Summary and conclusions

REACH på hospitalet

The purpose of this project was to examine how the new chemicals regulation - REACH - can affect hospitals.

REACH covers all chemical manufacturers and users - including hospitals. With hospitals primarily being end-users of chemicals, they only have a limited number of obligations in relation to REACH.

Generally, the hospitals participating in this project have a good overview of the chemicals they are using, which means that their primary challenge is to adapt their existing routines and systems to the new requirements of REACH. Furthermore, they need to ensure that the chemicals currently used also can be used in connection with REACH. Several substances that may become subject to authorization were identified, including substances used in diagnostic and quality control work. In addition, a large number of chemicals are likely to require an exposure scenario. In these situations, the hospitals must ensure that their use is covered by an exposure scenario.

Through three completed cases, features of the practical handling of the REACH requirements have been studied. These cases focused on purchase, communication and future security of supplies.

A number of elements in the process of implementing REACH in the hospitals will be centered around the purchase of chemicals. It is recommended that a REACH knowledgeable person is involved in the preparation of standard phrases to the specification requirements in order to avoid import of chemical substances from outside the EU - thus avoiding importer status and registration requirement – as well as to avoid purchases of substances subject to authorization. It is recommended that the hospital units and departments use the agreements concluded by Koncern Indkøb. It is recommended that the same REACH conditions are imposed at purchases of any soloist goods.

A number of user groups for different product groups are already established across hospitals in the Capital Region (Hovedstadsregionen) and new user groups are established when needed. A user group is established for a given product group, for example cleaning agents, and its members are representatives for the relevant users of the product group. To include user groups - assisting in the formulation of the requirements to be made by contract - are therefore highly relevant. The strategic acquisition, i.e. conclusion of agreements with suppliers, is conducted in close cooperation between Koncern Indkøb and the user groups.

For chemicals requiring an exposure scenario, hospitals must ensure that their use is covered by an exposure scenario. For this the hospitals must describe how the chemical is used, thus enabling the supplier to prepare an exposure scenario. Subsequently, the hospitals need to ensure that the requirements of the received exposure scenarios are observed. This is done most conveniently by an adaptation of the workplace instructions (APBer), which are used routinely in the hospitals.

It may turn out that a supplier does not want to cover the hospitals use. In this case, the hospital may consider making its own chemical safety (CSA) and documenting the CSA in a downstream user chemical safety report (CSR), including an exposure scenario. This will require training of the hospital staff to perform the task or use of consultancy.

For the substances requiring an authorization, the hospital may initially try to get these substituted. If this is not possible, the hospital should try to get their supplier to apply for an authorization. If substitution is not possible and the supplier will not help with the application, then the hospital needs to prepare an application for authorization. As probably many other hospitals in both the US and the EU apply the same use of the substances, the opportunity to develop a joint application with other hospitals - both in and outside of Denmark, exists and should be explored.

The future security of supplies for a number of selected critical substances was evaluated in two of the cases. For some of the substances, the future security of supplies was assessed to be low, as apparently only very few manufacturers of these particular substances exist worldwide. In fact for some of the substances, the hospitals have already experienced transient problems with delivery. Hospitals should review their chemicals and identify those that are highly critical to their daily work and subsequently assess the future security supply of these. Opportunities for alternatives should also be explored. Case 3 illustrates one way of carrying out these assessments.

Through the development of workplace instructions (APBer), generally well-functioning working procedures ensuring the necessary internal communications around chemicals in the hospitals already exist today. The additional requirements on internal communication imposed by REACH can probably fairly easy be adapted to the existing communication routines. To ensure a proper implementation of REACH and the necessary chemical related communication about REACH, it would be appropriate with a briefing of relevant staff - including department managers - about the hospitals REACH requirements and challenges and to inform on how the hospital will handle the challenges.

In future, REACH will require an extended communication between chemical suppliers and the hospitals - especially around the uses. The main conclusion from the initial communication with suppliers, which took place in this project was, that it was still too early to start a very structured dialogue about the uses and the like, as suppliers cannot make any guarantees about future supplies. Nevertheless, the hospitals ought to prepare themselves to lead the dialogue and to face a situation where some of the previously used chemicals may no longer be available for their use.

As the hospitals can be expected to have the similar challenges with REACH, it is obvious - if possible - to seek common solutions to these challenges. In particular, this project has identified the following tasks, which with great advantage can be solved by cooperation across hospitals:

Formulation of common requirements for the procurement of chemicals
Development of a uniform way to characterize the hospital uses of chemicals
Common system for the implementation of exposure scenarios
Common chemicals management
Joint application for authorisation of particular hazardous substances