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Effective URL: https://www.milestonemedsrl.com/us/product/ultrasafe/?utm_campaign=periop_today&utm_medium=promotional&utm_source=email&utm_cont...
Submission: On June 29 via api from US — Scanned from DE
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</form>Text Content
MENUMENU
* Products
* * * Frozen Sections
* PrestoCHILL
* FineFIX Module
* PRESTO PRO
* FlashFREEZE
* * Cytology
* RoseSTATION
* * Specimen Handling
* UltraSAFE
* SealSAFE
* Labor and Delivery - TissueSAFE plus
* Grossing Devices
* * Tissue Processing
* MAGNUS
* PATHOS Delta
* EVO
* EVO One
* KOS
* HistosMATE
* Embedding Station HistoDream EW
* HistoDream Microtomes
* EasyCUT
* Auto-Embedding
* MileWATCH
* R-Tracker
* * Macro Digital
* MacroPATH
* MacroVIEW
* UltraGROSS
* eGROSS
* WorkSTATION
* HistoDream TS
* * Reagents
* Rack Cleaning Solution
* MCC
* FineFIX
* JFC Solution
* MoL-DECALCIFIER
* ProWAVE
* Services
* Application Advice
* Customer Support
* Inventing the Future
* True “Lean" Lab
* Tailor-Made Products
* Education
* CE Credits
* Publications
* Webinars
* About us
* Contact
* US Headquarters
* Worldwide Representatives
* Careers
* Products
* Frozen Sections
* PrestoCHILL
* FineFIX Module
* PRESTO PRO
* FlashFREEZE
* Cytology
* RoseSTATION
* Specimen Handling
* UltraSAFE
* SealSAFE
* Labor and Delivery – TissueSAFE plus
* Grossing Devices
* Tissue Processing
* MAGNUS
* PATHOS Delta
* EVO
* EVO One
* KOS
* HistosMATE
* Embedding Station HistoDream EW
* HistoDream Microtomes
* EasyCUT
* Auto-Embedding
* MileWATCH
* R-Tracker
* Macro Digital
* MacroPATH
* MacroVIEW
* UltraGROSS
* eGROSS
* WorkSTATION
* HistoDream TS
* Reagents
* Rack Cleaning Solution
* MCC
* FineFIX
* JFC Solution
* MoL-DECALCIFIER
* ProWAVE
* Services
* Application Advice
* Customer Support
* Inventing the Future
* True “Lean” Lab
* Tailor-Made Products
* Education
* CE Credits
* Publications
* Webinars
* About us
* Contact
* US Headquarters
* Worldwide Representatives
* Careers
Search
ULTRASAFE
Automated Formalin Dispensing System for Biospecimens
More Information Ask for a Virtual Demo
Sample Handling
THE PROBLEM
Formalin has been proven to be carcinogenic and detrimental to human
health. The International Agency for Research on Cancer (IARC) classifies
formaldehyde as a human carcinogen (1), and in 2011, the National Toxicology
Program named formaldehyde as a known human carcinogen (2). Additionally, the
US Occupational Safety and Health Administration (OSHA) has established limits
for the amount of formaldehyde that workers can be exposed to at their place of
work. Failure to establish effective protocols to limit exposure to formalin
could open up organizations to potential lawsuits.
THE SOLUTION
UltraSAFE is an innovative technology which allows operators in surgery rooms to
handle histology specimens in complete safety, with no exposure to fixative
fumes. This results in “Zero Formalin Exposure”. UltraSAFE revolutionizes OR
personnel safety by eliminating the risk of formaldehyde exposure. This enables
a healthier working environment where employees can complete their daily tasks
in a safer manner, without worrying about long-term health effects.
SAFE, AUTOMATED FORMALIN DISPENSING SYSTEM
UltraSAFE dispenses formalin based on specimen weight and individual lab
guidelines. This is carried out in an enclosed, safe chamber in a standardized
and documented manner. As a result, UltraSAFE dramatically reduces the potential
for formalin spills as well as reducing operator exposure to formalin fumes.
