UltraSAFE is a stand-alone automated fixative filler for buckets. It doses the required fixative (i.e. formalin) in a standardized and documented way, in full safety and granting a spillage proof buckets’ closure. This innovative and patented technology allows operators in surgery rooms and in pathology laboratories to handle histology specimens in complete safety, with no exposure to fixative fumes.
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.
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 UltraSAFE 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.
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.