Reusing single-use devices: FDA warns Fortis hospitals

The Maharashtra Food and Drug Administration (FDA) today warned two Fortis hospitals in the city of stringent action for allegedly reusing single-use angio medical devices and overcharging the patients for them.
Members of the hospital management can get two years in jail if found guilty, the FDA said.
"Following our investigation, we've issued show-cause notices to Fortis hospitals at (suburban) Mulund and Vashi (in neighbouring Navi Mumbai) for recycling and reusing single-use medical devices on multiple patients. We will wait for their reply and take suitable action," state FDA commissioner Harshdeep Kamble said here.
Under the law, if found guilty, officials of these hospitals may face imprisonment for two years, Kamble said.

Fortis had received the notices and was "evaluating the observations" and would respond appropriately, its spokesperson told PTI.
The FDA teams investigated another hospital -- BSES Andheri -- and did not find anything inappropriate there, but found two of the Fortis hospitals to have violated the rules.

Kamble said the probe by FDA found that these two hospitals were reusing angio-medical devices such as guiding catheters and balloon catheters used for angioplasty, a heart procedure.
They charged a whopping Rs 26,000 per piece, more than four times the MRP of Rs 6,000, he said, adding the devices were, after use, sent to the pharmacy for billing, and later the same devices were sent back to the hospital's central sterile supply department for sterilisation and reuse.

Fortis hospital in Mulund reused as many as 66 of these devices between January and March, the FDA commissioner said.
FDA is very serious about hospitals violating laws and may impose a ban on sales of devices too, Kamble said.
Meanwhile, the National Pharmaceutical Pricing Authority (NPPA) chairman Bhupendra Singh welcomed the Maharashtra FDA's action.
When pointed out that reuse is allowed in many countries, Singh said there are rules for the manufacturers and they need to follow certain ethics.