WHY ULTRASAFE?
* SAFETY
Fully automated and enclosed operation which prevents exposure to
carcinogenic formalin fumes. Utilizes dedicated buckets specifically designed
with a one-way, safety valve.
* STANDARDIZATION FOR HISTOLOGY
No longer receive unfilled buckets. Histology will always receive specimens
in buckets with the proper fixative ratio. Time to fixation is documented for
optimal processing and IHC results.
* TRACEABILITY
Documentation associated to the case with a 2D barcode for complete sample
traceability.
Read More
Need Automation, Standardization, and full Safety for specimen collection
transport & storage management? The UltraSAFE is the world’s first automatic
system that is the answer to all these questions. The UltraSAFE fills dedicated
containers, containing the bio-specimens, with the required fixative (i.e.
formalin) quantity, in a standardized and documented way with Zero Formalin
Exposure and no Formalin Spills.
Needle Biopsies are small and are fixed rapidly when placed in neutral buffered
formalin (4% formaldehyde), but larger surgical specimens require controlled
conditions and fixation. Nonetheless, lab administrators have to pay special
attention to limiting personnel exposure to the dangerous formaldehyde. Zero
Formalin Exposure is the goal. For the best outcomes, it is optimal for the
fixation process to be controlled by the operating room staff and pathology
laboratory. UltraSAFE can be used for specimen collection, transport & storage
with fixative and to achieve the goal of no formalin spills.
This innovative
specimen collection transport & storage technology, allows operators at surgery
rooms and at pathology laboratories, to handle histology specimens in full
safety. Today’s manual operation to prepare, transport and stock histology
specimens can be drastically improved with UltraSAFE technology.
The traditional
procedures of specimen collection, transport and archiving of pathology
specimens are specific at each institution. The introduction of UltraSAFE
technology at the starting point of sample generation (the surgery room),
pathology accessioning, and in the grossing area provides a dynamic and flexible
solution with benefits for all involved departments.
In the dirty room of a
surgery department, UltraSAFE is used to fix and seal biospecimens being
transported to the laboratory. The operator can select the desired procedure for
specimen management: filling the container with the appropriate volume of
fixative with zero formalin exposure and no formalin spills.
Large specimens
like stomach and bowel specimens are advised to be cut open to allow the
penetration of fixative.
Installing an UltraSAFE unit in the operating suite
enables maximum flexibility for specimen collection. In addition, UltraSAFE
dedicated buckets allow for multiple opening and sealing events. This can
accommodate pre-examination of large case specimen fixation/hardening; receipt,
grossing, and final storage of medium-sized specimens.
As specimens arrive into
pathology and are processed through accessioning, relevant data can be
downloaded and saved for future use. A detailed profile of duration of storage,
and additional specimen collection transport & storage information is viewable
and easily associated with patient cases.Why Zero Formalin Exposure is very
important to Operating Room Nurses?
In 2006, formaldehyde was declared Carcinogenic and Mutagenic to humans by
I.A.R.C. (International Agency for Research on Cancer). In today’s labs,
formaldehyde is the standard fixative for collecting and storing biospecimens
for pathological examinations and diagnoses. Operators, from operating rooms to
pathology departments, risk high levels of exposure to formaldehyde fumes.
Therefore, hospital and clinic safety departments are required to adopt
precautions to ensure the safety of their personnel.
Formaldehyde is known to be toxic and is classified as a category 1B carcinogen
and a significant association was demonstrated between formalin-fixation
procedures and the generation of oxidatively damaged DNA testified also by the
formation of the molecular adduct. This would justify its banning, as recently
proposed by EU authorities. Formaldehyde can induce increased levels of
oxidative stress and enhanced formation of ROS by different ways, including the
activation of oxidases and the inhibition of scavenger systems.
However, given
that to date a reagent able to guarantee the same performance in histopathology
is not available, a reasonable policy is to reduce the risk during specimen
collection transport & storage, by creating working conditions in which the
exposure of the personnel involved is limited to an acceptable minimum.
