Cracking the clinical evaluation riddle

CHRIS RULE highlights the importance of the Clinical Evaluation Report (CER) in the wake of patient safety scandals involving medical implants. He provides an insight into how to write and maintain compliant Clinical Evaluation Reports (CERs).

The Clinical Evaluation Report (CER) is becoming an increasingly hot topic in the medical device regulatory world, particularly given scandals including Poly Implant Prostheses’ (PIP) use of cheaper, industrial-grade silicone in breast implants and toxic debris from metal-onmetal (MoM) hip implants. Specifically, PIP breast implants, were deliberately manufactured with industrial grade silicone which resulted in them being two and six times more likely to rupture than other breast implants. In MoM hip implants, the metal ball and metal cup slide against one another during walking or running, resulting in metal potentially being released from other parts of the implant where components connect. This friction causes tiny metal particles to rub off the device into the area surrounding the implant, with serious implications including metal ions such as cobalt and chromium entering the bloodstream. 

A further example of an implant that has come under public scrutiny is the transvaginal mesh. This implant is employed to treat women who suffer from pelvic organ prolapse (POP) by supporting the uterus, bladder and bowels, or stress urinary incontinence supporting the urethra. In certain instances, the mesh was reported to cause serious complications such as tissue erosion. Following these scandals, CERs are now coming under increased scrutiny and they have been thrust into the public eye.