TissueSAFE
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The problem. Tissue transfer to pathology labs.

Get rid of formalin from the surgical theatre!The International Agency for Research on Cancer (IARC) has recently classified formaldehyde as a class 1 carcinogen.
This new classification is encouraging health authorities, surgical staff, pathologists and histotechnicians to look for ways to eliminate the substance from work environments. A critical exposure point for facility personnel is in the transfer of tissue from the surgical suite to the pathology lab. Current drawback:

  • Immersion into formalin prevents the collection of fresh material for tissue banking.
  • A delay in the transfer to pathology labs is somehow justified by the fact that “the tissue is already in formalin”.
  • Staff at the surgical theatre is increasingly concerned by the toxicity and cancerogenicity issues of formalin.
  • Plastic containers are large and relatively heavy. Spilling may occur.
  • In the pathology lab, container’s opening, extraction of  specimen and reduction of the latter constitute a major cause of diffusion of formaldehyde fumes.

The solution. TissueSAFE

With the TissueSAFE system it’s possible, for the first time, to monitor the time and temperature conditions of the biospecimen from the surgery theater to the laboratory.
Any abnormalities in the temperature of the specimens are documented and all appropriate steps can be taken.


Benefits for the patient care management team and...

Surgery suites
No more formalin fumes – No drying of tissues - No spilling
  1. Biospecimens, immediately after excision, are placed into empty, standard tissue containers and transferred to the pre-operating room where the TissueSAFE vacuum unit is installed. Specimens are placed into sterilized tissue bags and sealed under high vacuum by the TissueSAFE in 20 seconds. Small biopsies are placed in sealable caps for easy handling. Each bag is fitted with both an identification label and a sealable area for the requisition form.
  2. The vacuum sealed bag is placed in the basket of the transfer box, kept in a refrigerator and held within 0-4°C.
  3. A Radio Frequency Identification Device (RFID) smart card (optional), is placed into the transfer box to continuously monitor and document tissues temperature.

Surgery suites

Surgery suites

Surgery suites

Surgery suites

The benefits of TissueSAFE high vacuum sealing
  1. Autolytic process is slowed down by the absence of air.
  2. Faster cooling of tissues due to lack of insulating air.
  3. Preservation of real-life colors of specimens in absence of formalin.
  4. Drying of tissues is eliminated by high vacuum conditions.
  5. Specimens are held in “as fresh” conditions.
From the surgery suites to the pathology lab. Safe and lightweight.

At the required time, the transfer basket (with the RFID logger) is placed in a thermal insulated carriage fitted with chilling bags from the freezer of the refrigerator and transfered to the laboratory.
The biospecimens are maintained at temperatures between 0°C - 4°C.

Histology lab
Full documentationFull documentation
  • The RFID card is removed from the transfer box and read on a standard PC.
  • The time/temperature curve from the time of activation of the smart card until arrival in the lab is shown. If required, for documentation purposes, the log can be printed.
Preservation of morphology up to 64 hours
  • Studies have shown that specimens handled with the TissueSAFE technology are perfectly preserved for up to 48 - 64 hours and are ideal for morphological and molecular biology studies.
Grossing area
Improved work conditions
 

They can first be documented through a macro digital imaging system

They can first be documented through a macro digital imaging system (MacroPATH D)

Upon arrival bags are sequentially opened

Upon arrival bags are sequentially opened.
The tissues are fresh-like, with real-life colors.


After grossing, specimens can be resealed or placed in a closed formalin container.

Formalin fixation under controlled conditions? Yes
Selected blocks are inserted in cassettes for routine fixation in formalin and processing by either microwave or conventional protocols
Tissue banking? Yes
Selected blocks can be frozen for tissue banking
Ethanol based fixation for molecular studies? Yes
Specimen can be fixed in an ethanolbased molecular fixative (eg. FineFIX)
Pathologist's office
All tissues specimens

All types of tissues** have been preserved under vacuum (colon, gall bladder, spleen, kidney, thyroid, breast etc...) for up to 48-64 hours with optimal histological preservation.

Excellent H&E, HC, IHC, FISH staining properties.

Over thousand cases, using vacuum preservation, were tracked at the Molinette University Hospital in Turin, Italy. Morphological preservation and immunohistochemical reactivity were excellent and no adverse effects from the process were noted.

H&E IHC FISH
H&E IHC FISH
Adenocarcinoma of the colon. The specimen was kept under vacuum at 4°C for 48h, then routinely processed with formalin fixation and paraffin embedding. The structure is preserved and diagnosis is feasible. H&E x 150 Infiltrating ductal carcinoma of the breast. The tissuespecimen, removed on Friday afternoon, was kept under vacuum at 4°C till monday morning (64h), then routinely grossed, fixed and processed. The histological structure is well preserved. Staining for HER2 antigen (HerceptestTM by DAKO) shows a continuous membrane staining in >30% of cells (3+score). Infiltrating ductal carcinoma of the breast. Tissue specimen kept (at the surgical theatre) for 64h under vacuum, at 4°C. Dual-color FISH demonstrates amplification of HER2 gene (red signal).


The TissueSAFE system
 

TissueSAFE system
 
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