FDA finds three Mumbai hospitals reusing single-use medical devices
27 April 2017
Within a few months of the government's crackdown on overpriced stents, the state Food and Drug Administration (FDA) had found three Mumbai hospitals guilty of not only reusing the medical devices meant for single use, but also charging each patient for them.
Fortis Hospital in Mulund, Hiranandani Hospital in Vashi, managed by the Fortis group, and BSES Hospital in Andheri had been issued show-cause notices for Drug and Cosmetics Act violation.
"Based on information of recycling and reuse of medical devices on multiple patients, the FDA 's intelligence branch carried out an investigation between March 29 and April 1," said FDA commissioner Dr Harshdeep Kamble, The Times of India reported. "These hospitals reused devices without taking consent or without giving prior information to patients," he added.
The FDA team carried out checks on drug notified medical devices such as guiding catheters and balloon catheters used for angioplasty to remove blockages in arteries.
The raids also revealed the outrageously inflated amounts charged by the hospitals, which were at times as high as around four times the maximum retail price.
Some hospitals charged an MRP of Rs26,000 for catheters they purchased for Rs6,000," said FDA inspector Kondiba Gadewar. According to assistant commissioner (intelligence team) Madhuri Pawar, patients given the used devices after sterilising them were also charged at two of the hospitals. The second users were not charged at BSES.
Catheters cannot be reused under the rules laid down by the Drug Controller of India.
FDA officials found that hospitals would use a catheter on a patient and bill it. ''Later, the catheters were directly moved into an unlicensed premises where they would be sterilised by ethylene oxide treatment and packed for reuse on another patient,'' the FDA said in a statement.
The FDA further revealed that the three hospitals were not taking the consent of patients or their relatives for reusing the catheters. According to an FDA official, the raids were conducted between 29 March and 1 April, He added, Fortis hospitals in Mulund and Vashi had stopped reusing catheters and though, BSES Hospital continued to do so, it was not charging patients for it.