Update on the safety of treatment tables

Thousands of height-adjustable treatment tables are in use, for example in hospitals and physiotherapy practices. The height adjustment facility in particular has caused crush injuries, fractures and even fatalities among employees in the past.

In 2019 and 2020, KAN arranged two expert discussions involving the stakeholders (the accident insurance institutions, Federal Institute for Drugs and Medical Devices (BfArM), German regional authorities, operators, social partners, standards bodies). Those attending discussed ways of making treatment tables safer. Numerous activities have been launched, and some hurdles have already been overcome. Preliminary results were reported in more detail in KANBrief 4/20.

A result of the expert discussions was that in December 2020, the German supreme state authorities responsible for medical devices and the BfArM published a new document containing information and requirements on the safety of treatment tables. One of the requirements upon manufacturers that is addressed in the document is that they observe the updated BfArM recommendation for treatment tables with power adjustment to be designed such that the tables are not able to trap persons in the adjustment mechanism and thereby cause serious injury. A guide for operators is also included, providing information on the purchase and operation of treatment tables with electrical height adjustment.

The expert discussions and other discussions over and beyond them revealed considerable uncertainty on the market at the present time. A range of information for operators and manufacturers has therefore been published or is currently in preparation, coordinated by a public information working group established for the purpose:

• The German Social Accident Insurance Institution for the health and welfare services (BGW) and the Institute for Occupational Safety and Health of the DGUV (IFA) have together published a sample risk assessment to assist operators in risk assessment of the treatment tables.
• Operators can obtain sample declarations for new treatment tables and retrofits from the BGW. By means of these declarations, the manufacturer confirms observance of the BfArM recommendation.
• The IFA is currently working on practical guidance for manufacturers to support them in evaluating possible technical solutions.
• A list of the most important questions frequently asked by manufacturers and operators, and the corresponding answers, is also being developed.

A further result of the expert discussions was that a project was launched for a prestandard governing treatment tables. Together with the BGW and the IFA, KAN closely monitored work on this prestandard and coordinated its content with the other OSH stakeholders. DIN VDE V 0750-2-52-2:2021-10, Medical electrical equipment – Part 2-52-2: Particular requirements for basic safety and essential performance of couches, has been published and is available from the DKE.

The scope of the prestandard is broad, covering for example treatment tables serving as medical devices and those not placed on the market as medical devices, and treatment tables either with or without height adjustment. This national prestandard is an important step towards greater safety. The objective however is a European harmonized standard. This would apply across Europe and, in the case of treatment tables constituting medical devices, would give rise to a presumption of conformity with the relevant requirements of Regulation (EU) 2017/745 governing medical devices. For other electrically height-adjustable treatment tables, it is intended to give rise to a presumption of conformity with the Machinery Directive 2006/42/EC. KAN will also continue to monitor the progress towards a harmonized European standard closely.

Dr. Anna Dammann
dammann@kan.de

More detailed information and links to the publications referred to above have been compiled on the BGW website (in German): www.bgw-online.de/therapieliegen