Guide to Gas Detection in Healthcare UK

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15. Copyright ChemD AQ Inc. (2014) Page 15 of 16 CM - 118 - A - 0.01 does not fix it. It is far better to get the sterilizer serviced (sometimes small gas/vapor leaks are an indicator that maintenance is required) and if that fails to solve the problem, then adapt work practices as discussed previously to c rack the door open and use the monitor to tell employees when they can safely approach to unload the sterilizer. Another common question is whether a monitor for heavier gases and vapors should be placed low because the gas sinks in air. Those who did Che mistry may remember the experiments with pouring heavy gases and vapors like nitrogen dioxide and bromine that form brown clouds that sink to the floor. In some applications where the air is static (man - holes, grain silos and other confined space entry) st ratification of gases by mass is an important issue. People who go down manholes sometimes put their monitors at ankle height while descending, so that they will hear an alarm before their head reaches that level. For most common applications with high air turnover, the air turbulence is so great that stratification is not significant. The monitors should therefore be placed at breathing height. In conclusion, area gas monitors should be placed near the sources of gas so that they can inform people whether it is safe to be in the area and when it is safe to return to an area after a release of gas or vapor. The monitors should be placed at breathing height, ~ 5 feet (1. 5 m) . Every facility is di fferent and so your ChemDAQ representative will work with you to design a system that meets your needs.

13. Copyright ChemD AQ Inc. (2014) Page 13 of 16 CM - 118 - A - 0.01 Where there are several fr ee standing sterilizers in a row, the best configuration is to have a sensor over every door to provide protection as described above. In some cases, finances demand that a monitor is placed between each pair of ste rilizers. This configuration will detect major leaks of gas or vapor but will not provide warning against small releases of gas or vapor when the sterilizer is opened. If the sub - optimal configuration is used, then work practices should be adopted to ensure that operators are not exposed, for exa mple, at the end of a cycle open the door and wait a short time for any vapors to disperse before emptying the load. Endoscope Reprocessors Many endoscope reprocessors etc. have tops that open and so it is not ea sy to mount a sensor on top of them. In these cases, the sensor should be mounted as close as possible, where it is not in the way. The sensor may be wall mounted or mounted to a post. Typically, the sensor and monitor are mounted on the wall behind the r eprocessor but if space is limited then the sensor should be mounted as a remote sensor with the monitor located at a convenient location further away, but where it can easily be seen by the operator. As with the free standing sterilizer, if the sensor is located further back from the reprocessor it is advisable to step back when opening the lid at the completion of a cycle for a moment to allow any vapors to disperse before removing the endoscope. Placement of Remote Displays The purpose of gas monitoring is to prevent employee exposure and the remote displays play a valuable role. If there is an area monitor in a room, where there is a the potential for a major gas or vapor leak, such that there would be a significant risk to anyone walking into the room, then a remote display on the entrance way makes sense. The remote display is connected to the monitor and mirrors the display on the monitor. Thus a person about to enter the room can see at a glance what the gas/vapor concentration is inside and act accordingly. The remote display is located wherever it will most easily be seen. Typical locations are above the door, or next to the door. If the door has window in it, such that a person outside about to ente r can easily read the monitor display, then the remote display is normally not needed.

16. Copyright ChemD AQ Inc. (2014) Page 16 of 16 CM - 118 - A - 0.01 For additional information, contact ChemDAQ Inc . 300 Business Center Dr, Pittsburgh, PA, 15205 , USA 011 - 412 - 787 - 0202 Fax 011 - 412 - 788 - 2526 info@chemdaq.com www.chemdaq.com Your Local ChemDAQ Representative is:

