Hydrogen Peroxide Vapor Exposure from Sterilizers

Public Channel / General

0 0
Assessing Hydrogen Vapor Exposure from Hospital Sterilization

Share on Social Networks

Share Link

Use permanent link to share in social media

Share with a friend

Please login to send this document by email!

Embed in your website

Select page to start with

1. Full Terms & Conditions of access and use can be found at http://oeh.tandfonline.com/action/journalInformation?journalCode=uoeh20 Download by: [] Date: 28 August 2017, At: 14:02 Journal of Occupational and Environmental Hygiene ISSN: 1545-9624 (Print) 1545-9632 (Online) Journal homepage: http://oeh.tandfonline.com/loi/uoeh20 Assessing hydrogen peroxide vapor exposure from hospital sterilizers Robert Cornelia & P. Richard Warburton To cite this article: Robert Cornelia & P. Richard Warburton (2017) Assessing hydrogen peroxide vapor exposure from hospital sterilizers, Journal of Occupational and Environmental Hygiene, 14:9, 150-157, DOI: 10.1080/15459624.2017.1335401 To link to this article: http://dx.doi.org/10.1080/15459624.2017.1335401 Accepted author version posted online: 21 Jun 2017. Published online: 21 Jun 2017. Submit your article to this journal Article views: 31 View Crossmark data

5. JOURNAL OF OCCUPATIONAL AND ENVIRONMENTAL HYGIENE D153 Figure . Sterrad S, Hospital E. 8-hr TWA. From a fugitive hydrogen peroxide vapor con- centration perspective, this sterilizer is performing well. The monitor on a Sterrad 100S from Hospital D showed a maximum instantaneous reading of 0.7 ppm, and did not exceed either 3 ppm 15-min TWA nor 1 ppm 8-hr TWA. However, the gas monitor was located at the back of the sterilizer and so would be unable to adequately detect any hydrogen peroxide emissions from the front of the sterilizer that are potentially in the breathing zone of the operators. The maximum readings were lower than the readings from the other 100S sterilizers. Figure 3 shows the hydrogen peroxide concentration data for a Sterrad 100S in Hospital E. The maximum instantaneous reading was over 12 ppm, and the mea- sured hydrogen peroxide concentrations exceeded 3 ppm 15-min TWA 6 times, but did not exceed 1 ppm 8-hr TWA. The hydrogen peroxide concentrations appear to increase over time and then decrease. The cause of the sudden decrease around December 2011 is not known but is suspected to be due to maintenance. Sterrad 200 Figure 4 shows the hydrogen peroxide concentration data from a Sterrad 200, also from Hospital E. The instanta- neous reading did not exceed 1 ppm. From a hydrogen peroxide vapor concentration perspective, this sterilizer is performing well. A second Sterrad 200 at Hospital E behaved similarly. Figure . Sterrad , Hospital E. Figure . Sterrad NX, Hospital B. Sterrad NX Hospital B has two Sterrad NX sterilizers and their hydro- gen peroxide concentrations were small, as shown for one of them in Figure 5 . Both Sterrad NX sterilizers at Hospital B show minimal hydrogen peroxide concentra- tions. The instantaneous concentration values are at or below 0.3 ppm. From a hydrogen peroxide vapor concen- tration perspective, these sterilizers are performing well. The two data sets for Sterrad NX sterilizers from Hospital F are generally similar to each other (one is shown in Figure 6 ), again probably because the two ster- ilizers are adjacent to each other. The hydrogen perox- ide concentration from the NX sterilizer in Areas 2 and 3 did not exceed the 5 ppm instantaneous value, nor did it exceed 3 ppm 15 min. TWA, and it exceeded 1 ppm 8- hr. TWA only one time. The time and duration of this event were similar indicating that both monitors were respondingtothesameevent,mostlikelyfromadjacent the hydrogen peroxide sterilizers as discussed above. All three monitors showed only one time when the 8-hr TWA of 1 ppm was exceeded. Plotting the 8 hr. TWA data for all three areas on reduced time scale shows that all three monitors were responding to the same event. No details of this event are available. Steris V-Pro Significant hydrogen peroxide vapor concentrations were observed by Hospital G, a busy hospital which had four Figure . Sterrad NX, Hospital F. Downloaded by [] at 14:02 28 August 2017

