3 top hospitals held guilty of reusing Angio Balloon Catheters

Mumbai: The Food and Drugs Administration (FDA) in a recent inspection found that three city hospitals including Fortis’s hospitals in Mulund, Hiranandani Hospital, Vashi and BSES Hospital, Andheri were guilty of not only overcharging patients for medical devices but also reusing catheters meant for single use on 72 patients, and charging them for the same. The FDA has issued show-cause notices to all the three hospitals for reusing balloon catheters meant for single use in angioplasty on multiple patients and thereby violating the Drug and Cosmetics Act.

While speaking with TOI, Dr Harshdeep Kamble, FDA commissioner said "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."

“We visited four hospitals, and were shocked to see that among these, both Fortis hospitals were reusing balloon catheters, and charging patients for the same,” said Harshadeep Kamble, state FDA commissioner. He said that it was distressing to find that reputed hospitals such as Fortis were putting patients’ lives in danger with their unethical practices.

He also added "These hospitals reused devices without taking consent or without giving prior information to patients."

The modus operandi according to the officials was that the devices were, after single use, sent to the pharmacy for charging on the inpatient bill. "Later, these devices were sent to the central sterile supply department where they were cleaned and sterilized using ethylene oxide," they said. FDA’s investigations revealed that Fortis hospital, in Mulund, reused balloon catheters on 45 patients, and in Vashi catheters were reused on 27 patients while BSES Hospital, Andheri, had re-used 95 of these devices for 69 patients.

They also discovered that both hospitals were also overcharging patients to the tune of Rs 15,000. (A balloon catheter costs around Rs 10,000, while the hospitals were charging anywhere between Rs 22,000 to Rs 25,000).

“They were making a tidy profit,” said Kamble. As per medical guidelines, used catheters are to be disposed of. They cannot be sterilized and reused on patients. The FDA also found that there was no proper storage facility for the catheters at both Mulund and Vashi. “Under the Drugs and Cosmetics act, a catheter should be stored properly, but there, they were lying in the open,” said Kamble. The FDA said BSES Hospital was guilty of reusing the catheters, they had not charged their patients, most of who are from the underprivileged sections, any money for the catheters.

According to the hospital, reusing catheters was an accepted practice across the world. “Anything that can be sterilized can be reused provided all care has been taken. Also, we are a charitable hospital, and a large number of our patients are poor, and since they cannot afford a new catheter, we have to reuse the device,” said Dr Ashok Mehta, a medical director at the hospital.

“We have received a notice from Food and Drug Administration. We will evaluate the observations shared, and will respond appropriately,” said Fortis in a statement. Efforts to reach BSES failed. FDA officials said the hospitals have stopped re-use since the raids.