| Over the past couple of days developments on the | | | | able to seek compensation for injuries, medical |
| issue of ensuring patient safety have left the providers | | | | expenses, etc. This was because if the manufacturers |
| of health care in the US scratching their heads. | | | | were sued under state laws then there would be a |
| Just a couple of days earlier the buzz about the | | | | conflict between the federal and the state laws, which |
| congress introducing the legislation on medical device | | | | isn't allowed. |
| safety (the proposed "Medical Device Safety Act | | | | With the FDA clearance of medical devices being |
| 2008") was rife, and it still is. The new legislation would | | | | stripped off its "stairway to heaven" status, the |
| enable the medical device manufacturers to be held | | | | manufacturers would need to introduce many |
| accountable in cases where medical device causes | | | | measures to leave no stone unturned in ensuring |
| harm. | | | | quality production. |
| And now it's the talk of newer rules that would make | | | | However, a contention was raised that if a patchwork |
| getting approvals for diabetes drugs a much longer | | | | approach is employed for medical device approvals it |
| process than it presently is. | | | | would lead to conflicting labeling and indications on |
| The Medical Device Safety Act 2008 - Implications | | | | products. |
| The amendment is widely being seen as an instrument | | | | Further, that more lawsuits and delays in newer |
| that serves as an extension of patient rights and | | | | technologies reaching patients would eventually raise |
| interests. Upto now, once medical devices secured | | | | health care costs. |
| clearance from the FDA, the makers couldn't be sued | | | | For more insights into the challenges before the |
| under state laws. A recent Supreme Court Ruling | | | | American Health Care industry, kindly visit my blog |
| highlighted the fact wherein the consumers weren't | | | | "Smiling Health. |