The Maharashtra Food and Drug Administration (FDA) has filed prosecutions against seven hospitals based in Pune, Nagpur, Aurangabad and Mumbai for overcharging patients and also for reusing balloon catheters and guiding catheters on them in violation of Section 18 of Drugs and Cosmetics Act, 1940 and Rule 65.

Balloon and guiding catheters are accessories used in angioplasty procedures for patients with heart blockages.

The state FDA had earlier issued show-cause notices to these hospitals for recycling and reusing single-use medical devices on multiple patients. It was found that these hospitals were reusing medical devices like guiding catheters and balloon catheters used for angioplasty.

The devices after use were 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.

The patients were charged a whopping Rs. 26,000 per piece, more than four times the MRP of Rs. 6,000.

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. Hospitals were found to be making profits by charging patients for the reused devices.

“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 stated that hospitals were not taking the consent of patients or their relatives for reusing the catheters. An FDA official said that the findings came out during inspections between March 2017 and May 2017.

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.