The human body remains in many ways the most powerful and robust “machine” known - given sufficient time, it can even heal itself from illness or injury. Nowadays, medical devices, namely implants, are available to accelerate and enhance the recovery process for a multitude of conditions from bone fractures, to damaged joints and spinal injury, to just name a few. Bringing foreign substances and parts into the human body however, does not come without risks for the patient, as so called “biocompatibility” needs to be achieved. Therefore, in the production and distribution of medical devices, manufacturers are confronted with high quality standards under regulatory oversight.
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Reducing risk through cleanliness of Implants
Cleanliness is a key factor to ensure the biocompatibility of an implant. The international standard ISO 19227 “Implants for surgery – Cleanliness of orthopedic implants” is a guidance document, intended to assist manufacturers addressing this topic. While handling general requirements from risk assessment to validation of cleaning methods and sampling, it also prescribes a set of tests to demonstrate cleanliness throughout the complete production process.
The European Parliament has adopted the new Medical Device Regulation MDR 2017/745, replacing Medical Device Directive MDD 93/42/EEC and the directive on active implantable medical devices 90/385/EEC. Manufacturers of medical devices are likely to face major changes, one of them being stricter clinical post-market surveillance. Unannounced audits and product checks shall help reducing the risk posed by unsafe medical devices.