7. JOURNAL OF OCCUPATIONAL AND ENVIRONMENTAL HYGIENE D155 Even if the 3 ppm STEL is not a legal requirement in 48 states, it should serve as a flag for potential exposure risk for two reasons. The first is that Hospital G had four sterilizers in a row and if they were run and unloaded sequentially, then the operator may potentially receive a higher cumulative exposure than the individual moni- tors suggest. The other reason is that hydrogen perox- ide has a National Institute of Occupational Safety and Health (NIOSH) immediately dangerous to life and health (IDLH) value of 75 ppm. [ 24 ] Some of the measured hydro- gen peroxide vapor concentrations are close to half the IDLH and presumably the operators would have been subject to repetitive exposures, had they not been using the hydrogen peroxide monitors as described above to limit their exposure. The ACGIH states the following. Excursions in worker exposure levels may exceed 3 times the TLV-TWA for no more that a total of 30 minutes during a workday, and under no circumstances should they exceed 5 times the TLV-TWA, provided that the TLV-TWA is not exceeded. [ 25 ] The ACGIH TLV for hydrogen peroxide is 1 ppm, 8-hr TWA, and according to these guidelines, the maxi- mumexposuretohydrogenperoxideshouldbenomore than 5 ppm. Clearly, some of the exposures recorded here exceed this value and so even though the TWA expo- sures do not exceed the legal PEL, the exposures should be flagged as potentially harmful to employees. Using the hydrogen peroxide monitors as an indicator of when it was safe to approach the sterilizer was only a short-term fix and in July 2012, the sterilizers were relocatedtoacustom-maderoomwithanexhaustvent located immediately above the sterilizer. It can be seen from the graphs for Hospital G that the hydrogen peroxide readings dropped significantly after the relocation. After the move, with the added exhaust ventilation the hydro- gen peroxide peak concentrations were around 5 ppm. Summary of data The data for the sterilizers is summarized in Table 1 . These data sets are for continuous monitoring and so data are being collected even when the sterilizer is not in use, and so as may be expected the median value for all but one of the sterilizers is zero. The mean values of the hydrogen peroxide vapor concentrations are also well below0.1ppmforthesamereason.Themeanexposure wascalculatedasthesumoftheconcentrationmultiplied by the time interval, divided by the total time the monitor was in service. This method was used because a simple mean of the concentrations would read high because the monitors record data at different rates depending on whether the gas concentration is above or below the alarmlevel,andsowouldskewthedatainfavorofhigher values. The median and the standard deviation were however based on the simple measured concentrations and not adjusted for the different time intervals. Table 1 also shows that the statistical metrics vary by sterilizer type, though the sample sizes are small. The Ster- rad 200 have the lowest average maximum value with 0.5 ppm, followed by the NX (average max = 1.8 ppm), the 100S (average max = 5.4), and the V-Pros have the high- est with 34 ppm. The average mean and standard devia- tion values follow similar patterns. Even though the sam- plesizeissmall,thesevaluesdoappeartobeinsimilar magnitude groups for each sterilizer type. Personal and area monitoring The monitors used in this study are fixed point area mon- itors and so it should be noted that a recorded high hydro- gen peroxide concentration does not mean that employees were exposed over this time, simply that there was hydro- gen peroxide in the air at the concentrations recorded. The purpose of area monitoring is to inform people what is in the air so that they can take appropriate action to pre- vent personal exposure. If, for example, the hydrogen peroxide monitor read- ing increases for a short while when the sterilizer door isopened,manyemployers,suchasHospitalG,develop work practices that require operators to open the door, step away and only unload the sterilizer once the reading has returned to safe levels. Hydrogen peroxide has almost no odor and so absent a continuous monitor for hydrogen peroxide, operators would not be aware of any exposure to hydrogen peroxide from fugitive emissions until they experienced the irritation or other health effects resulting from over exposure. Effect of sensor placement The placement of the sensor is important for getting an accurate reading of the hydrogen peroxide vapor concen- tration. For most hydrogen peroxide sensors, the vapor enters the monitor’s sensor by diffusion. Monitors can only measure the concentration of the hydrogen perox- ide vapor immediately adjacent to the sensor. If there is a vapor leak, then the gas is transported to the sensor by diffusion and air movement. If the vapor has a point source, then the concentration away from the source will decrease greatly with distance (volume of a sphere increases with the cube of the radius). If there are air currents, then the concentration of the vapor may vary depending on the direction of the air cur- rents. Therefore, it is important to place the sensor close Downloaded by [] at 14:02 28 August 2017

