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Compliance In Focus
Posted by John Lehmann on Mon, Jan 21, 2013

Should Certain Devices be Held to a Higher Standard?

Many researchers are proposing a reclassification of all hip joint metal-on-metal hips as thereShould Certain Devices be Held to a Higher Standard? may exist a regulatory loop-hole allowing dangerous devices to reach patients. FDA proposed a new rule that would require these devices to submit a Premarket Approval Application (PMA) which were being accepted through the 510(k) process.

According to the information on Federal Register, the Orthopaedic and Rehabilitation Devices Panel that reviewed the hip joint devices concluded that FDA should not reclassify devices as they have relevant concerns regarding the risk to patients, including:

  • There was insufficient clinical and preclinical testing information to establish special controls
  • The length and rate of long-term patient follow-up data were inadequate to demonstrate the special controls would provide reasonable assurance of the safety and effectiveness of these devices
  • In terms of preclinical testing, the Panel also wanted to investigate wear testing methods which may underestimate bearing wear

Taking these points, other relevant publications, and recent recalls of these devices from the US market have pointed to the fact “that preclinical testing currently used to support marketing clearance of these devices has not been sufficient to mitigate the risks associated with these devices.” What types of risks are patients being exposed to? The paper points to:

  • Loss or reduction of joint function
  • Adverse tissue reaction
  • Increased risk of premature device failure
  • Infection

As minor references are made throughout the paper, it appears that FDA is leaning towards requiring a PMA for certain types of hip devices. This would be a change as many of these devices were slipping through what many considered to be a “loop-hole” in 510(k). In fact in summer of 2012, law makers failed to close loop-holes that allowed devices to be approved if they even if a previous device of a similar model was recalled for a major safety defect.  This loophole has allowed a number of dangerous and defective devices– such as the bladder mesh implants – to go to market.

What are your thoughts on this? Do you believe that FDA should consider reclassification of certain devices? Or, do you think there needs to be a re-work of 510(k) to help protect patients? Share your thoughts with us.

Photo Credit: Kaptain Kobold

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Topics: Medical Devices, Premarket Approval Application, FDA, 510(k)


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