Doctor urges limited use of Boston Scientific's new device

[FUZO]

TweetCHICAGO (Reuters) - Boston Scientific Corp's new leadless implantable heart defibrillator, hailed by some as a breakthrough, should be used on a limited basis until more data are collected, a prominent cardiologist wrote in an editorial of a top medical journal.

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[bandaidwoman]

TweetThat's because we doctors know medical devices pass FDA guidelines with much less rigorous scrutiny than oral, ingested drugs. In fact, devices that had been recalled in Europe, still passed American FDA standards ( ie: some urological devices).
In 1990 an order from Congress that directed the FDA to gather rigorous evidence before a manufacturer can sell medical devices considered to be in the most risky category, known as Class 3. ( which this would be classified as) but the FDA hasn't finished implementing the law! The FDA has allowed hundreds of new Class 3 devices to be sold based on a less rigorous showing -- called a 510(k), after a section of federal law --" that they are "substantially equivalent" to combinations of other products marketed before 1976. "This type of evidence is collected in a laboratory, not with a clinical trial in patients.

The Government Accountability Office , especially under the Obamacare guidelines, is asking the FDA to ask makers of high-risk medical devices that had been allowed under the easier process to submit evidence to the agency backing their products' safety and effectiveness. THis will pose problems for older devices, which may be grandfathered in anyway.