6. D154 R. CORNELIA AND P. R. WARBURTON Figure . V-Pro Sterilizer, Hospital G. Figure . -min TWA V-Pro-Sterilizer, Hospital G. V-ProSterilizersinthesameroomnexttoeachother.For about the first year, hydrogen peroxide peak concentra- tions in the range of 20–25 ppm (Area 1), 20–37 ppm (Area 2), 30–42 ppm (Area 3), and 20–32 ppm (Area 4) wereobserved.Oneofthesedatasetsisshownin Figure 7 . For these sterilizers, the hydrogen peroxide was detected at the end of the cycle when the door was opened to remove the load. The 15-min TWA for the same data set is shown in Figure 8 . For all four sterilizers, the hydrogen peroxide concentrations frequently exceeded the 3 ppm 15-min TWA, but did not exceed the 1 ppm 8-hr. TWA. The emissions occurred briefly during the day, as seen in Figure 9 , typically lasting approximately 15–20 min. Discussion Hydrogen peroxide is the most widely used low temper- aturesterilantinuseinU.S.hospitalsandinhospitals Figure . Same data as Figure  , expanded scale to one day. of many other countries as well. In addition to being effective, it is environmentally friendly in that if released into the environment, hydrogen peroxide rapidly breaks down to water and oxygen. This high reactivity that makes it environmentally friendly also makes it an effective sterilant and underlies its occupational hazards. ASP’s Sterrad 100S Thisworkhorseofsterileprocessingwasfirstintroduced in the 1990s and is still widely used today. None of the sterilizers tracked gave concentrations exceeded 1 ppm TWAover8hr,butseveralofthemgaveshort-term concentrations of several ppm. The hydrogen peroxide vapor concentrations appear to vary over time, but the cause was not determined. ASP’s Sterrad NX ASP’s Sterrad NX sterilizers start with 59% hydrogen peroxide and internally concentrate it to over 90% in order to produce a more potent sterilization vapor and thus a shorter cycle time. [ 23 ] Despite the higher inter- nal hydrogen peroxide concentration, the vapor concen- tration measured above the door was, with only a few momentary exceptions, below that of the 100S sterilizer and the instantaneous peaks were typically only fractions ofapartpermillion.Fromahydrogenperoxidevapor concentration perspective, the Sterrad NX sterilizers in this study performed very well. Steris Corporation’s V-Pros The four new Steris V-Pro sterilizers at Hospital G were located next to each other in a small room with a continu- ous monitor for hydrogen peroxide placed on top of each sterilizer (Areas 1–4). All four sterilizers emitted hydro- gen peroxide vapor with a measured concentration in the 25–40 ppm range when the door was opened at the end of the cycle. The hospital was very concerned about the high hydrogen peroxide concentrations, but the manufacturer determined the sterilizers were functioning correctly. In the short term, the hospital resolved the problem by instructing the employees to open the sterilizer at the end of each cycle, and step away until the hydrogen peroxide monitor indicated it was safe to unload the sterilizer. While the TWA exposures frequently exceeded 3 ppm over 15 min, there is no STEL permissible exposure limit (PEL) in the U.S. outside of Hawaii and Washington and there was almost no exposure exceeding the OSHA PEL of 1 ppm TWA over 8 hr. Therefore, these measured concentrations did not exceed the legal occupational exposure limits. Downloaded by [] at 14:02 28 August 2017

