Quality of biomaterials, buyer’s responsibility

  • Posted on: December 09, 2021

Who is responsible to ensure the quality of plates, implants, stents, lenses, etc. used for interventions? It’d be hospitals / doctors if it is bought by them on patients’ behalf.

The patient met with a serious road accident but thankfully escaped only with fractures in left hand. He approached a hospital where the orthopaedic surgeons implanted a plate and discharged him the next day.

Five months later he experienced sharp pain and rushed to the doctors. The plate was broken and the patient was advised another minor operation to implant a new plate. But he chose otherwise and visited a hospital where another orthopaedic surgeon performed bone grafting and implanted a new plate.

Clearly unhappy with first operation, the patient sued orthopaedic surgeons and claimed that the plate broke without any external force which established that they were negligent in implanting a low quality plate.

The orthopaedic surgeons stated in defence that the post-operative X-ray clearly showed that the plate was properly fixed and it was in good union. The hospital, strangely enough, claimed in defence that the plate was purchased by the patient!

The Commission perused medical records, including invoice of the plate and stated the following:

“Normally biomaterials like eye lenses, stent, plates, pacemaker, etc. are purchased by the hospital / doctor because patient being a layman does not have knowledge about the quality of such biomaterials”.

“In the present case hospital’s retail invoice shows that the implant was purchased by them. Furthermore invoice issued is in the name of the hospital and therefore there is no contract between the patient and plates manufacturer. Hence the patient is entitled to get the compensation from hospital as they have purchased the plate that was implanted”.

Source: Order pronounced by Gujarat State Consumer Disputes Redressal Commission on 16th September, 2021.