UltraSAFE is Milestone’s solution to formaldehyde reclassification. Using a
unique, patented technology, different sized buckets are automatically filled
with formalin in the “Dirty Room”, which
preserves the biospecimen in fixative right after the surgical excision. This
allows for total operator safety, assuring a formalin-free OR
environment.UltraSAFE bucket sizes and their technology:
UltraSAFE buckets are available in four standard sizes; 1, 3, 5 and 10 liters.
All buckets have, built-in to the lid, an exclusive quadricuspid valve. This
valve is specifically designed to prevent the escape of formalin fumes during
operation and, at the same time, allows for formalin dispensing using
UltraSAFE’s automatic filling. An additional cap attached to the valve seals the
bucket for extra safety during transportation. On the bucket’s lid, a unique 2D
barcode ensures biospecimen traceability. The UltraSAFE software can be used to
associate this 2D barcode with the biospecimen ID number for full patient
safety.UltraSAFE is the answer to the OSHA requirements:
The UltraSAFE system fulfills OSHA guidelines when it comes to formalin as it
provides Zero Formalin Exposure with no formalin spills.
The failure to properly train employees on hazardous chemicals such as
formaldehyde is the second most frequently cited violation in healthcare
facilities across the U.S. In fact, fines as much as $112,000 have been issued
by The Occupational Safety and Health Administration (OSHA) to healthcare
facilities for the failure to provide employees with the proper formaldehyde
training and monitoring.
What is formaldehyde?
Formaldehyde is a potent, colorless gas that is commonly used in hospitals,
medical laboratories, dental offices, and pediatric practices as a preservative,
sterilizer, and disinfectant. It is also used for manufacturing purposes,
funeral homes for embalming, and is found in a number of household products such
as paper towels, shampoo, deodorant, toothpaste, lipstick, nail polish, and
glue.
What are the risks associated with exposure to formaldehyde?
Exposure to high levels of formaldehyde should be avoided if possible, as it may
trigger severe allergic reactions such as difficulty breathing, asthma attacks,
respiratory irritation, headaches, watery/burning eyes. Formaldehyde is a skin
irritant, a cancer-causing agent, and if ingested can be fatal. According to the
Department of Health and Human Services (DHHS), formaldehyde may “reasonably be
anticipated to be a carcinogen.”
What should employers know about formaldehyde?
The OSHA Formaldehyde standard (29 CFR 1910.1048) protects workers exposed to
formaldehyde.
• The permissible exposure limit (PEL) for formaldehyde in the workplace is 0.75
parts formaldehyde per million parts of air (0.75 ppm) measured as an 8-hour
time-weighted average (TWA).
• The standard includes a second PEL in the form of a short-term exposure limit
(STEL) of 2 ppm, which is the maximum exposure allowed during a 15-minute
period.
• The action level – which is the standard’s trigger for increased industrial
hygiene monitoring and initiation of worker medical surveillance – is 0.5 ppm
when calculated as an 8-hour TWA.
What must employers do to protect workers from formaldehyde exposure?
OSHA has very specific regulations on the monitoring, training and protection of
workers who are exposed to formaldehyde. Some key provisions of the OSHA
standard require employers to do the following:
• Identify all workers who may be exposed to formaldehyde at or above the action
level or STEL and determine their exposure. Reassign workers who have
significant adverse effects from formaldehyde exposure to jobs with
significantly less or no exposure until their condition improves. Reassignment
may continue for up to 6 months until the worker is determined to be able to
return to the original job or to be unable to return to work – whichever comes
first.
• Implement feasible engineering and work practice controls to reduce and
maintain worker exposure to formaldehyde at or below the 8-hour TWA and the
STEL. If these controls cannot reduce exposure to or below the PELs, employers
must provide workers with respirators.