4. D152 R. CORNELIA AND P. R. WARBURTON Table . Summary of hydrogen peroxide readings. Sterilizer Model Hospital (area) Time (yrs) Max (ppm) Mean(b) (ppm) Median (ppm) SD (ppm)  E() . . .  .  E() . . .  . Average 0.5 0.001 0 0.010 NX B() . . .  . NX B() . . .  . NX F() . . .  . NX F() . . .  . Average 1.8 0.002 0 0.72 S A() . . .  . S B() . . . . . S B() . . .  . S C() .  .  . S D() . . .  . S E() . . .  . S F() . . .  . Average 5.4 0.033 0.03 0.31 V-Pro G() . . .  . V-Pro G() . . .  . V-Pro G() .  .  . V-Pro G() . . .  . Average 34.0 0.053 0 1.16 this study were Sterrad models 100S, 200, and NX from Advanced Sterilization Products and V-Pro from Steris Corporation. Results Sterrad 100S The data from Hospital A using a Sterrad 100S showed several brief moments when the hydrogen peroxide con- centration exceeded 1 ppm, but the exposure never exceeded the factory default instantaneous low alarm of 5ppm,the15-minTWAof3ppm,northe8-hrTWAof 1ppm.Fromafugitivehydrogenperoxidevaporperspec- tive, this sterilizer is performing well. A summary of the data from all the sterilizers may be found in Table 1 . The second hospital, Hospital B with a Sterrad 100S, had a large number of small hydrogen peroxide concen- tration readings. The 8-hr TWA exceeded 1 ppm once and twice exceeded the 15-min TWA 3 ppm. The mon- itor would have gone into alarm several times, assuming the instantaneous low alarm was still at the factory default value of 5 ppm. It may be seen from Figure 1 that the hydrogen peroxide emission varies over time, suddenly increasing around October 2012. Increasing hydrogen peroxide vapor concentrations may indicate that the sterilizer requires or will soon require preven- tative maintenance. Gas monitoring can often be used to detect certain maintenance issues before they become significant enough to be observed by other means. The second hydrogen peroxide monitor at Hospital B (shown in Figure 2 ) exceeded 3 ppm 15 min. TWA sev- eral times, and exceeded 1 ppm 8 hr. TWA several times. Figure . Sterrad S, Hospital B. It may be seen that the increase in the fugitive hydrogen peroxide concentration increases for Area 3 is similar to that seen for Area 2. This conformity arises because it is common practice in a busy hospital to have more than one sterilizer lined up next to each other. If one sterilizer starts to emit hydrogen peroxide vapor then this vapor is often also detected by the monitor on the adjacent sterilizer. The monitor on a Sterrad 100S from Hospital C showed a maximum instantaneous reading of 1 ppm, and did not exceed either 3 ppm 15-min TWA, nor 1 ppm Figure . Sterrad S, Hospital B. Downloaded by [] at 14:02 28 August 2017

3. JOURNAL OF OCCUPATIONAL AND ENVIRONMENTAL HYGIENE D151 reported cases of minor irritation from vapors, and one due to a mechanical fault. [ 11 ] There was one report from 2014 in which a hydrogen peroxide monitor was placed above a Steris V-Pro steril- izer and the monitor would go into alarm at the end of the cycle (presumably when the door was opened) result- ing in the department being evacuated. This report is troubling because the sterilizer manufacturer’s represen- tative addressed this problem by telling the hospital to move the gas monitor away from the sterilizer, [ 12 ] but it is unlikely that this advice is the corporation’s official policy. Yoshida and Kobayashi [ 13 ] performed an investiga- tion into emissions from hydrogen peroxide sterilizers, responding to user complaints of irritation to eyes and throat in a Japanese hospital and found significant leaks of hydrogen peroxide from the exhaust of one Sterrad 200 sterilizer. Leaks were found to be between 1 and 200 hundred ppm and were later identified as caused by a bro- ken filter near the vacuum pump. Yoshida and Kobayashi also found residual hydrogen peroxide in the sterilizer chamber at the end of the sterilization cycle of about 10 ppm for an Amsco V-Pro sterilizer (manufactured by Steris