Maharashtra Food and Drug Administration (FDA) may cancel licenses of two Fortis Hospitals based in the city for overcharging patients subject to reusing catheters on them contrary to the existing medical guidelines and also in violation of Section 18 of Drugs and Cosmetics Act, 1940 and Rule 65.

“Besides this, there was no license with the hospitals for storage of medical devices. Violation of the norms amounting to endangering patient safety warrants suitable action. Offenders can get two years in jail if found guilty,” said FDA Commissioner Dr Harshadeep Kamble.

The state FDA had issued show-cause notices to Fortis hospitals at Mulund and Vashi for recycling and reusing single-use medical devices on multiple patients. Fortis had received the notices and was "evaluating the observations" and would respond appropriately. FDA found that these two hospitals were reusing medical devices like guiding catheters and balloon catheters used for angioplasty, a heart procedure.

They charged a whopping Rs.26,000 per piece, more than four times the MRP of Rs.6,000, he said, adding the devices were, after use, sent to the pharmacy for billing, and later the same devices were sent back to the hospital's central sterile supply department (CSSD) for sterilisation and reuse.

FDA is very serious about hospitals violating laws and may impose a ban on sales of devices too. The Mulund based hospital reused as many as 66 of these devices between January and March, the FDA commissioner said.

Reuse is allowed in many countries and there are rules for the manufacturers which need to be followed as per certain ethics. As per rules laid down, catheters cannot be reused. While Fortis Hospital and Fortis Hiranandani were found to be making profits by charging patients for the reused devices, BSES Hospital did not charge the patient for reused devices.

Balloon and guiding catheters are accessories used in angioplasty procedures for patients with heart blockages. “FDA officials found the hospitals would use a catheter on a patient and bill it. Later, the catheters were directly moved into an unlicensed premises where it would be sterilised by ethylene oxide treatment and packed for reuse on another patient,” an FDA statement said. It also said all three hospitals were not taking the consent of patients or their relatives for reusing the catheters. An FDA official said the raids were carried out between March 29 and April 1, and the Fortis Hospitals in Mulund and Vashi have stopped reusing catheters. However, BSES Hospital continues to do so, but without charging patients for it.

During an FDA raid, officials found that reused drug-notifiable medical devices were used on 45 patients at Fortis Hospital, Mulund, 27 at the Vashi Hospital and 69 at the Andheri hospital. While the catheters are single-use only, doctors say reusing them after sterilisation is a widely-followed practice.