A new ISO global standard developed by MeDe Innovation researchers has recognised that total hip-joint prostheses need to be tested beyond the ‘normal’ walking gait to better predict the risk of failure in patients.
For the first time, medical device companies have a globally relevant and recognised approach to evaluating hip implant designs and materials that acknowledges that not every patient is the same.
“A patient’s range of motion, increased loads, soft tissue laxity and unintended implant positioning can lead to edge-loading on the joint replacement, which can have severe consequences for the patient, possibly accelerating wear and ultimately leading to implant failure” says Dr Louise Jennings, who led the development of the standard with BSI, the UK’s National Standards Body (NSB). “The new standard specifies the test conditions to simulate edge-loading”.
Standards are developed by dedicated panels of experts, within technical committees. A standard undergoes various stages of development, including public consultation. Then it undergoes further edits until the panel is satisfied with its quality and only when consensus has been reached internationally.
Medical device and implant companies must obtain a CE mark to sell their product in Europe, with similar approaches taken for sales in the USA. Testing against the most current ISO standard provides the evidence of performance ahead of it being approved for use in patients.