Corporation) and 34 ppm from a Sterrad 100S. Their study clearly indicates that mechanical issues can occur with hydrogen peroxide sterilizers and that these issues can cause the sterilizer to emit significant amounts of hydrogen peroxide, well above the Occupational Safety and Health Administration (OSHA) Permissible Expo- sureLimit(PEL)of1ppmcalculatedasatimeweighted average over 8 hr. [ 14 ] Theeffectsofhydrogenperoxideexposurein the workplace have been studied for many years and the current OSHA PEL of 1 ppm was derived from the 1968 American Conference of Governmental Industrial Hygienists’ (ACGIH) threshold limit value (TLV) of 1 ppm, also calculated as an 8-hr time-weighted average (TWA). [ 15 ] In addition to being a strong oxidant, the ACGIH classifies hydrogen peroxide as a “known animal carcinogen, with unknown relevance to humans.” [ 16 ] The ACGIH TLV for hydrogen peroxide has not changed since the 1950s, when it was established based on tests with dogs that found that prolonged exposure to only a few ppm hydrogen peroxide vapor could result in irreversible lung damage. [ 17 ] There has been some discussion about the needforashort-termexposurelimit(STEL)forhydro- gen peroxide [ 18 , 19 ] and two states, Washington [ 20 ] and Hawaii [ 21 ] , have established STEL values of 3.0 ppm (15- min TWA). Outside the U.S. several countries have STELs for hydrogen peroxide including the United Kingdom, which has a STEL of 2 ppm. [ 22 ] For assessing the mea- suredconcentrations,1ppmasa8-hrTWA,3.0ppmasa 15-min TWA and 5 ppm instantaneous levels were chosen as the standards for this study. The goal of this article is to report the concentra- tions of hydrogen peroxide vapor found near hydro- gen peroxide sterilizers in hospitals over a period of several years of regular use, to determine what a typicalriskofexposuretohydrogenperoxideisina healthcare environment from use of hydrogen peroxide sterilizers. Methods Hydrogen peroxide concentrations were measured using a ChemDAQ Steri-Trac R  hydrogen peroxide monitor. The ChemDAQ monitor comes in two versions, one with an integral sensor and the other with a remote sen- sor connected back to the wall mounted monitor by a cable. This latter configuration is typically used for hydro- gen peroxide monitoring with the remote sensor being placed on the top of the sterilizer. In most installations, each sterilizer has its own sensor, located above the door or sometimes one monitor will be placed between two closely spaced sterilizers. These monitors can be used as stand-alone devices or they can be interfaced with a ChemDAQ DAQ R  computerfordataacquisition,TWA calculations and alarms, reports, graphs, data export, etc. The data used for this study was collected and pro- vided by seven different hospitals across the U.S. and Canada (labeled A–G) that use the ChemDAQ gas moni- toring system as part of their workplace safety program. The monitors are on 16 hydrogen peroxide sterilizers of various models in regular use. The data collection period ranges from one to four years. The ChemDAQ gas monitoring system stores both the raw data and the TWA values. Even though the ChemDAQ monitors out- putareadingeverysecond,forfilesizemanagementthe automatically stored data are recorded with a resolution of one point every 15 min if the reading is below the loweralarmlevelandonepointevery20seciftheread- ing is above the lower alarm level. The graphs below show the complete data sets of instantaneous readings, except where the graph indicates that the TWA data are plotted. These data are summarized and for some steriliz- ers plotted in the graphs shown below. At each loca- tion, each gas monitor corresponds to an area (Area 1, Area2,etc.,asshownonthegraphs).Ifahospitalhas monitorsformultiplegastypes(e.g.,ethyleneoxideand peracetic acid), only the areas corresponding to hydrogen peroxide are included here. The sterilizers models used in Downloaded by [] at 14:02 28 August 2017

