Serious Adverse Events or Reactions in organ transplantation; raising awareness in the Netherlands

K.G. Sparidaens, P.R.J. de Rooij

Friday 16 march 2018

10:15 - 10:20h at Willem Burger Foyer

Categories: Donation, Session (poster)

Parallel session: Poster session 9: Donation

In 2016, the Dutch Transplant Foundation (NTS) received only 15 possible serious adverse event or reaction (SAE/R) reports about a Dutch organ donor or recipient. This number seems low. It may suggest that the knowledge about these reports and the European guidelines is suboptimal in European hospitals. With this article we want to increase the awareness in the Netherlands about SAE/R and raise the number of reports.

Introduction

In 2012, the EU implemented a directive to ensure the quality and safety of organs for transplantation. The directive describes who is responsible for taking certain steps in case of a SAE/R, which can occur in het process from donor reporting up to transplantation and follow-up. If an organ is transplanted across the border within Europe, the national competent authority (NCA) is responsible to report and investigate the incident. In the Netherlands this is the NTS. The countries within Eurotransplant (ET) have made agreements with ET about the procedure.

Notification procedure

If a possible SAE/R is detected, the doctor fills out a special form provided by ET. Thereafter, ET investigates which hospitals are involved and sends an initial report to these hospitals and the NCA. If it concerns a Dutch donor, the NTS receives the report and starts analyzing the SAE/R. Main focus of the investigation is to determine the odds that the cause of the SAE/R is found in the donor and if it may affect the other recipients. The hospitals can use this information to determine if they should monitor their patients more carefully.

European cooperation

In recent years, the ET countries have been looking for a reliable working method for both national and international handling of SAE/R reports. In addition to guarantee quality and safety of donor organs, the ET countries also want to improve and learn from each other. Therefore joint meetings were organized in 2017. As a result of these meetings, the NTS has evaluated and improved its working method. In 2018, the ET countries hope to have a complete list of all SAE/R reports of recent years.

Future

In 2018, the NTS will increase the collaboration with the Dutch hospitals. The expertise of the hospitals and medical professionals is essential for detecting the possible SAE/Rs and patient safety. Therefore the NTS wants to use their knowledge in assessing reports. The NTS expects to receive more reports in 2018 and to collectively increase the quality and safety of organ transplants.