Just a couple of days earlier the buzz about the congress introducing the legislation on medical device safety (the proposed "Medical Device Safety Act 2008") was rife, and it still is. The new legislation would enable the to be held accountable in cases where medical device causes harm.



And now it's the talk of newer rules that would make getting approvals for a much longer process than it presently is.

The Medical Device Safety Act 2008 - Implications

The amendment is widely being seen as an instrument that serves as an extension of patient rights and interests. Upto now, once secured clearance from the FDA, the makers couldn't be sued under state laws. A recent Supreme Court Ruling highlighted the fact wherein the consumers weren't able to seek compensation for injuries, medical expenses, etc. This was because if the manufacturers were sued under state laws then there would be a conflict between the federal and the state laws, which isn't allowed.

With the FDA clearance of medical devices being stripped off its "stairway to heaven" status, the manufacturers would need to introduce many measures to leave no stone unturned in ensuring quality production.

However, a contention was raised that if a patchwork approach is employed for medical device approvals it would lead to conflicting labeling and indications on products.

Further, that more lawsuits and delays in newer technologies reaching patients would eventually raise health care costs.

For more insights in to the challenges before the American Health Care industry, kindly visit my blog "Smiling Health."