2. JOURNAL OF OCCUPATIONAL AND ENVIRONMENTAL HYGIENE , VOL. , NO. , D–D https://doi.org/./.. CASE STUDY Assessing hydrogen peroxide vapor exposure from hospital sterilizers Reported By Robert Cornelia and P. Richard Warburton ChemDAQ Inc., Pittsburgh, Pennsylvania KEYWORDS Emissions; gas monitor; hydrogen peroxide; leaks; occupational exposure; sterilizer ABSTRACT This study examines the hydrogen peroxide concentrations measured near four models of hydrogen peroxide sterilizers, from two manufacturers, monitored in seven hospitals across the U.S. and Canada over several years. The results showed that the majority of sterilizers do not emit hazardous levels of hydrogen peroxide and none of them exceeded the OSHA PEL of 1 ppm (8-hr time-weighted average (TWA)), however several of the sterilizers exceeded 3 ppm, the short-term exposure limit in two states: Washington and Hawaii. One hospital found brief concentrations of 25–40 ppm hydrogen peroxide from 4 hydrogen peroxide sterilizers each time they opened the sterilizer at the end of its cycle. Although not exceeding the OSHA PEL, these exposures are of concern since this concentration is roughly half the NIOSH IDLH of 75 ppm, and operators in a busy hospital environment may receive these exposures multiple times a day. Introduction The recognition that the underlying cause of pathogenesis is microbial organisms is one of the greatest advances in medicine, but controlling pathogens remains a challenge to this day. The Center for Disease Control and Preven- tion estimated that in 2011 there were almost 722,000 hospital acquired infections in acute care hospitals in the U.S., resulting in approximately 75,000 deaths. [ 1 ] Effec- tive chemical sterilants play a vital role in controlling infection in healthcare. A good sterilant chemical must be a broad-spectrum biocide (able to effectively kill fungi, viruses, bacteria, even in the sporoidal form), have good penetrating power, good chemical compatibility with equipment materials, and be environmentally friendly. Hydrogen peroxide is one of the few chemicals that meets these requirements. It is an efficient biocide and the vapor has good penetrating ability, especially when helped by the lumen cycles in modern sterilizers. Hydrogen peroxide breaks down to oxygen and water that is safe for the environment and leaves no patient-adverse residues on equipment. Most sterilization of reusable medical devices in healthcareisachievedusingsteam,butfortemperature- sensitive devices, chemical methods are used. Ethylene oxide sterilizers were introduced in the 1950s and hydrogen peroxide sterilizers in the 1980s and the latter CONTACT P. Richard Warburton rwarburton@chemdaq.com ChemDAQ Inc,  Business Center Dr., Pittsburgh, PA . ∗ Sterrad R  is a registered trade mark of Advanced Sterilization Products, Irvine, CA. ∗∗ V-Pro TM is a trademark of Steris Corporation,  Heisley Road, Mentor, OH . are the predominant method of chemical sterilization in hospitals today. Modern sterilizers are highly engineered, incorporate manysafetyfeatures,andaremadetoveryhighstan- dards, but normal wear and tear, malfunctions, failure of engineering controls, and user error can sometimes occur. There have been many anecdotal reports about operators being exposed to fugitive hydrogen peroxide vapors from sterilizers, including, for example, in the Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. For Advanced Sterilization Product’s (ASP’s) Sterrad ∗ R  sterilizers, there were ∼ 400 reports of odors from steril- izers in 2014. Reports include a few mild cases of burning eyes and respiratory irritation. [ 2–4 ] In prior years, there have been a number of cases of skin burns from residual liquid hydrogen peroxide, especially where the cycle was aborted. [ 6 ] Therehavealsobeenseveralreportswhere operators complained of respiratory problems around the sterilizer. [ 7–10 ] For the Steris V-Pros ∗∗ , the other and more recently FDA-approved hydrogen peroxide sterilizer in the U.S. market, there were approximately 20 reports in the FDA MAUDE database in 2014. The majority of these reports were from skin burns resulting from contact with resid- ual liquid hydrogen peroxide on the load. There were also ©  JOEH, LLC Downloaded by [] at 14:02 28 August 2017

