The European regulatory framework requires that manufacturers of point-of-care diagnostic devices prepare technical documentation containing data demonstrating the safety and performance of the device. In a study performed by the RIVM, commissioned by the Health Care Inspectorate of the Netherlands (IGZ), several shortcomings in this documentation have been observed. Shortcomings in the technical documentation do not necessarily mean that the quality and safety of the devices is insufficient.
Point-of-care diagnostic tests are devices that can be used near or at the site of patients for a relatively fast diagnosis. In the majority of the technical documentation sets, the required education of the intended user and the type of health care setting in which the devices can be used, were not clearly specified. An indication like =for professional use', which was often encountered, is not sufficient.
In addition, important information on the performance of the point-of-care diagnostic devices was not always present. Also, it was often not clear whether these products have been tested in a group of intended users before they were placed on the market. Most manufacturers do offer training to the users of their products when they are on the market.
Furthermore, shortcomings in the risk management process were encountered frequently. To minimize the risks involved in the use of the device, all known or foreseeable risks should be identified, estimated and eliminated or reduced. In the investigation it was found that the technical documentation was often lacking some items. For example, risks that were not eliminated, were not always addressed as warnings in the instructions for use. Also, it was found that manufacturers paid insufficient attention to risk management activities after their product was placed on the market.