India medical device reuse regulation

The Indian central government, through the Directorate General of Health Services, issued a directive to all states and Union Territories to strictly enforce a nationwide ban on the reuse of single-use medical devices and disposable surgical items. This action follows reports that some private and corporate hospitals were sterilizing and reusing equipment in specialties such as cardiology, oncology, and neurosurgery. The government cited risks of device malfunction, performance deterioration, and cross-infections, such as HIV and hepatitis, alongside allegations of financial exploitation where patients were reportedly charged full price for reused items.

In response, hospital chains and healthcare associations have requested the government reconsider these restrictions, citing concerns over treatment affordability and service continuity. Meanwhile, manufacturers and public health experts have maintained that rigorous enforcement is necessary to protect patient safety. Experts have noted that effective oversight may be hindered by inadequate staffing and weak enforcement mechanisms within the private sector, leading to calls for dedicated regulatory personnel and routine medical audits.