8. D156 R. CORNELIA AND P. R. WARBURTON tothesourceandinsuchawayastomeasurethevapor concentration in or close to the breathing zone of the ster- ilizer operator. Most of the hydrogen peroxide emissions occur from residual vapor when the door opened and the maximum occupational exposure is likely to occur as the operators reach in to empty the sterilizer load since the open door is close to the operator’s breathing zone. Based on the above considerations, the best place to locateahydrogenperoxidemonitornearasterilizeris directly over the door. Most of the sterilizers are oper- ated at above room temperature ( ∼ 50 ° C is typical) and so warm vapors released on opening the door will rise to the sensor. However, it is likely that the concentra- tion inside or at the entrance to the sterilizer will be higher. Most of the hospitals in this study reported that the sensor was either flush with the front of the sterilizer orsetback,upto6in.TheonlyexceptionwasHospi- tal D which reported its sensor was set at the back of the sterilizer which explains why the recorded exposures are significantly lower than those of hospitals using sim- ilar sterilizers. If the sensor is pushed back to the back of thesterilizer,thentheresponsetoanyhydrogenperoxide in the operator’s breathing zone will be significantly reduced. Just as with the FDA report cited above, some sterilizer service representatives have recommended that the sensor be moved back as a solution to the monitor showing high hydrogen peroxide readings, but obviously, preventing the sensor from detecting the hydrogen per- oxide vapor emissions does not solve the problem and may put workers at further risk. It should also be noted that the concentrations of hydrogen peroxide measured by the sensors are not just a function of the sterilizer, but also the ventilation and air exchange rates, as can be seen when the sterilizers at Hos- pital G were moved to a location with a dedicated exhaust directly above each sterilizer. These sterilizers are typically used in sterile processing/central services where there is a requirement to have at least 10 air exchanges per hour. [ 26 ] Thus, some of the differences from one data set to the next may be a result of differences in ventilation rather than hydrogen peroxide emission rates from the sterilizers. Conclusions This study has demonstrated that hydrogen peroxide sterilizers are generally safe to use and when operating properly do not present a significant hydrogen peroxide vaporhazardtotheoperators.However,sometimesdueto wear and tear, operator error, failed engineering controls, or other factors, the hydrogen peroxide emissions can sometimes reach higher than acceptable concentrations and the tendency to emit hydrogen peroxide varies with the model. Continuously monitoring for the hydrogen peroxide concentration informs operators and the facility ifhazardouslevelsexistsotheycantakeappropriate action to prevent occupational exposure. References [1] CDC : “Healthcare-associated Infections (HAIs).” Avail- able at http://www.cdc.gov/HAI/surveillance/ (accessed February 5, 2015). [2] FDA : “Food and Drug Administration MAUDE Adverse Event Report: Advanced Sterilization Products Sterrad 100s Sterilizer Sterrad Equipment (MLR) “Burning eyes and skin rash.” FDA MAUDE Report Num- ber 2084725-2009-00322, 100S, 5/26/09. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfma ude/Detail.CFM?MDRFOI__ID = 1395919 (accessed March 16, 2015). [3] FDA : “Food and Drug Administration MAUDE Adverse Event Report: Advanced Sterilization Products Ster- rad NX Sterilizer Sterrad Equipment (MLR) “Watery eyes and a bothersome throat.” FDA MAUDE Report Number 2084725-2009-00236, NX, 3/25/09. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfma ude/Detail.CFM?MDRFOI__ID = 1386859 (accessed March 16, 2015). [4] FDA : “Food and Drug Administration MAUDE Adverse Event Report: Advanced Sterilization Prod- ucts Sterrad NX Sterilization System Sterilizer “Difficulty breathing, burning eyes, and a foreign taste in her mouth.” FDA MAUDE Report Num- ber 2084725-2008-00100, 3/4/08. Available from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfma ude/Detail.CFM?MDRFOI__ID = 1025087 (accessed March 16, 2015). [5] FDA : “Food and Drug Administration MAUDE Adverse Event Report: Advanced Sterilization Products Ster- rad 200 Sterilization System Double-Door Unit with Stainless Steel Exterior Sterrad Equipment (MLR) “eye and throat irritations.” FDA MAUDE Report Num- ber 2084725-2009-00081, 200, 2/13/09. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfma ude/Detail.CFM?MDRFOI__ID = 1315493 (accessed March 16, 2015). [6] FDA : “Food and Drug Administration, Medical Device Recalls, Class 2 Recall, STE RRAD NX Sterilizer, Posted February 8, 2008, recall number Z-0848-2008.” Available from http://www.accessdata.fda.gov/scripts/cdrh/cfd ocs/cfRes/resCollection_2.cfm?ID = 66413&CREATE_D T = 2008-02-08 (accessed March 16, 2015). [7] FDA : “Food and Drug Administration MAUDE Adverse Event Reports: Advanced Sterilization Products Ster- rad NX Sterilizer Sterrad Equipment (MLR), Report No. 2084725-2009-00421.” 6/19/09. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfma ude/Detail.CFM?MDRFOI__ID = 1414393 (accessed March 16, 2015). [8] FDA : “Food and Drug Administration MAUDE Adverse Event Report: Advanced Sterilization Products Ster- rad 200 Sterilization System Double-Door Unit with Downloaded by [] at 14:02 28 August 2017

