The Paolo Macchiarini case

Summary of Karolinska University Hospital's actions due to surgeries performed by Paolo Macchiarini at the hospital.

Paolo Macchiarini was employed as a physician at Karolinska University Hospital in 2010, and in 2013 his employment ended. In 2011 and 2012, during his employment, he performed transplantations of synthetic tracheas on three patients. All of them died. Macchiarini was convicted by Svea Hovrätt, Svea Court of Appeal, in 2023 of aggravated assault as a result of these operations.

Since Macchiarini's employment ended, Karolinska University Hospital has clarified and tightened up the procedures and regulations for medical patient responsibility. The responsibility for ensuring that clinical research complies with applicable regulations has also been clarified. The hospital's legal office has been given a clearer role and responsibility for regulatory compliance. Karolinska has also implemented several additional measures, such as the establishment of a whistleblower function and a council for the assessment of unproven treatment methods to prevent something similar from happening again.

Karolinska University Hospital's action plan to prevent incidents of this kind from happening again has largely been based on the external review of Paolo Macchiarini's activities at the hospital carried out by Kjell Asplund, former Director General of the National Board of Health and Welfare.

The former CEO of Karolinska University Hospital, Melvin Samson, has conveyed the hospital's apologies to the patients who were affected and their relatives.

The following measures have been introduced at Karolinska University Hospital to prevent something similar from happening in the future:

Support for managers and employees through a guide and a certificate for the division of responsibilities between Karolinska Institutet and the hospital.
A routine and an independent committee have been set up to provide ethical guidance and support to managers on the use of unproven methods.
A guideline has been introduced regarding the multidisciplinary conferences that are the core of highly specialized care. These conferences will follow the same structure throughout the hospital and contribute to a clearer division of responsibilities and higher quality.
Rules for who is allowed in the operating theatre have been introduced, which aim to ensure ethics, traceability and hygiene.
A GCP (Good Clinical Practice) course has been developed in collaboration with the Swedish Medical Products Agency. This course is now mandatory for all directors of medical units and theme and function managers.
A review of the recruitment procedure at the hospital has been conducted, which has led to a simplified and clarified recruitment process, clarified roles and responsibilities, quality controls, and a new joint routine between Karolinska Institutet and Karolinska University Hospital for combined employment.
A reverse duty to provide information has been introduced in the case of secondary employment, so that the employee is obliged to state secondary employment. This aims to give the employer an accurate snapshot of current secondary occupations at any given moment and makes it easier to have the necessary dialogues with employees in these cases.
A roadmap for all employees in how we work based on the hospital's values, laws and guidelines, has been launched.
A whistleblower service exists, where employees can anonymously report misconduct.
In addition, a discussion regarding the described phenomenon of "culture of silence" has involved managers at all levels within the framework of leadership development and is an ongoing work.