Sustainable Healthcare

Towards Sustainable Healthcare:
Standards for Reusing Single-Use Medical Devices

Medical devices are integral to modern healthcare, playing a vital role in the prevention, diagnosis, treatment, and rehabilitation of various diseases.

They range from simple tools such as tongue depressors to complex instruments like surgical tools and diagnostic imaging systems, all designed to ensure the safe and effective care of patients.

Given the significance of medical devices in healthcare, the World Health Assembly, in its resolution WHA60.29 adopted in May 2007, emphasized the critical need for the appropriate use and management of health technologies, including medical devices.

The practice of reusing single-use medical devices began in the late 1970s as a method to reduce healthcare costs. In the United States, approximately 20 to 30% of hospitals report reusing at least one type of SUD. In developing regions such as Africa, Asia, Eastern Europe, Central America, and South America, the reuse of these devices is common, though often performed within hospitals under unregulated conditions. This practice has sparked significant controversy due to the associated risks of infection and device malfunction.

While the U.S. Food and Drug Administration (FDA) has established a regulatory framework to ensure the safety of reprocessed devices, including stringent guidelines for labeling and tracking. India has yet to implement similar regulations. Although India revised its regulatory landscape for medical device importation and manufacture in 2017, it does not specifically address the reuse of SUDs. In the absence of formal regulations, in-house reprocessing of SUDs is a widespread practice in Indian hospitals, often conducted without rigorous oversight. This lack of regulation raises serious safety concerns, particularly regarding the risks of infection and device malfunction.

What is single-use devices
A SUD is a medical device that is recommended for use once (i.e. in only one patient for a single procedure). Such devices are not intended by the manufacturers to be disassembled, cleaned, reassembled, and reused, since doing so may jeopardize its physical and/or chemical integrity, performance, safety, and effectiveness.


What is reusable devices
The US Food and Drug Administration (FDA) defines reusable medical devices as those “devices that health care providers can reprocess and reuse on multiple patients.”

  • Raise Awareness: Educate patients, caregivers, and healthcare providers about the current practices and risks associated with the reuse of single-use medical devices in India.

  • Discuss Regulatory Gaps: Address the absence of comprehensive regulations in India governing the reuse of SUDs and the need for a robust policy framework.

  • Emphasize the Importance of Explicit Consent: Highlight the ethical necessity of obtaining explicit patient consent before reusing any single-use device, ensuring that patients are fully informed about the potential risks and benefits.

  • Promote Best Practices in Reuse and Disinfection: Provide guidance on best practices for the safe reuse and disinfection of SUDs, aimed at minimizing the risk of infection and ensuring the safety of patients and healthcare professionals.

  • Encourage Stakeholder Engagement: Foster dialogue among healthcare providers, policymakers, and patients to collaboratively develop and implement safe and effective reuse policies in India.

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