Maha FDA, State Department To Work Out Reuse Of Medical Devices

Mumbai, 11 Feb 2019: Can medical devices and consumables be reused to bring down the cost of procedures? Officials from the Mahatma Jyotiba Phule Jan Arogya Yojana (MJPJAY), the State’s medical insurance scheme for the poor, and the Food and Drug Administration (FDA) are discussing the feasibility of this to reduce costs of procedures.

While the discussions are in a preliminary stage, the authorities hope that if medical procedures can be done at lower costs, top private hospitals that have refused to be a part of MJPJAY may change their mind.

“We have had one meeting to discuss this. The possibility is also being discussed at a national level under the Pradhan Mantri Jan Arogya Yojana (PMJAY),” Dr. Sudhakar Shinde, chief executive officer of MJPJAY, said.

Reuse of devices like catheters, balloons and guide wires is widely accepted in the West. In many countries, dedicated agencies take care of sterilising and repackaging the device for reuse. Activists say a strong lobby of device makers and their nexus with policymakers is responsible for the lack of rules on reuse of such devices in India.

FDA commissioner Pallavi Darade said infection control is crucial when it comes to reusing. “We will have to work out the intricacies. It is not as simple as just allowing the hospitals to reuse. How many times can a device be reused, who will assure that the sterilisation is being done properly? We will have to look deep into the issue,” Ms. Darade said.

In 2017, the FDA had pulled up many hospitals for reusing drug-notified medical devices on multiple patients without taking its consent. Barring one hospital, all others were blatantly billing the patients for the reused device. Till the FDA’s action, many hospitals in the city reused devices after sterilisation by ethylene oxide treatment, but only a few were doing so to genuinely cut costs for patients.

Cardiologist Dr. Prafulla Kerkar from the civic-run KEM Hospital said there is absolutely no clarity from regulatory authorities on the aspect of reuse. “At present, the FDA simply goes by the packaging of the devices, which label them as single-use devices or single-use disposables,” Dr. Kerkar said. All the stakeholders have to come together to arrive at a consensus and clarity on this aspect, he said.

Senior cancer surgeon and medical director of BSES Hospital, Dr. Ashok Mehta, said there is enough literature on reuse of devices being common in various parts of the world. “Why should a country like ours where there are so many poor patients not allow this?,” Dr. Mehta asked. He suggested that a pilot scheme be started in a few hospitals to study the concept.

A 2017 paper published in the Indian Heart Journal said the devices that can be reused should be clearly defined, a meticulous process for disinfection and sterilisation followed and its functionality ascertained before use. “Further, appropriate consent should be obtained where necessary and the cost saving entailed should be directly passed on to the patient,” it said.The Hindu