensure that it was properly inserted vertically, and doctors who treated patients using the affected devices should follow up their patients after surgery in accordance with the standards of medical care.

And since the supplier distributed the affected products within the country, the concerned authorities requested to contact the approved agent to take the necessary measures regarding the product.

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