March 9, 2010
Ms. Janet Peterson, CRNP
1326 Princess Ave.
Pittsburgh, PA 15216
Dear Ms. Peterson:
Thank you for your November 14, 2009, letter to the Occupational Safety and Health Administration (OSHA). Your letter has been referred to OSHA's Directorate of Enforcement Programs for a response. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any questions not detailed within your original correspondence. You expressed concerns regarding decontamination of patient examination tables in an outpatient hospital clinical setting. Your paraphrased scenario and our response are presented below.
Scenario: Your letter stated that you are employed at a hospital-based outpatient clinic where patients are treated for sleep disorders. Between patients, your clinic requires patient exam tables to be disinfected with a cleaning product that you identified as Pedi Wipes. You stated you have experienced allergic reactions to the Pedi Wipes used for decontamination, so you have suggested your clinic allow you to instead use soap and water to clean the patient exam tables, as long as the patients are not infectious. Your employer has not adopted your suggestion, and now you believe you are in danger of losing your job. Therefore, you have requested a letter from OSHA stating that cleaning examination tables with soap and water is in compliance.
Response: OSHA's Bloodborne pathogens standard at 29 CFR 1910.1030 requires that items and surfaces contaminated with blood or other potentially infectious materials (OPIM) be decontaminated with an appropriate disinfectant. Additionally, decontamination of examination tables between patients is an infection control (IC) issue which is out of OSHA's jurisdiction. Hospitals following guidance from the Centers for Disease Control (CDC) can implement more stringent control measures. The U.S. Environmental Protection Agency (EPA) is the governmental agency which determines the appropriateness of disinfectants. The EPA is responsible for overseeing the registration of sterilants, tuberculocidal disinfectants, and other anti-microbial products. EPA-registered tuberculocidal disinfectants and solutions of 5.25% sodium hypochlorite (household bleach) diluted between 1:10 and 1:100 with water are considered appropriate for this purpose. While soap and water may be appropriate for general cleaning purposes, it is not appropriate for decontamination of blood or OPIM.
Please be aware that under OSHA's Hazard Communication standard at 29 CFR 1910.1200, employers are required to maintain material safety data sheets (MSDSs), provide training and the appropriate personal protective equipment (PPE) for all chemicals that pose a health hazard to their employees. Disinfectants such as the Pedi Wipes you described, most often, contain alcohols which can cause irritation to the eyes and lungs.
In addition to investigating safety and health complaints, OSHA under Section 11(c) of the OSH Act, has authority to investigate complaints of retaliation when an employee believes adverse action has been taken against him in reprisal for filing a safety or health complaint with OSHA or raised concerns about workplace safety and health to his employer. The filing deadline is 30 days from the adverse action, so if you are interested in filing a complaint you should contact your local OSHA area office for further information as soon as possible at:
Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA's requirements are set by statute, standards and regulations. Our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Enforcement at (202) 693-2190.
Sincerely,
Richard E. Fairfax, Director
Directorate of Enforcement Programs
Used on immersible items such as flexible endoscopes.
Most common formulation in use today is Cidex.
Intended for use in the high-level disinfection of semi-critical and critical medical devices.
Should never be used as environmental disinfectants.
Is not a cleaning agent. Thorough cleaning with a detergent followed by rinsing is required to ensure the effectiveness of the process.
2% solutions at 77F are effective against all vegetative bacteria, mycobacteria, and viruses.
Available in both acidic and alkaline preparations. Glutaraldehyde have a limited use life of 14 to 28 days after activation.
Items to be immersed in a solution must be completely dry.
Soaking time necessary to achieve high-level disinfection is 45 minutes kills up to Mycobacterium TB level.
Ability to kill spores when used for extended exposure times, 8-12 hours (classified as a liquid chemical sterilant) - kills up to spore level.
Glutaraldehyde residuals in products can be extremely toxic and, if an item is not thoroughly rinsed after immersion, can cause sloughing of any tissue with which it comes in contact.
Manufacturers of Glutaraldehyde products recommend that disinfected items be rinsed at least twice, with fresh rinse water each time.
Recontamination of devices by the rinse water is a concern; therefore, if practical, sterile or purified water should be used for rinsing.
Glutaraldehyde fumes irritate the respiratory tract and have been known to cause adverse reactions, including respiratory arrest, in sensitized individuals. To minimize employee exposure solutions must be used in a well-ventilated area and covered during use and storage.
Vents should be located at the point of discharge, because the fumes are heavier then air, at floor level.
Odors emitted by Glutaraldehyde can be detected at levels of 0.4 (ppm) in the air.
The American Conference of Governmental Industrial Hygienists (ACGIH), a private professional organization whose recommended occupational exposure limits for many potentially toxic chemicals are widely recognized, has established a "ceiling threshold limit value" (TLV-C) of 0.05 ppm.
Routine monitoring of employees is required to ensure that the ceiling limit is not exceeded at any time during work shifts.
Records of all testing must be maintained by the institution, and employees must be advised of the test results.
Exhaust hood should be connected directly to a non-recirculating exhaust system that discharges directly to the outside of the building, or there must be a self-contained system with collection devices or media.
Additional precautions associated with Glutaraldehyde, include the implementation of a spill plan, routine disposal procedures, and a documented training program.
The spill plan addresses how to handle solution dripping on to work surfaces when items are removed from the solution for rinsing and how to handle a larger spill.
Commercially available mats are available for control of the minor spills (drips).
Larger spills can be neutralized with household ammonia or other commercially available solutions. Pillows or dams can also be used.