Persbericht, 11 december 2006
Monday 2 October 2006
The Netherlands Health Care Inspectorate has ordered the Preventief Medisch Centrum (PMC) of Rotterdam to stop performing treatments with stem cells as from today. The Inspectorate concluded that the PMC is not providing responsible care, because it is unable to demonstrate the origin, suitability and safety of the stem cells it uses. This situation jeopardises the health and safety of patients. Among other things, it exposes patients to the risk of infection with HIV or Creutzfeldt-Jacob Disease, (acute) allergic reactions, malignant tumours or rejection reactions.
Last Friday, the Inspectorate received a notification from the Havenziekenhuis hospital in Rotterdam about a patient who had to be admitted with serious complications following stem cell treatment at the PMC. The patient had a serious acute allergic reaction after the administering of stem cells. After being treated with anti-allergy medication at the hospital, the patient was allowed to return home.
Under the Care Institutions (Quality) Act, the PMC is required to provide responsible care. This means care of a good level that is efficient, effective and suitable for the patient. In the case of stem cell treatment, the PMC is obliged to demonstrate through documentation the safety of the entire stem cell supply chain from donor to recipient. To date, the PMC has been unable to present any documentation to the Inspectorate concerning the origin, the suitability for the intended application and the safety of the products that are used.
The order took effect at 17:00 hrs today and will remain in place for one week. The Inspectorate will ask the Minister of Health, Welfare and Sport to renew the order after seven days. The Inspectorate is further considering bringing disciplinary charges against the physicians who work at the PMC.
2006-10-09 Extension of order PMC [49Kb]
