Kem Medical Products retains all analytical reports for 30 years. The results have daily backups and are also kept off-site by remote access.

Have the ventilation system inspected. There could be impedance in the ventilation system causing a reduction of the air flow. Due diligence is recommended to ensure that the ventilation delivers enough room air changes as needed throughout the year for a given area. It could also be indicative of careless personnel techniques.

Yes. The Federal Occupational Safety and Health Administration (OSHA) has a regulation which requires that all employers who use formaldehyde, regardless of the quantity used, monitor their employees to prove that exposures are not above the Federal Exposure Standards.

The formaldehyde concentration levels for your employees must be lower than 0.75 ppm for an 8-hour TWA, lower than 0.5 ppm for the Action Level, and lower than 2.0 ppm for a 15-minute (or less) TWA (STEL). STEL or 15 minute monitoring should be thought of as related to job tasks where there is potential for elevated exposure.

Kem Medical Products provides validated passive dosimeters specific for formaldehyde, catalog #8510. You may monitor each potentially exposed employee, or choose representative worst case employees from each shift, work station or job classification. To monitor an employee’s 8 hour exposure, the employee should wear the badge during his/her entire workday. To measure the 15 minute STEL, the employee should wear a badge during the entire job task, but not to exceed 15 minutes.

Yes. An agency may request proof of compliance that formaldehyde levels were lower than the OSHA Standards. Retain your Kem Medical Laboratory Analysis Reports as proof of OSHA compliance.

If an over-exposure occurs, you must endeavor to correct the situation, and you must monitor at least quarterly, until you can demonstrate the situation has been corrected.

No, real-time monitors give an instantaneous value, whereas passive monitors sample the environment over time. This gives a true representation of the workplace environment for an 8-hour day or a 15-minutes task when the concentration values could be at its highest level.

Passive sampling allows a worker to move his position and his total exposure is a summation of those from different points in space and time. The optimum strategy of a workplace exposure profile is a combination of personal task related duties and supplemented by fixed location sampling, the latter needed to identify high concentrations areas and to target those processes requiring improvements.

The Kem Medical badge is validated for a 15-minute STEL time period up to a 2×PEL time period. Therefore, one badge can detect either time period. Both the 15-minute STEL and 8-hour PEL should be conducted to fully assess occupational exposure.

Formaldehyde is a carcinogen, employees should wear a full face shield, chemical splash-proof goggles and formaldehyde impervious gowns, and gloves, such as neoprene or butyl plus, when working with formalin, as per OSHA 29 CFR§1910.1048.

Yes, the efficacy of the neutralizer in conjunction with the sterilant was independently verified on both glutaraldehyde and OPA at >99.9%. The Fish Toxicity study conducted by an independent laboratory in California verifies that the neutralizer combined with the glutaraldehyde or OPA can be safely disposed into the sewer system.

A disadvantage of using OPA is that it stains proteins gray, including unprotected skin and thus must be handled with caution The protein present on the instruments reacts with OPA and may cause pitting of the instrument, as well. The Kem Medical neutralizer prevents the OPA from continuing to mar the instruments.

Surface tension is broken during disposal allowing for vapors to be released into the air. In addition to neutralizing before disposal, sinks should be thoroughly flushed with cold water after glutaraldehyde disposal and soaking vessels should be properly labeled and covered at all times to minimize exposure.

Glutaraldehyde monitoring badges are used to determine any exposures, as well as glutaraldehyde impervious gowns, full face shields, chemical splash-proof goggles, and gloves. If disposable respirators are used, then all personnel involved must follow the OSHA required respiratory program, under 29CFR 1910.134.

For areas in which potentially harmful vapors are present, such as glutaraldehyde, a negative air exchange rate of at least ten (10) complete exhaust room air changes per hour is recommended by ASHRAE, NIOSH and AAMI. 

Yes, the Kem Medical Neutralizing products for glutaraldehyde and OPA use glycine as the active neutralizing chemical. In 2000, California law makers passed Senate Bill - No. 2035. This allows medical facilities to treat and dispose of used glutaraldehyde and OPA without a permit, providing that: The sole active chemical of the neutralizing solution is glycine. The waste is generated by a medical facility during the disinfection of medical devices. The waste is treated at the site where it was generated.

Eliminate toxic vapors created during disposal of waste solution. Will not stain soaking containers, sinks, etc. Prevents black staining from OPA use. Neutralization is complete within 5 minutes and solution is ready for safe disposal. Color change occurs during neutralization. Safe for use in automatic scope washers.

The concentration level of 0.2 ppm should not be exceeded. ACGIH has a recommendation of less than 0.05 ppm.

Yes. The Federal Occupational Safety and Health Administration (OSHA) has a regulation, 1910.1047 Occupational Exposure to Ethylene Oxide, that requires that all employers who use ethylene oxide monitor their employees to prove that exposures are not above the Federal Exposure Standards.

The ethylene oxide concentration levels for your employees must be lower than 1.0 ppm for an 8-hour TWA, lower than 5 ppm for the Action Level, and lower than 5.0 ppm for a 15-minute TWA.

Kem Medical Products provides validated passive dosimeters specific for ethylene oxide, catalog #8500. Monitoring, should be conducted when ethylene oxide exposure is most likely (e.g. loading and unloading EO sterilizers, removing the BI from test pack, loading and unloading separate mechanical aerators, tank changes, maintenance, etc.).

Yes. An agency may request proof of compliance that ethylene oxide levels were lower than the OSHA Standards. Retain your Kem Medical Laboratory Analysis Reports as proof of OSHA compliance.

If an over-exposure occurs, you must endeavor to correct the situation, and you must monitor at least quarterly, until you can demonstrate the situation has been corrected.

Yes. OSHA requires that you have a system to immediately alert your employees to an emergency condition. OSHA has further concluded that the only practical means to achieve this is a wall-mounted 24/7 electronic real-time EO Gas Alarm Monitor..

Yes. The Federal Occupational Safety and Health Administration (OSHA) can enforce exposure limits as recommended by the National Institute for Occupational Safety and Health (NIOSH), the American Conference of Governmental Industrial Hygienists (ACGIH), and as listed in the OSHA Air Contaminants Standard. These recommendations for exposure limits can be enforced under OSHA’s General Duty Clause, which essentially means that each employer has a general duty to provide a safe workplace that is free from recognized hazards.

The xylene concentration levels for your environment must be lower than 100 ppm for an 8-hour TWA and lower than 150 ppm for a 15-minute TWA.

Kem Medical Products provides validated passive dosimeters specific for xylene, catalog # 8540. Monitoring should be conducted when xylene exposure is likely (e.g. cover-slipping, employees in close proximity while processing items with xylene, and in treating xylene spills.).

Yes. An agency may request proof of compliance that xylene levels were lower than the OSHA Standards. Retain your Kem Medical Laboratory Analysis Reports as proof of OSHA compliance.

If an over-exposure occurs, you must endeavor to correct the situation, and you must monitor at least quarterly, until you can demonstrate the situation has been corrected.