><
>14. The Respondent maintains written policies concerning the handling, preparation and disposal of Renalin as well as the air level monitoring of its components.[18] It also has written policies governing operation of the Renatron machines and the reprocessing of dializers.[19] The policies are posted in the reuse room.[2 Employees are required to review the policies as well as the material safety data sheets.[21] Material safety data sheets are maintained near the nurses? station in the dialysis unit.[22] Respondent?s in-service training includes discussion of the right to know laws,[23] and general safety rules.[24]<
><
>15. When the respondent began using Renalin in its Duluth unit in 1992, its employees, including Ms. Scott, were provided in-service training by a representative of Minntech. During the training employees were instructed in how to use and handle Renalin including its purpose, how to mix it, how to use it in dializers and dialysis machines and how to clean up spills.[25] During the training the Minntech representative was asked whether it was safe to expose pregnant women to Renalin. He replied that Renalin was very safe, that you could practically drink it, and that there was no indication that it posed problems during pregnancy.[26]<
><
>16. The tasks which most directly involved Ms. Scott with Renalin occurred in the reuse room where the dializers were reprocessed or cleaned and sterilized by rinsing out residual blood and putting a Renalin solution into the dializer. The Duluth dialysis unit ran three Renatron machines which cleaned the dializers. Ms. Scott would remove the lines from the dializer and rinse them in the sink and then attach the dializers to the Renatron machine. The Renatron machine reprocessed the dializer in approximately eight minutes. Once the reprocessing was done Ms. Scott would detach the dializers from the Renatron machines by removing the connecting lines, placing clean port caps on the dializers and wiping the dializers down with a 1% Renalin solution. The dializers were then placed on the counter to be labeled. After they were labeled, Ms. Scott would put them away in the dializer storage room.[27]<
><
>17. Certain steps in the dialyzing reprocessing caused Ms. Scott discomfort because of exposure to Renalin that caused her eyes to water, her nose to burn and her throat to become sore. The Renatron machines used a 20% Renalin solution which was drawn into the machine through hoses attached to jugs stored in a cabinet under the machines. One step that caused Ms. Scott discomfort occurred when she needed to switch hoses from an empty jug to a full one and needed to dump the 20% Renalin solution from the old jug into the sink.[28] Another task that caused discomfort occurred because Ms. Scott was responsible for mixing a 20% Renalin solution. This was accomplished by placing two and one-half gallon jugs containing two liters of 100% Renalin on a cart under a vented Plexiglas awning and filling the jugs with RO water and mixing for 30 seconds.[29]<
><
>18. Additionally, each Saturday afternoon Ms. Scott would complete an ?end to end? disinfect of all of the dialysis machines in the patient treatment room. To accomplish this task Ms. Scott needed to fill 14 to 16 empty two and one-half gallon Renalin jugs with eight liters of RO water and 80 milliliters of 100% Renalin. She would cap the jugs, mix them and then check the solution with a dip stick to insure that the concentration of Renalin was adequate. It took Ms. Scott approximately 20 minutes to mix the 14 to 16 jugs. She would sometimes have to leave the reuse room because her throat would burn, her nose would burn and sting, her eyes would water and she would have difficulty
eathing.[3 Ms. Scott would then take the jugs to the treatment room and run the Renalin solution through the dialysis machines. She was exposed to Renalin and caused discomfort when she dropped the hoses from the dialysis machine into the jugs of Renalin solution and when she dumped the remaining Renalin solution in the sink after completing the task.[31] The entire ??end to end? process took approximately an hour and one-half to two hours.<
><
>19. A program for monthly testing of the air in the reuse room in the Duluth dialysis unit was instituted in July of 1993.[32] The staff was also instructed to test the air quality whenever they were concerned.[33] OSHA exposure limits for employees for acidic acid is ten parts per million and for hydrogen peroxide is one part per million.[34] The staff was instructed to contact the head nurse immediately if testing showed results in excess of the OSHA thresholds.[35] From 1992 to 1996 staff occasionally made complaints about irritation caused by Renalin fumes in the reuse room.[36] <
><
>20. During November 1992, a certified industrial hygenist, Norbert J. Norman, tested the air in the reuse room in response to staff complaints about odor and irritation.[37] Although he found that exposure levels were below OSHA standards, he noted that the air supply duct was in a faulty location and recommended that it be relocated across from the dilution and Renatron exhaust hoods. He also recommended that the Renatron hood be extended to fully enclose the Renatron machines and the drip pans.[38] A follow-up survey in 1993 by Mr. Norman noted that the improvements had been completed and were helpful.[39] <
><
>21. During 1993 three reuse room tests showed levels of hydrogen peroxide in excess of the OSHA standard and in 1994 two monthly tests showed levels in excess of the standard.[4 Mr. Norman tested the outpatient treatment room for hydrogen peroxide on January 5, 1994 due to concerns about exposure, and concluded that the airborne concentration of hydrogen peroxide and acetic acid were both extemely low.[41]<
><
>22. The recorded test results for 1995 showed two occasions when the hydrogen peroxide exposure was 3.0 parts per million. On each occasion the retest shortly after the first results produced numbers within the OSHA exposure limits. On one occasion in 1996, on May 12, 1996, Ms. Scott recorded a test result of three plus parts per million for hydrogen peroxide.[42] Because Ms. Scott did not report her test results to the head nurse, no retest was done.[43] Ms. Scott conducted the May 12, 1996 test while performing a Saturday ?end to end? disinfect for the dialysis machine. She was having difficulty
