New Delhi: The central government has issued a directive to all states and Union Territories, mandating the strict enforcement of a ban on the reuse of single-use medical devices and disposable surgical items across both public and private healthcare facilities nationwide. This measure aims to mitigate significant risks to patient safety, prevent the spread of infections, and address concerns regarding fraudulent billing practices.
Information was available with The Chenab Times indicating that the Directorate General of Health Services (DGHS) had received reports of several private and corporate hospitals sterilising and reintroducing devices intended for one-time use. This practice was noted to be particularly prevalent in critical medical specialities, including cardiology, nephrology, oncology, cardiothoracic and vascular surgery, and neurosurgery.
The DGHS highlighted in a communication dated October 16 that such devices, after being used in a single procedure, were being subjected to sterilisation and subsequently reused, despite their explicit designation as single-use items. This practice raises serious concerns pertaining to patient safety, effective infection prevention and control protocols, adherence to regulatory mandates, and overall healthcare expenditure.
Further concerns were raised regarding instances where patients were allegedly charged the full cost for these reused devices. In some cases, these costs were also reimbursed by government authorities, compounding the issue of financial impropriety alongside the health risks.
A range of medical equipment has been identified as being subject to this illicit reuse. These include cardiac catheters, guidewires, balloon and ablation catheters, introducer sheaths, dialysis equipment such as dialysers and blood tubing, surgical staplers, laparoscopic trocars, and orthopaedic drill bits. The Association of Indian Medical Device Industry (AiMeD) has also pointed to syringes and needles as items being reused.
The DGHS cautioned that even after sterilisation, devices designed for a single use may not achieve the required safety standards for reintroduction. Inadequate reprocessing or material degradation can compromise their functional integrity and potentially leave residual biological material, posing a direct threat to patient well-being.
The reuse of these devices can expose patients to a spectrum of cross-infections, including Hepatitis B and C, HIV, and various bacterial infections. Furthermore, it can lead to device malfunction, reduced performance efficacy, and an increased incidence of procedure-related complications, the directorate warned.
This practice is understood to contravene several key legislative frameworks, including the Drugs and Cosmetics Act, 1940, the Medical Devices Rules, 2017, and the Clinical Establishments Act, 2010. It also likely violates applicable guidelines for infection prevention and biomedical waste management, further underscoring the legal ramifications of such actions.
Consequently, a decision has been made to strictly prohibit the reuse of single-use medical devices and disposable surgical items across all healthcare organisations. This prohibition extends to both public and private healthcare facilities operating under the administrative purview of the Government of India, as well as all states and Union Territories.
The DGHS has formally requested that chief secretaries, state health department officials, directors of health services, the Drug Controller General of India (DCGI), and state and UT drug controllers implement stringent vigilance and ensure effective enforcement of this directive. Healthcare establishments are to be subject to regular inspections and monitoring to ensure compliance, with appropriate punitive actions to be taken against any entities found in violation.
All single-use devices and disposable surgical items must be utilized strictly in accordance with the manufacturer’s instructions and recommendations. The directive also referenced a Central Government Health Scheme (CGHS) office memorandum from December 2016, which previously addressed the reuse of such devices in hospitals empanelled under that scheme.
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The Chenab Times News Desk
