New Delhi’s Directorate General of Health Services (DGHS) issued a stern directive on October 16, ordering all states and Union Territories to enforce a complete ban on the reuse of single-use medical devices. The letter targets both public and private healthcare facilities, explicitly prohibiting the sterilization and reprocessing of items designated for one-time use only. This intervention follows a surge in reports that hospitals in critical specialities were repeatedly using expensive equipment, exposing patients to severe health risks.
The scope of the violation is alarming. The DGHS identified cardiac catheters, guidewires, balloon and ablation catheters, and dialysis equipment among the items being misused. In cardiology, nephrology, oncology, and neurosurgery, these devices were reportedly subjected to sterilisation and reused despite manufacturer warnings. The industry body, Association of Indian Medical Device Industry (AiMeD), confirmed that even syringes, needles, and surgical staplers were being reprocessed, a practice that compromises patient safety.
Beyond the health hazard, the directive highlights a financial scam. Patients were allegedly charged the full price for disposable surgical items that hospitals had already used and reprocessed. In some cases, government authorities reimbursed these inflated costs, effectively subsidizing the misconduct. The DGHS warned that sterilisation does not guarantee the safety of single-use devices; improper reprocessing can leave biological material behind, leading to cross-infections including hepatitis B, hepatitis C, and HIV.
The order cites potential violations of the Drugs and Cosmetics Act, 1940, the Medical Devices Rules, 2017, and the Clinical Establishments Act, 2010. Chief secretaries, state health officials, and drug controllers across the country have been instructed to inspect facilities and ensure strict monitoring. The DGHS emphasized that all devices must be utilized strictly according to the Original Equipment Manufacturer (OEM) recommendations. Authorities will now begin compliance checks, with legal action threatened against any facility found in violation.