News
Defective needles given approval with warning to ‘end user’
View(s):By S. Rubatheesan
The Health Ministry’s Medical Supplies Division (MSD) 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”.
The arterial venous fistula needle with rotatable wings is manufactured by St. Stone Medical Devices (Pvt) Ltd, India. 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 NMRA’s Medical Devices Evaluation Committee (MDEC), which examined the product, found several issues. For instance, the easily rotatable needle hub “does not fixated {sic} with the shaft”. 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 leaks. While it was not sharp, it was short and would easily detach from the adapter.
The batch was withdrawn following a circular sent on July 14, 2023, by the MSD Director. But the NMRA’s MDEC subsequently revoked the withdrawal and authorised 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.
The best way to say that you found the home of your dreams is by finding it on Hitad.lk. We have listings for apartments for sale or rent in Sri Lanka, no matter what locale you're looking for! Whether you live in Colombo, Galle, Kandy, Matara, Jaffna and more - we've got them all!