Re-use of disposable devices: ‘Three hospitals employed single-use catheters on multiple patients’

Following investigations, the FDA has cracked the whip on BSES Hospital, Andheri, Fortis Hospital, Mulund, and Fortis Hiranandani Hospital, Vashi, alleging that the hospitals sterilised balloon catheters and guiding catheters after one angioplasty and reused them on another patient.

According to investigating officials, Fortis and Hiranandani hospitals kept charging each patient for the device, not informing them it had been pre-used. The practice is not just labeled unethical, but also goes against legal provisions of the Drug and Cosmetics Act, 1940. While BSES denied the allegation, the Fortis hospitals said they would “respond appropriately”.

The crackdown comes after the National Pharmaceutical Pricing Authority capped prices of stents in February this year and asked hospitals and manufacturers to abide by the maximum price limit. The cost of cardiac procedures has dipped considerably with the NPPA pricing policy. Hospitals have also been asked to display retail prices of stents.

In March, the FDA received complaints of multiple device usage during cardiac procedures, wherein certain hospitals devised a way to widen their profit margin by reusing a device. “The next patient was charged a little less for the reused device, but charged nevertheless,” said Dr Harshdeep Kamble, FDA commissioner.

The inspections were carried out in the past 15 days by Assistant Commissioner Madhuri Pawar, drug inspectors Kondiba Gadewar, Dhananjay Jadhav, Sheetal Deshmukh and Prakash Mahanwar.

According to the report accessed by The Indian Express, Hiranandani Hospital (Vashi) reused 66 guiding catheters and balloon catheters for 45 angioplasty procedures, Fortis Hospital used 44 catheters for 27 patients and BSES used 95 catheters for 69 patients.

Under the Rule 65 (17) of Drugs and Cosmetics Act, a provision says that medical devices should be used according to the manufacturer’s listed instructions. These devices clearly mentioned “for single use only” on their packages.

The FDA’s documents showed that Fortis hospital charged the first patient Rs 26,000 for a balloon catheter (Clearline Newtreck).

For the second patient, the charge reduced to Rs 20,000. Similarly, Hiranandani Hospital charged the first patient Rs 21,000 and the second Rs 10,500 for a balloon catheter (Coronary Treck). BSES hospital was found to have charged only the first patient, an amount of Rs 17,100 for a Balloon NC Treck Abott. It did not charge subsequent patients for the same catheter.

According to Dr B K Goyal, head of interventional cardiology at Bombay Hospital, reuse of medical devices can help poor patients by cutting down angioplasty cost by at least Rs 30,000.

“We have, however, stopped reuse after the government issued guidelines,” Goyal said.

These devices are generally re-used three to six times. In the latest edition of Indian Heart Journal, multiple authors have argued that medical devices are reused worldwide and this ensures cost reduction for poor patients if practised with standard disinfection procedure.

The study suggested that 20-30 per cent US hospitals reuse single-use devices. In India, the process is skewed with no regulation on reprocessing of devices or special consent from patients.

In USA, hospitals that reuse medical devices call themselves ‘third party processor’ wherein they clean, disassemble, disinfect, reassemble, inspect, test and sterilise the device before reusing.

A follow-up is carried out with the patient after the medical procedure to ensure no endotoxic infection has spread.

The FDA has now issued notices to Fortis and Hiranandani hospitals. The hospitals stopped multiple device usage on March 30 and April 1 respectively,the FDA claims. BSES hospital will be issued a notice on Thursday.

The hospital authorities can attract an imprisonment for two years under sections of Drugs and Cosmetics Act if found guilty. Dr Ashok Mehta, honorary medical director at BSES hospital, said “We deny multiple use. We also deny that we have charged multiple patients for the same device.”

A spokesperson on behalf of Fortis hospital and Fortis Hiranandani hospital said, “We have received a notice from Food and Drug Administration of Maharashtra. We will evaluate the observations shared and respond appropriately.”

tabassum.barnagarwala@expressindia.com