• Label all mixtures or solutions composed of greater than 0.1 percent
formaldehyde and materials capable of releasing formaldehyde into the air at
concentrations reaching or exceeding 0.1 ppm. For all materials capable of
releasing formaldehyde at levels above 0.5 ppm during normal use, the label must
contain the words “potential cancer hazard.”
• Train all workers exposed to formaldehyde concentrations of 0.1 ppm or greater
at the time of initial job assignment and whenever a new exposure to
formaldehyde is introduced into the work area. Repeat training annually.
• Select, provide and maintain appropriate personal protective equipment (PPE).
Ensure that workers use PPE such as impervious clothing, gloves, aprons, and
chemical splash goggles to prevent skin and eye contact with formaldehyde.
• Provide showers and eyewash stations if splashing is likely.
• Provide medical surveillance for all workers exposed to formaldehyde at
concentrations at or above the action level or exceeding the STEL, for those who
develop signs and symptoms of overexposure — and for all workers exposed to
formaldehyde in emergencies.
Recordkeeping Requirements
Employers are required to do the following regarding worker exposure records:
• Retain exposure records for 30 years.
• Retain medical records for 30 years after employment ends.
• Allow access to medical and exposure records to current and former workers or
their designated representatives upon request.
According to OSHA, medical facilities must train employees on hazardous
substances such as formaldehyde. There are many safety hazards in hospitals and
medical facilities from bloodborne pathogens and biological hazards to chemical
and drug exposures, waste anesthetic gas exposures, needle-sticks, radioactive
material, and more. Taking the proper precautions, implementing preventative
measures, and providing employee training to ensure a safe work environment for
all employee’s is an employer’s responsibility that should always be a top
priority.
Mandy Martin, RPSGT, is a compliance consultant at MedSafe.
1 Top 10 Most Frequently Cited Standards. (n.d.)
https://www.osha.gov/Top_Ten_Standards.html
2 OSHA Fact Sheet: Formaldehyde. (n.d.).
https://www.osha.gov/OshDoc/data_General_Facts/formaldehyde-factsheet.html
Formaldehyde Spill Protocol for Laboratory Personnel
The Occupational Safety and Health Administration (OSHA) requires employers to
have a written program for the safe use of formaldehyde containing materials.
The University of Rochester’s written Formaldehyde Program was written to comply
with this standard and provide the necessary actions to protect laboratory
personnel. A copy of the written program is available at the University’s
Environmental Health and Safety’s web site.
Formaldehyde solutions can be found in a number of University laboratories. The
concentration of these solutions is typically 3.7% formaldehyde (commonly called
10% formalin). However, some laboratories purchase 35-37% formaldehyde
solutions. The higher concentration presents a challenge in minimizing exposures
when handling and cleaning up spills. Paraformaldehyde and formalin are to be
handled in the same manner as formaldehyde.
This document deals with the cleanup of minor spills of formaldehyde containing
materials. Major spills need to be handled as stated in the University of
Rochester’s EMERGENCY 13 flip chart and called into Public Safety (x13) for an
EH&S Spill Team response.
Possible Health Hazards/Precautions
The most likely exposures for lab personnel during a spill are from inhalation
and from direct skin or eye exposures. Because minor spills can be cleaned up
quickly, inhalation exposures must not exceed the OSHA Short Term Exposure Limit
of 2.0 parts per million for 15 minutes.
To minimize exposures, appropriate PPE must be worn at all times when handling
any formaldehyde solution, including cleaning up minor spills. The PPE would
include a lab coat, disposable gloves, and safety glasses or goggles. Personnel
can elect to wear additional PPE, such as double gloves.
