Missed Opportunity for Judicial Intervention

On August 24, 2018, the Supreme Court of India dismissed a Public Interest Litigation (PIL) filed by Rizwan Mohammad Kasim Khan, which sought to halt the unauthorized and dangerous practice of reprocessing and reusing medical devices marked as “Single Use Devices” (SUDs). Despite the petitioner presenting evidence of grave health risks and blatant violations of the Drugs and Cosmetics Act, 1940, the Court stated it was “not inclined to interfere” in the matter. During the proceedings, the Court notably commented orally that granting the requested reliefs would be very onerous on government hospitals, signaling a prioritization of administrative and financial burden over the stringent enforcement of patient safety regulations.

The Crisis of Unregulated Reuse

The petition highlighted a widespread, "blatant" practice in both private and government hospitals where cardiovascular catheters, guidewires, and balloons – specifically labeled for single use – are cleaned, sterilized and reused on multiple patients. This practice is often conducted without the patients’ knowledge or consent, yet they are frequently charged the full retail price for these reprocessed items.

The scientific and health risks associated with this practice are well-documented in the sources:

• Infection and Contamination: SUDs are often not designed for thorough decontamination. Research has shown that even after rigorous cleaning, significant bioburden and organic debris can remain, leading to hospital-acquired infections or the transmission of diseases like hepatitis and HIV.

• Mechanical Failure: Reprocessing can alter a device’s physical characteristics, causing materials to stretch, fail, or break during a procedure.

• Toxic Leaching: Materials used in SUDs can absorb cleaning chemicals, such as ethylene oxide, which may later leach into a patient’s body.

  
  

A Violation of Existing Law

The petitioner argued that the current legal framework already prohibits such activities without a license. Under Section 3(f) of the Drugs and Cosmetics Act, the definition of “manufacture” includes any process for “altering... packing, labelling... or otherwise treating” a drug or device with a view to its sale. The Drugs Controller General of India has clarified that processes like the sterilization and assembly of components attract this definition, requiring hospitals to obtain a manufacturing license, a requirement most hospitals currently ignore.

The Judicial Stalemate and Patient Rights

The Supreme Court's oral concern regarding the "onerous" nature of the reliefs for government hospitals reflects the economic reality that many public health facilities rely on reuse to manage limited resources. However, as the sources indicate, this "hidden cost-saving" comes at the expense of a patient’s Right to Life under Article 21 of the Constitution.

The petitioner maintained that the State has a constitutional obligation under Article 47 to raise the level of public health as a primary duty. By dismissing the petition, the Court missed an opportunity to mandate the formation of an Expert Committee to develop standardized, safe protocols for reuse, as seen in other jurisdictions like the U.S. and Australia.

Ultimately, while the Court sought to avoid placing a heavy burden on the public healthcare infrastructure, the dismissal leaves millions of patients at continued risk of infection and mechanical device failure, without the protection of the very laws intended to safeguard their lives.

Jacob Kadantot

Advocate