Undergoing surgery is a traumatic experience requiring complete confidence in the skill of the surgeon and the support staff, the cleanliness of the operating theatre and the sterility of the equipment and medical devices to be used.
It was therefore shocking to read recently that two hospitals in the UK had been forced to suspend surgical operations because at least 24 of the kits to be used were found to be contaminated with human tissue.
An investigation is underway, but it seems certain that outdated equipment and untrained personnel were not to blame. The kits were cleaned in a modern, hi tech, automated sterilisation unit by experienced operators working for a reputable company.
It is fortunate that the contamination could be seen with the naked eye, so that vigilant medical professionals were able to avert a potential disaster. But clearly something went wrong with procedures to allow the contaminated kits to leave the decontamination plant.
Sterilising single use medical devices can be equally problematic – this is not a case of “one size fits all”, and the method must be carefully selected to ensure it is suitable for the item in question. Figures from both the UK MHRA and the US FDA show that the number of medical device recalls are rising sharply.
As medical devices become more complex, achieving and maintaining sterility will be increasingly difficult, and the standards and regulations governing them will be more confusing.
But the penalty for failing to comply could be measured in terms of human lives.