Minor Spill Protocol
Minor spills are those that can be cleaned up very quickly by laboratory
personnel who have received training on the hazards of formaldehyde. The
quantity, concentration, the location of the spill, and the availability of
staff to assist in the cleanup may elevate some formaldehyde spills to the
status of a major spill. The table below illustrates some spill scenarios: Minor
Spills Major Spills A single leaking specimen container containing 10% formalin
or paraformaldehyde Multiple broken specimen containers that contained 10%
formalin (perhaps from a collapse of a shelf). A broken specimen container that
contained up to 100 ml of 10% formalin or paraformaldehyde A partial or full
container containing more than 100 ml of 35% formaldehyde onto a bench or the
floor A partial of full container (greater than 100 ml) of 35% formaldehyde in a
chemical fume hood A stock bottle (500 ml or greater) of 10% formalin onto a
bench or the floor A splash of concentrated formaldehyde or paraformaldehyde
onto a surface A single lab staff member who becomes injured and drops 1-2
specimen containers
Immediate action must be taken to prevent an over-exposure to formaldehyde
should a container fail or leak. The following are actions to take for certain
MINOR SPILL situations that may
occur. For any spill response, always wear the required PPE. If you are
uncertain about a certain spill or situation, leave the immediate area and call
Public Safety (x13) and request the University’s EH&S Spill Team.
For small/minor formaldehyde spills, clean surfaces with cold water at least two
times. If paper towels are used, place the used towels into a plastic bag and
seal the bag. Use CHEMATIX to complete a waste tag so the material is disposed
of as hazardous waste.
Some suggested clean up procedures to use that will minimize potential exposures
to formaldehyde are listed below.
1. A SINGLE leaking, unused (new) sample container (less than 100 ml): Place a
paper towel under the leaking container (to prevent dripping the aldehyde onto
the floor and other surfaces) and take the specimen container to a sink. Pour
the aldehyde solution from the leaking container into a hazardous waste
container. Clean any contaminated surface with cold water at least two times.
Take all paper towels contaminated with the aldehyde and place into a sealable
bag for disposal as hazardous waste.
2. Leaking specimen container holding a specimen: Transfer the specimen into
another specimen container. Pour the aldehyde solution from the leaking
container into a waste container for disposal as hazardous waste. Clean any
aldehyde contaminated surface as listed in #1 above.
3. A splash of concentrated formaldehyde or paraformaldehyde: Wipe up the splash
with paper towels and place the paper towels into a fume hood to minimize
inhalation exposures. Clean any contaminated surface with cold water at least
two times. Place the aldehyde contaminated paper towels into a sealable bag for
disposal as hazardous waste.
4. Making formaldehyde containing solutions: Potential over-exposures can occur
when preparing paraformaldehyde and 35% formaldehyde solutions. Such solutions
need to be prepared in chemical fume hood to prevent exposures and to contain
spills. If a spill occurs within the fume hood, the spill can be considered
minor and can be cleaned up using paper towels. Clean any contaminated surface
with cold water at least two times. Place the aldehyde contaminated paper towels
into a sealable bag for disposal as hazardous waste.
If an bottle (greater than 100 ml) of 35% formaldehyde or paraformaldehyde were
to break on a counter or the floor, or multiple sample containers break and the
formaldehyde is observed to be scattered onto or around multiple other items
resulting in an extended cleanup, evacuate the location and follow the
information outlined in the University of Rochester Medical Center’s EMERGENCY
13 flip chart, section listed Chemical/Biological/Radiological Spill.
If you have any questions or concerns about the storage or use of formaldehyde
or any other chemical in your work area, please contact the EH&S’s Laboratory
Safety Unit at x5-3241.Milestone’s collection and transportation technology is a
proven solution to formalin exposure:
The adoption of the Milestone’s collection and transportation technology for
surgical specimens transported to the laboratory results in a sharp decline in
the exposure of nurses to formaldehyde. In fact, evidence of the reduction of
oxidative stress in nurses adopting the Milestone’s collection and
transportation technology in alternative to the use of open formaldehyde
procedures in operating theatres was given. This data adds to the already
acquired experience on the advantages offered by the UltraSAFE system procedure
in specimen collection, in terms of improved tissue preservation for diagnosis
and research, and appreciation of the operational feasibility of the process, by
the nursing staff.
With UltarSAFE Milestone offers an innovative, scientific publications proved
method for a better and safer specimen collection transport & storage.
