MSD clears defective needles with warning to ‘end user’

The Medical Supplies Division (MSD) of the Ministry of Health has cleared for use a faulty batch of “arterial venous fistula needles” as there are no alternatives available in the country. But it has also stated that the risk of using the defective product lies with “the end user”.

 St. Stone Medical Devices (Pvt) Ltd, India manufactures the arterial venous fistula needle with rotatable wings. The batch in question was imported on the basis of a waiver of registration issued by the National Medicines Regulatory Authority on the instructions of the Ministry of Health. This was because an earlier registration granted to the product and manufacturer had lapsed by the time the procurement was honoured.

Once the batch arrived, it was found that the needles--which are commonly used in kidney patients--were defective and would detach, causing bleeding, health sector sources said.

According to documents, the Medical Devices Evaluation Committee (MDEC) of the NMRA which examined the product found several issues. For instance, the easily rotatable needle hub “does not fixated with the shaft [sic]”. The wings and needle get separated from the AVF [arterial venous fistula]. The AVF needle clamp was “very tight”. The needle was blunt and there were leakages while it was not sharp, was short and would easily detach from the adapter.

The batch was withdrawn, according to a circular sent on July 14, 2023, by the MSD Director. But the NMRA’s MDEC subsequently revoked the withdrawal and authorized the use of the product “with defects at the own risk of the end user”. The circular does not define who the end user is--whether it is the patient or the doctor.

The needles are one in a long list of products imported under the Indian line of credit without regulatory oversight or local registration. It was not immediately clear why the Government had not foreseen the requirement for needles and ordered the required quantities with sufficient lead time from registered suppliers.