Two studies published in JAMA Internal Medicine have come to the same conclusion: The Food and Drug Administration is doing a poor job of regulating medical device safety.
One study, conducted by researchers from the National Center for Health Research, analyzed the 501(k) process — the process FDA uses to clear implanted medical devices. Rather than requiring clinical testing, the FDA requires the applicant to provide evidence the device is "substantially equivalent" to one already on the market. The applicants must submit the evidence to the agency and create a least a summary of the data to make publicly available.
Of a 50-device sample of devices cleared in 2008, only 16 percent had publically available scientific data supporting their "substantially equivalent" claims. Of the devices already on the market invoked by manufacturers, only 31 of 1,105 had data supporting substantial equivalence, most of which was nonclinical and only some of which went into the safety and efficacy of the devices.
The other study, conducted by researchers from the Pew Charitable Trusts, evaluated the FDA's postmarketing safety and efficacy surveillance of approved, high-risk medical devices. The study examined postapproval studies the FDA ordered for devices between 2005 and 2011. It found small sample sizes, delays in reaching protocol agreement and unavailable findings may have underminded the purpose of the postapproval studies: To collect relevant and timely information on the performance of the approved devices.
While both studies note the FDA is in the process of improving its safety regulations for medical devices, critics note the agency may have a difficult time achieving rigorous safety aims, as it must strike a balance between encouraging medical innovation and acting in the interest of public health, according to a report from The Philadelphia Inquirer.
More articles on accreditation:
Virginia Mason offers hip, knee replacement warranties
4 resources for perfect credentialing
Retained surgical items due to teams, not individuals, study finds
One study, conducted by researchers from the National Center for Health Research, analyzed the 501(k) process — the process FDA uses to clear implanted medical devices. Rather than requiring clinical testing, the FDA requires the applicant to provide evidence the device is "substantially equivalent" to one already on the market. The applicants must submit the evidence to the agency and create a least a summary of the data to make publicly available.
Of a 50-device sample of devices cleared in 2008, only 16 percent had publically available scientific data supporting their "substantially equivalent" claims. Of the devices already on the market invoked by manufacturers, only 31 of 1,105 had data supporting substantial equivalence, most of which was nonclinical and only some of which went into the safety and efficacy of the devices.
The other study, conducted by researchers from the Pew Charitable Trusts, evaluated the FDA's postmarketing safety and efficacy surveillance of approved, high-risk medical devices. The study examined postapproval studies the FDA ordered for devices between 2005 and 2011. It found small sample sizes, delays in reaching protocol agreement and unavailable findings may have underminded the purpose of the postapproval studies: To collect relevant and timely information on the performance of the approved devices.
While both studies note the FDA is in the process of improving its safety regulations for medical devices, critics note the agency may have a difficult time achieving rigorous safety aims, as it must strike a balance between encouraging medical innovation and acting in the interest of public health, according to a report from The Philadelphia Inquirer.
More articles on accreditation:
Virginia Mason offers hip, knee replacement warranties
4 resources for perfect credentialing
Retained surgical items due to teams, not individuals, study finds