Woke up this morning to the shocking news of HSA's intention to regulate medical devices. More correctly, the shocking news of the doctors' responses to the impending regulations. What crap!
Regulation of medical devices have lagged far behind that for pharmaceuticals, and regulations have been long overdue. While pharmaceuticals require extensive testing for safety and efficacy, medical devices have escaped such scrutiny. As a result many poor quality products have been inflicted on unsuspecting patients. These range from breast implants, stents, artificial joints and various other prostheses. (Consumer Reports reviews this problem with reference to a report from the Institute of Medicine. 4 types of devices were singled out - surgical meshes, lap-bands, hip implants and cardiac devices.)
Recently, the French Company making the Poly Implant Prosthese (PIP) gel breast implants were hit by a major scandal when it was discovered that they had been using industrial grade silicone instead of medical grade ones, leading to the company going into liquidation. Of greater concern than the financial woes of the company was the exposure of unsuspecting women to the increased risk of ruptures of the poor quality implants.
Will the new regulations slow down the utilization of medical devices? Without doubt. But this slow down is necessary until manufacturers and doctors get used to dealing with public expectations of quality. Currently device failure rates are not even being monitored so no one has any idea of of how many faulty devices breakdown or fail.
HSA's regulations are both timely and essential for the protection of consumer safety, and we should welcome them. On the other hand, our doctors' hysterical lamentations that these regulations will only increase their practice inefficiencies and reduce the quality of medical care are misplaced, and sound totally self-serving.
5 years ago