Status:

completed 04/2022

Aims:

Due to two fatal accidents experienced by cleaning workers and a wide range of injuries (particularly crushing injuries in the leg area of care/therapy personnel) associated with the operation or cleaning of therapy tables, there was an urgent need to reassess and evaluate the safety equipment of electric and hydraulic therapy tables.

The accidents generally resulted from the unintentional triggering of lowering or raising movements of the therapy tables while people or people’s limbs were positioned in the mechanical substructure of the therapy beds. As part of the project, both safety concepts for therapy tables that are already established and safety concepts that have previously only been used in the context of machine protection are to be investigated with regard to their suitability for use on therapy tables.

The project has two key areas of focus:

1. Options that can be retrofitted to tables that are already in use.
2. Options for technical solutions in new products.

This means that there are two objectives for the project:

1. To identify potential safety concepts that are suitable for a practical retrofit solution on therapy tables. In this case, the focus is on ensuring that the concepts are easy to attach to the therapy tables, and, if applicable, easy to add to the drive technology (to increase the likelihood of user acceptance). Since therapy tables can be purchased for just a few hundred euro, the cost aspect of a retrofitted solution must be considered. User acceptance (therapists, doctors) is another factor that must be considered. It must be assumed that different solutions are required for therapy tables with different designs.
2. Inclusion of the technical solutions in the upcoming standard for therapy tables (DIN EN 60601-2-xx). The draft of the standard was drawn up in DKE/AK 812.9.1 (Energetically operated hospital beds) and is intended to serve as a basis for an international standardisation project at IEC.

Activities/Methods:

The project was separated into the following phases:

1. Market research about which types of therapy tables are available on the market and which safety concepts already exist.
2. Analysis of the work processes associated with the use of therapy tables through field studies (carried out at nearby therapy practices).
3. Development of safety concepts for all types of therapy tables. The safety concepts are also to be tested on therapy tables in the IFA (possibly through field tests).
4. Clarification of technical conditions and environmental conditions regarding the suitability of safety concepts.
5. Definition of which (new) safety concepts can be implemented for existing or new therapy tables.
6. Workshop with manufacturers and operators of therapy tables with a discussion of the results in the IFA.
7. Publication of the results.
8. Inclusion of the safety concepts in the standard.

Results:

The research showed that there are currently still many height-adjustable tables available in Germany without any kind of protective equipment. This protective equipment is intended to protect people from accidents, such as crushing, shearing of limbs, or, in the worst-case scenario, death due to clamping accidents. Despite a recommendation from the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) from 2004, which describes retrofitting therapy tables featuring automatic height-adjustment with a lockout box, not all therapy tables were retrofitted with this function. The lockout box is actually intended to interrupt the power supply to the table when a pin, which is usually magnetic, is pulled out. Since this is an organisational measure, and since it is easy to forget to pull out the pin, this measure has now been deemed inadequate and additional protective measures are requested by the BfArM.

The IFA examined various protective measures and existing protective concepts from the machinery sector and evaluated them based on whether they could also be used for height-adjustable tables. In some cases, existing protective equipment for machines was adapted so that it could be used on electrically operated height-adjustable tables. In order to assess the investigated protective equipment with regards to its effectiveness, a new assessment scheme was developed. This combines the potential hazards and accident scenarios in a matrix. The effectiveness of the respective protective measure can be individually determined using a scoring scheme.

A risk assessment template was also developed for companies that already have an electrically operated height-adjustable tables in use. This document can be downloaded free of charge from the IFA website. Furthermore, in cooperation with the Commission for Occupational Health and Safety and Standardisation (KAN), the German Social Accident Insurance Institution for health and welfare services (BGW), operators and manufacturers, an FAQ list was created with the most important questions related to this topic and the answers were agreed with the responsible state authorities. This FAQ list is also available on the IFA web page for "Safe therapy tables".

The gained experiences from the projects were directly incorporated into the standard DIN VDE V 0750-2-52-2:2021-10 (Particular requirements for basic safety and essential performance of couches) and were presented as part of the second KAN expert discussion. In addition, the BGW decided to launch a bonus program from mid-2022 for the retrofitting of tables or the purchase of new safe tables.

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