KANBrief 4/20
Following several fatal accidents on treatment tables with electrical height adjustment, KAN organized an expert discussion of the design of safe treatment tables at the beginning of 2019. The parties involved discussed their respective positions and launched efforts to reduce the hazard on existing and new treatment tables. The second KAN expert discussion, held in October 2020, showed that significant progress has been made but that much remains to be done.
Treatment tables with electrical height adjustment are indispensable for hospitals and physiotherapy practices. The height adjustment makes it easier for patients to get onto and off the table, and enables the practitioner to adopt an ergonomic posture. In the past, accidents involving such treatment tables have resulted in contusions, fractures and even fatalities among employees. In the fatal accidents, the employee’s knee had inadvertently operated the height adjuster on the floor, causing the table to descend and trap the individual.
At the 2019 expert discussion, the parties involved (the accident insurance institutions, Federal Institute for Drugs and Medical Devices (BfArM), German regional authorities, operators, social partners, standards bodies) assumed various tasks with the aim of making the treatment tables safer in the future. One of these tasks was revision of the 2004 BfArM recommendation concerning treatment tables with automatic height adjustment. This recommendation made reference to a possible technical solution in the form of a safety box with which the operator must deliberately deactivate the height adjustment facility, for example by withdrawing a pin from the box. This feature is intended to prevent accidental raising or lowering of the table. Based on the recommendation, many manufacturers have adopted safety boxes, and many older treatment tables have also been retrofitted with them. However, one of the fatal accidents occurred on a treatment table already equipped with a safety box. The safety pin had not been withdrawn in this case.
The BfArM recommendation has since been revised, particularly with regard to new treatment tables. The revised recommendation requires selected solutions to be based on the principle of integrated safety and thus to be as integral as possible to the design of the product, i.e. at the level of the hoist and drive system. In contrast to the previous version, the new recommendation no longer states specific examples. With regard to legacy treatment tables, reference is made to the 2004 recommendation and thus also to the solution of the safety box.
The German regional authorities responsible for the market surveillance of medical devices have prepared an informative document on a joint approach. Once this document has been adopted, the regional authorities will agree a harmonized approach to surveillance with the accident insurance institutions.
The Institute for Occupational Safety and Health of the DGUV (IFA) has launched a project for evaluation and practical testing of various technical solutions for the design of safe treatment tables. The results are to be introduced into standardization activity.
No specific product standard for treatment tables existed before now. The responsible standardization committee of the German Commission for Electrical Engineering (DKE) has now produced an internal draft for a German technical specification for these devices. In the long term, the intention is for a standard to be created at European and international level.
The range of topics discussed in the second expert discussion was wide: manufacturers fear that competition will be distorted if the treatment tables they offer are safer, but in consequence more expensive than those of their competitors. How can it be communicated more effectively that integrated technical solutions offer greater safety? Several groups are working on information targeted at different audiences. How can the various groups speak with one voice, for example in addressing users of the devices? What aspects must be considered by employers during risk assessment of treatment tables? May treatment tables that have already been upgraded with a safety box have to be upgraded again? Who pays for upgrading?
To answer these questions, participants once again agreed to work on tasks such as:
In a year’s time, the KAN Secretariat will survey the perceived need for a third expert meeting.
Dr Anna Dammann
dammann@kan.de