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On January 1st 2016, formaldehyde was reclassified as a Category 1B carcinogen and Category 2 mutagen under the CLP (Classification, Labelling and Packaging) Regulations EC 1272/2008.

Category 1B substances are presumed to have carcinogenic potential for humans. Therefore under COSHH there is a duty on employers to reduce exposure to such substances to as low a level as is reasonably practicable.

Formalin has been widely used as a tissue fixative for many years and cannot be completely replaced from histological diagnostic procedures.  However, in view of the reclassification there is an increased need to consider user safety.  The Health and Safety Executive have reiterated that it is the responsibility of the duty holder to revisit their current COSHH risk assessment and existing control measures for formalin and to consider what else is required to comply with the COSHH legislation.

The TissueSAFE and SealSAFE from Menarini Diagnostics provide a sound alternative to traditional methods of collecting and transporting specimens in buckets of formalin.  The use of these systems dramatically reduces formalin exposure and the handling of bulk chemicals, both in theatres and pathology laboratories.

  • TissueSAFE vacuum seals specimens in bags, without formalin, thereby dramatically reducing the use of formalin in theatres.  This improves safety for patients, theatre staff, porters and delivery drivers.  It also allows fixation to be brought under the control of the histology laboratory, making it a real science.
  • SealSAFE vacuum seals specimens and controls the amount of formalin dispensed into the bag according to the specimen weight within a closed unit for maximum safety, efficiency, quality and standardisation.  This improves safety for histology staff and pathologists.


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