Apart from the knowledge aspect in determining liability, AIMDs are also required to combat other glitches arising in a non-AI medical device requiring 100% human effort. Placing both AI and non-AI medical devices together under the head of ‘medical devices’ pitches further complications to the determination of liability. When non-AI medical devices such as bone cements, surgical dressings, umbilical tapes, etc lack quality or safety as required under the rules, the manufacturer will be the only person liable. This would apply to situations where such devices have been successfully used in the treatment of patients and an inconvenience occurs at a later point of time.
This approach has been undertaken by a US Court, in a case where a medical device called ‘Pinnacle’ was implanted successfully by a medical practitioner, but later on caused health complications to the patient. The Court held the device to be defective and the manufacturing company strictly liable. It could be inferred that the Medical Device Rules has brought in a similar approach in handling failure of medical devices which includes AIMDs, even though the Indian courts are yet to decide any matter on these lines.
Source: Barandbench
