Mumbai: The Food and Drug Administration (FDA) has issued show cause notices to three hospitals for reusing catheters in angioplasty procedures. FDA officials said Fortis Hospital in Mulund, Fortis-Hiranandani Hospital, Vashi and BSES Hospital, Andheri were found to be reusing these drug-notified medical devices on multiple patients without taking their consent. As per rules laid down by the Drug Controller of India, 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.
“I had received information about how some hospitals were making enormous profits by re-selling reused catheters. We formed a special team and conducted raids,” FDA Commissioner Harshdeep Kamble said. During the raid, FDA officials found that reused drug-notifiable medical devices were used on 45 patients at Fortis Hospital, Mulund, 27 at the Vashi hospital and 69 patients at the Andheri hospital.
While the catheters are single-use only, doctors say reusing them after sterilisation is a widely-followed practice. Dr. Dev Pahlajani, a cardiologist, said in the past, doctors reused these devices to cut costs for patients. “However, if they are not sterilised properly, they can carry HIV or Hepatitis B infections. Also, due to multiple use, there is chance of breakage as well,” he said, adding patients and relatives have the right to know if the devices are used.
A spokesperson for Fortis Hospital, Mulund and Fortis-Hiranandani, Vashi said they have received the FDA notice. “We will evaluate the observations shared, and respond appropriately,” the spokesperson said.
