How about a Lemon Law for medical devices?

Gigamole was delighted to read about the Lemon Law for Singapore. Kicks in today! Gigamole wonders why it had taken so long to want to protect consumers, but ne'er mind, better later than never.

Gigamole also wonders how the Lemon Law might protect the patient consumers from faulty medical devices such as heart stents, and other prostheses. It would seem that that the prostheses itself should be covered under the current Lemon Law, since the patient did "purchase" a device. The surgery to implant the device is not covered, as it would be a "service". On the other hand, the surgeon would actually be the retailer of the device, so should be responsible for the replacement of the device if it were faulty within 6 months.

The problem with medical devices is that defects often do not reveal themselves within 6 months. So the patient often has to shoulder the burden of proving that the defect did not live up to expectations of quality.

This raises a further question of who actually provides assurance of quality of the product and who protects the patient consumer from exploitation by manufacturers. One may expect that the HSA, as the government regulator to provide assurances that any device entering the market has an acceptable level of quality and safety. But this is not the case at the moment. The nascent attempts to regulate medical devices ran into bad publicity, and the HSA has since appeared to shrink from doing the right thing.

So now no one knows if the medical devices that are stuck into a patient's body is of acceptable quality and safety. No one knows who is actually protecting the patient consumer. Recently Gigamole has flagged up issues with metal on metal hip implants, transvaginal meshes, cardiac stimulators, heart valves, which have increasingly been cited in various regulatory withdrawals and law suits overseas. But locally, there has only been a deathly silence from the HSA. So no one apparently wants to inform the patient consumer the bad news. No one wants to point the finger at surgeons for retailing faulty devices. Seems to be that the patient's only recourse is through litigation. Even so,  there should be adequate awareness among patient-consumers that there is a problem. Sadly, there is so little local information available for the patient-consumer to use. HSA's silence is certainly not helpful.

Gigamole believes we need a Lemon Law for medical devices. But not just a law,  we need a healthy consumer protection movement for drugs and medical devices.