8.2 Detection and Notification of Harm to Recipients

It is clear that adverse outcomes following transplantation can be caused by diverse factors unrelated to the quality, safety or specific characteristics of the MPHO applied in the clinical setting. It is very important, however, that the treating physician should always consider the possibility that the MPHO might have been the source of a problem in a recipient.
The treating physician plays a pivotal role in detecting and then reporting adverse patient outcomes that might be associated with the MPHO, to the appropriate authority. These might be transmitted diseases and graft failures, or quality related issues that could imply errors in processing, storage, transport or handling. Without this information, organizations providing MPHO might continue to distribute infected or otherwise unsafe products for multiple patients.
There are many cases in the scientific literature where physicians did not report adverse outcomes such as patient infections, assuming that they were a complication of surgery when in fact they were transmitted by the MPHO and subsequent infections of other recipients could have been avoided.