Hyderabad: Procurement of medical devices must be done in a transparent manner, and there must be an expiry date on the products. This has been demanded by consumer forums on the draft regulations which have been formulated by the Central Health ministry on medical devices. Patients procure medical devices via hospitals and are not aware of their expiry dates.
Advocate M. Srinivas said, “There is a shell-life for all products and it is important that it is utilised within that time. With dental and ortho-paedic implants and stents being used widely, it is important to have these regulations.”
Devices have been categorised according to risk, from Class A carrying the lowest risk to Class D with the highest risk. The Drug Control Authority is supposed to monitor Class B, C and D products.
A senior drug control officer said, “Medical devices have to undergo quality checks we need laboratories. Like in the case of knee replacement surgeries, there have been cases where the implant has been rejected by the body. It has to be evaluated whether the rejection was due to a medical cause or because of the implant.”
Clinical cases of rejections, non-acceptance or complications after the implantation have to be registered. Hospitals have been asked to procure devices from manufacturers registered with the FDA. A hospital official said: “As the medical device industry is not regulated, there is a grey area and a few products that do not have the approval are in the marketThis comes to light only when there is a complication.”