9. JOURNAL OF OCCUPATIONAL AND ENVIRONMENTAL HYGIENE D157 Stainless Steel Exterior Sterrad Equipment (MLR).” Report No. 2084725-2009-00287. 4/16/09. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfma ude/Detail.cfm?MDRFOI__ID = 1386882 (accessed March 16, 2015). [9] FDA : “Food and Drug Administration MAUDE Adverse Event Report: Advanced Sterilization Prod- ucts Sterrad 100s Sterilizer Sterrad Equipment (MLR).” Report No. 2084725-2009-00291, Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfma ude/Detail.CFM?MDRFOI__ID = 1391745 (accessed March 16, 2015). [10] FDA : “Food and Drug Administration MAUDE Adverse Event Report: Advanced Sterilization Prod- ucts Sterrad 100nx Sterilizer Sterrad Equipment (MLR).” Report No. 2084725-2009-00276. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfma ude/Detail.CFM?MDRFOI__ID = 1378493 (accessed March 16, 2015). [11] FDA : “Food and Drug Administration, MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. V- PRO 1 PLUS STERILIZER.” FDA MAUDE Report Num- ber, 3005899764-2014-00071. 8/27/14. Available at http:// www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/ Detail.CFM?MDRFOI__ID = 4042489 and report num- ber 3005899764-2014-00026 (accessed March 16, 2015). [12] FDA : “Food and Drug Administration, MAUDE Adverse Event Report: Steris Mexico, S. DE R.L. DE C.V. V-PRO MAX Sterilizer.” FDA MAUDE 3005899764- 2014-00103, Event date 9/17/2-14. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfma ude/Detail.cfm?MDRFOI__ID = 4174968 (accessed March 16, 2015). [13] Yoshida, R., and H. Kobayashi :“ProblemsonHydrogen Peroxide Sterilisation — New Proposal for Safety and Effective Use.” Presented at the Annual WFHSS and JSMI Conference 2012 13th World Sterilization Congress. November 23, 2012. Available at http://www.wfhss.com/ html/conf/wfhss-conference-2012/lectures/wfhss_conf2 0121121_lecture_sp_s702_en.pdf (accessed February 5, 2015). [14] “Toxic and Hazardous Substances, TABLE Z-1 Limits for Air Contaminants.” Code of Federal Regulations , Title 29, Part 1910, section 1000 TABLE Z-1 2017. [15] OSHA : Permissible Exposure Limits - Annotated Tables, US Occupational Safety & Health Administration.” Available at https://www.osha.gov/dsg/annotated-pels/ (accessed March 18, 2015). [16] ACGIH : 2014 Guide to Occupational Exposure Val- ues, Compiled and published by ACGIH. Available at https://www.acgih.org/forms/store/ProductFormPublic/ 2014-guide-to-occupational-exposure-values . [17] Oberst, F. W., C. C. Comstock, and E. B. Hackley : Inhalation toxicity of ninety per cent hydrogen perox- ide vapor, acute, subacute and chronic exposures of lab- oratory animals. Arch. Indust. Occup. Hyg. 10 :319–327 (1954). [18] Mastrangelo,G.,R.Zanibellato,E.Fadda,J.H. Lange, L. Scoizzato, and R. Rylander : Exposure to hydrogen peroxide and eye and nose symptoms among workers in a beverage processing plant. Ann. Occup. Hyg. 53 (2):161–165 (2009). Available at http://www. rmaoem.org/Pdf%20docs/H2O2%20exp%20in%20bev% 20proc%20wkrs.pdf (accessed March 16, 2015). [19] Gagnaire,F.,B.Marignac,G.Hecht,andM.Héry : Sensory irritation of acetic acid, hydrogen perox- ide, peroxyacetic acid and their mixture in mice. Ann. Occup. Hyg. 46 (1):97–102 (2002). Available at http://annhyg.oxfordjournals.org/content/46/1/97.full (accessed March 16, 2015). [20] Washington State Legislature : “Permissible Expo- sure Limits (PELs).” WAC 296-841-20025. Available at http://apps.leg.wa.gov/wac/default.aspx?cite = 296-841- 20025 (accessed March 16, 2015). [21] HIOSH : “Hawaii Administrative Rules, Title 12, Depart- ment of Labor and Industrial Relations, Subtitle 8, Hawaii Occupational Safety And Health Division, Part 2, General Industry Standards, Chapter 60, General Safety And Health Requirements.” Available at http://labor. hawaii.gov/hiosh/files/2012/12/12-60-General-Safety- Health-Requirements.pdf (accessed March 16, 2015). [22] HSE : “EH40/2005 Workplace Exposure Limits.” Pub- lished 2011. Available from http://www.hse.gov.uk/ pubns/books/eh40.htm (accessed March 12, 2015). [23] Sterrad :“SterradNXInstallationRequirementsand Product Specifications, Advanced Sterilization Products Inc. (2012).” Available at http://www.aspjj.com/us/sites/ www.aspjj.com.us/files/AD-53417-01-US_STERRAD-N X-Install-Specs.pdf (accessed March 18, 2015). [24] The National Institute for Occupational Safety and Health (NIOSH) : “Chemical Listing and Documenta- tion of Revised IDLH Values (as of 3/1/95).” Available at http://www.cdc.gov/niosh/idlh/intridl4.html (accessed March 16, 2015). [25] ACGIH : “2014 TLVs and BEIs Based on the Docu- mentation of the Threshold Limit Values for Chemical Substances and Physical Agents & Biological Exposure Indices.”ACGIH.p.5. [26] Association for Advancement of Medical Instrumen- tation Standard : ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3: 2012 & A4:2014 (Consolidated text) Comprehensive Guide to Steam Sterilization and Steril- ity Assurance in Health Care Facilities, Section Ventilation.” Downloaded by [] at 14:02 28 August 2017


  • 80 Total Views
  • 66 Website Views
  • 14 Embedded Views


  • 0 Social Shares
  • 0 Dislikes

Share count

  • 0 Facebook
  • 0 Twitter
  • 0 LinkedIn
  • 0 Google+