eathing and was experiencing severe irritation in her eyes, nose and throat along with nausea and headache.[44] Ms. Scott was a few weeks pregnant at the time of this test.[45]<
><
>23. At a staff meeting on June 17, 1996, staff complained that the reuse room ventilation was inadequate for the Renalin mixing process. As a result of the complaint a special hood was designed and installed in the mixing area in July of 1996.[46]<
><
>24. In early October of 1996 Dan Skorich, a patient care technician, told Scott at work that he had some information that he thought might interest her. Skorich had recently attended an in-service training for the new Superior dialysis unit conducted by a representative from Minntech. Skorich told Scott that the Minntech representative was asked by an employee about exposure to Renalin while pregnant. In response that the Minntech representative took out a letter that stated that because of the absence of studies, Minntech recommended that pregnant women not work with Renalin.[47] At this time Ms. Scott was six months pregnant and was experiencing pre-term labor and nausea.[48] Ms. Scott completed her shift and telephoned Minntech the next day from her home. She asked for a copy of the Minntech letter discussed at the meeting and it was faxed to her on October 14, 1996.[49]<
><
>25. The letter reads as follows:<
><
><
>?April 9, 1993<
><
><
> To Whom It May Concern ?<
><
> Re: Exposure of Pregnant Personnel to Renalin<
><
>Questions are occasionally asked regarding whether pregnant personnel should work with Renalin.? We have in the past, and again recently, referred this question to a medical consultant specializing in occupational medicine. (see attached letter of March 11, 1993). Findings of the resulting independent toxicology review do not show any studies which indicate a human reproductive hazard from hydrogen peroxide, peracetic acid or ascetic acid, which are the active ingredients in Renalin?.<
><
><
>However, the absence of current studies indicating human reproductive hazards from Renalin? is not an absolute assurance of its safety. THEREFORE, Minntech recommends that as a prudent precaution, exposure to Renalin?, and all other such chemicals, should be avoided during pregnancy.<
><
>Yours truly,<
><
>(Signed)<
><
> <
><
>Douglas A. Luehmann<
><
>Vice-President<
><
>Reprocessing Products[5 <
><
>26. Attached to the letter was a copy of a March 11, 1993 letter from Dr. Richard Cohan of the Occupational Medicine Department of Park Nicollet Medical Center to Minntech which concluded that there were no studies which would indicate a human reproductive hazard from hydrogen peroxide, peracetic acid or acetic acid. He noted that hydrogen peroxide had some
mixed results when tested in animals in that it did not cause birth defects in mice or rats but in one study was weakly em
yotoxic and teratogenic to chick em
yos.[51]<
><
>27. Ms. Scott was concerned after reading these letters because she was six months pregnant and had already had exposure to Renalin during her pregnancy. She proceeded to try to obtain additional information about Renalin by researching on the internet and calling organizations but found little information.[52] She then called Pam Elde at Miller-Dwan about her concerns. She also met with Elde and April Johnson during her next shift. During this meeting Ms. Scott requested that she be relieved of the tasks of reprocessing dializers, mixing and dumping Renalin and the Saturday ?end to end? disinfect of the dialysis machines. Elde and Johnson agreed to her request.[53]<
><
>28. Ms. Scott also called Brad Peterson, a chemical engineer with Minntech whose telephone number she had obtained from a friend. Peterson told Scott that there were no studies on the synergistic effects of Renalin?s active ingredients. He also stated that Minntech did not allow its pregnant employees to be exposed to Renalin. According to Peterson, pregnant Minntech employees were not even allowed into the clean room next to the area where Renalin is manufactured. He stated that he would not want his wife to work around Renalin if she were pregnant.[54]<
><
>29. On October 16, 1996 Minntech provided a letter to Miller-Dwan for distribution to its employees concerning Renalin and pregnant personnel. The letter read as follows:<
><
><
>October 16, 1996<
><
>Dear User:<
><
>I recently received a call from your facility director regarding her concerns about the effects of Renalin? exposure on your pregnancy. I would like to take this opportunity to provide you with some background on Renalin? exposure testing and Renal Systems? recommendation that pregnant personnel should avoid exposure to Renalin? cold sterilant.<
><
>Although Renal Systems recommends that exposure to Renalin? and all chemicals be avoided during pregnancy, we do so solely as a precautionary measure. Please be assured that since Renalin? was introduced in 1983, there have been absolutely no reported incidents of human reproductive problems or defects resulting from exposure to Renalin?. I have enclosed a copy of an independent toxicology review that confirms these findings.<
><
>Our past experience has been that pregnant healthcare workers who work with Renalin? will generally inquire about the possible effects of exposure early in their pregnancy. For this reason, our policy has been to issue information regarding exposure of pregnant personnel to Renalin? only in response to a customer inquiry.<
><
>Again, I would like to stress that in the past thirteen years of Renalin? use, there have been absolutely no reported incidents of human reproductive problems or defects as a result of exposure to Renalin? cold sterilant. Because Renal Systems prefers to take a conservative, precautionary approach when it comes to the health and well-being of employees and patients who use our products, we have in the past recommended that healthcare personnel and our own manufacturing employees avoid exposure to Renalin? and all other chemicals during their pregnancy. However, you may want to contact your personal physician to determine what is right for you.<
><
>Please feel free to call me directly at 1-800-328-3345 if you have any further questions or concerns about Renalin?.<
><
>Sincerely,<
><
>(signed)<
><
