Centre directs states to enforce ban on reuse of single-use medical devices

The Centre has directed states and Union Territories to strictly enforce a ban on the reuse of single-use medical devices and disposable surgical items in public and private healthcare facilities, citing patient safety concerns, infection risks and instances of patients allegedly being charged the full cost of reused equipment, news agency Press Trust of India (PTI) reported.

In a letter dated October 16, the Directorate General of Health Services (DGHS) flagged reports of some private and corporate hospitals sterilising and reusing devices intended for one-time use. The practice was reportedly observed in several specialities, including cardiology, nephrology, oncology, cardiothoracic and vascular surgery, and neurosurgery.

“It has been observed that such devices and disposable surgical items, after being used for one procedure, are being subjected to sterilisation and subsequently reused, despite being designated for single use only,” the letter said.

The devices identified include cardiac catheters, guidewires, balloon and ablation catheters, introducer sheaths, dialysers, blood tubing, surgical staplers, laparoscopic trocars and orthopaedic drill



bits.

The Association of Indian Medical Device Industry also said that syringes and needles were among the items being reused.

The DGHS has asked chief secretaries, state health department officials, directors of health services, the Drug Controller General of India and drug controllers in states and Union Territories to maintain strict vigilance and ensure effective enforcement of the directive.

Authorities have been instructed to inspect and monitor healthcare establishments, ensure compliance and take appropriate action against violations.

“All single-use devices/disposable surgical items should be utilised strictly in accordance with the instructions and recommendations of the Original Equipment Manufacturer (OEM),” the letter said.

The directive also referred to a Central Government Health Scheme office memorandum issued in December 2016 concerning the reuse of such devices in hospitals empanelled under the scheme.

The latest communication reiterates that medical devices and disposable surgical items intended for one-time use must not be reused in public or private healthcare facilities.