In the
Operation Theatre site, nurses or surgeons’ assistant dispense formalin onto
specimens in an automated way, standardized and tissue are ready to be
transported to the laboratory in containers with the proper amount of fixative.
Due to the UltraSAFE sealed environment there is zero formalin exposure and no
formalin spills at the time of filling the buckets.
Formalin spills will result in increasing the surface area of the formalin.
Formalin gas evaporation depends more on square surface area than the volume of
formalin spilled. This means a small spill can result in a higher exposure than
normally occurs under normal handling. Exposure levels of exceeding the
short-term exposure limit of 2ppm for a 15 -minute exposure can easily occur
with comparatively small volumes requiring clean up by trained personnel and
evacuation of patients and staff while clean up occurs.In conclusion:
The value of UltraSAFE to both Histology and Surgical staff is an effective and
immediate solution to address and reduce formalin exposure.Additional technology
that you might be interested in reading about from Milestone:
SealSAFE and TissueSAFE Vacuum sealing option:
SealSAFE is the world’s first automatic system that fills dedicated bags
containing biospecimens with the required fixative (i.e. formalin) in a
standardized and documented way.
This innovative and patented technology allows
operators in surgery rooms and in pathology laboratories to handle histology
specimens in complete safety. SealSAFE vacuum seals biospecimens along with the
correct amount of formalin and allows for the safest transportation method for
biospecimens, ensure zero formalin exposure and no spills.
Publications cite the preservation of Nucleic acid in Vacuum sealed surgical
pathology specimens. The numerous experimental and clinical studies of
formaldehyde exposure have convinced governmental organizations and
institutional facilities to implement measures for monitoring formaldehyde
exposure. While there are calls to restrict or even eliminate use of
formaldehyde use, the value of formaldehyde as the universal fixative in
anatomic pathology suggests that it will continue to be in use for the immediate
future.How can we have zero formalin exposure also with formalin pre-filled
containers?
An additional source of exposure to formaldehyde is pre-filled vials for fixing
small biopsies, since in fact this procedure is carried out in all types of
surgical theatres. While the bulk of exposure is related to the habit of pouring
liquid formaldehyde (3-5 liters at a time) in large containers, still a residual
risk of exposure is posed by formalin pre-filled containers.
Milestone has developed FormSAFE to addressed also the pre-filled containers
formalin exposure risk.
FormSAFE provides an excellent alternative to traditional prefilled containers
when personnel are concerned with formalin exposure during collection, transport
and storage. A second stratified fluid component floats above the formalin phase
and acts as a protective floating shield, which prevents fixative fumes from
escaping from the container. This concept of a multi-layered liquid container
allows safe handling both to the endoscopist at sampling and to the histologist
when preparing the cassette. The endoscopist can easily detach the specimen from
the tweezers by immersing them in the liquid without being exposed to formalin
vapors. The histologist can open the container and pick up the specimen without
being exposed to the fumes.
See UltraSAFE in action!
Automated Formalin Dispensing System for Biospecimens: how it works!
Discover the innovative Bucket Technology
ULTRASAFE BUCKETS
* Dedicated buckets and lids which are equipped with built-in, one-way valves
to prevent operator exposure to carcinogenic formalin fumes
* Laser engraved, unique bucket ID for full traceability
* Buckets available in 1, 3 or 5 liter capacities
* Patent applied for
References:
1. International Agency for Research on Cancer (June 2004). IARC Monographs on
the Evaluation of Carcinogenic Risks to Humans Volume 88 (2006):
Formaldehyde, 2-Butoxyethanol and 1-tert-Butoxypropan-2-ol. Retrieved June
10, 2011, from: http://monographs.iarc.fr/ENG/Monographs/vol88/index.phpExit
Disclaimer.
2. National Toxicology Program (June 2011). Report on Carcinogens, Twelfth
Edition. Department of Health and Human Services, Public Health Service,
National Toxicology Program. Retrieved June 10, 2011, from:
http://ntp.niehs.nih.gov/go/roc12.
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