11. Copyright ChemD AQ Inc. (2014) Page 11 of 16 CM - 118 - A - 0.01 applying for ATEX later this year. The Steri - Trac sensor module is cert ified as intrinsically safe by Intertec (www.intertek.com ) to UL standards 913, 60079 - 0, 60079 - 11 and CSA C22, no. 157; for use in a hazardous atmosphere; Class 1, Div 1, Group s C & D, and T3. In the intrinsic safety configuration the sensor module is placed in the classified area and is isolated from the monitor located in a safe location, by a barrier box. Placement of Monitors An area monitor, as the name suggests, is intended to monitor an area to determine if and when it is safe for people to be there. If the concentration of the target gas is too high, then the area monitor will provide an alert and workers can correct the probl em or leave the area. If an area is evacuated, the monitor serves to both warn others not to enter the affected area and to show when it is safe to return. Area monitors should be placed close to potential sources of the gas or vapor being monitored, so for example if the gas 28 is hydrogen peroxide used for hospital sterilization, then the monitors should be placed close the sterilizer. An area monitor should detect the gas before it reaches the people working in the area. The monitors should be placed at a height similar to breathing zone for most people, typically about five feet (1.5 m) off the floor. The sensor or sampling point should be open to air and not covered or blocked. Range of Monitor A common question is how far can a gas monitor detect gas, and the accurate answer for diffusion type sensors is that the sensors detect only the gas that reaches them. It is possible to model the gas diffusion in static air, but the results are of little use because this mode l does not apply to real life. In a typical hospital sterilization department, with large air turnovers (e.g. > ~10 turnovers/hr) it is difficult to predict how far the gas will travel because of the rapid turbulence of the air. Gas detection instrument ma nufacturers use a rule of thumb that gas monitors have a maximum radius of detection of about 4 feet (1.2 m) and so two gas monitors should be no more than 8 feet apart (~3m). Distance Between Monitors Howeve r, the optimum design of the gas monitoring system must take into account the placement of the gas sources, e.g. (sterilizers), abators and ventilation relative to the operator. If the operator is very close to the gas source, 28 In normal usage, a compound in the air is considered to be a gas if the boiling point of the compound is below ambient temperature, but a vapor if the boiling poi nt is above ambient. In this report the terms gas and vapor are used interchangeably.

10. Copyright ChemD AQ Inc. (2014) Page 10 of 16 CM - 118 - A - 0.01  DAQ ™ Computer : The DAQ is a computer that receives data from the monitors (any combination of gases), calculates the time weighted average (TWA) valu es of the exposure and displays the instantaneous and TWA values and alarms if the TWA’s exceed preset alarm limits. The DAQ also warns if a channel is approaching the TWA limit (impending alarms). The DAQ also has graphing, reports and can export the data as a .csv (text) file for import into Excel or other spreadsheet or to an SQL data for real time interfacing to building systems. The DAQ can operate up to fou r zones, each with up to 8 monitors, thus a single DAQ can be connected to up to 32 different monitors of any gas combination offered by ChemDAQ. Certifications The ChemDAQ Steri - Trac has a CE mark for electrical safety and EMI. The electrical safety and EMI testing was performed and is certified by Met labs ( www.metlabs.com ), to EN standards 61010 - 10 and EN ICES - 003. For ou tside Europe, the Steri - Trac is certified by Metlabs to th e UL & CSA standards for electrical safety 61010 - 10 and FCC EM interference/susceptibility (47 CFR part 15 subpart B). The Steri - Trac system is not currently ATEX certified for use in hazardous/classified areas (where there is a risk of explosion), but we will be

14. Copyright ChemD AQ Inc. (2014) Page 14 of 16 CM - 118 - A - 0.01 Placement of DAQ The placement of the DAQ computer needs to serve several purposes. In normal operation, the DAQ calculates and i f necessary sounds the TWA alarms and so the DAQ must be placed near the work area. In addition, for routine practice of printing reports etc., the DAQ should be in a convenient location. However, in the unlikely event of a major leak where the work area i s evacuated, the DAQ should still be accessible in order to determine when it is safe to return. I f the DAQ is located in the manager’s or supervisor’s office , this location may be a problem in an emergency situation if the office is within the affected area. One solution is to place remote video displays in the work area so that operators can see the TWA values and receive the alarm and the DAQ itself can be placed further away. The remote video display mirrors the DAQ’s display and so shows the current and TWA exposures for all monitors. Some facilities place a remote video display in the security office so that current gas readings and alarm statuses are available to emergency responders. Another solution is to use a second computer in a remote locatio n and connect to it to the DAQ using commercial remote access software such as PC anywhere. The advantage of this second approach is that operators can use the other functions of the DAQ (reports, data export, configuration screens) as if they were in fron t of it. Work Practices As previously discussed, incorporating the gas detection system into work practices is important for improving workplace safety and enabling the safe use of the biocidal chemicals. Some steri lizers may release vapors when they opened at the end of the cycle. For gases such as hydrogen peroxide that have essentially no smell, the monitor provides a reliable way to determine that the concentration is safe. If the remote sensor is placed above t he door, then workers can step away from the sterilizer after opening the door and return once the monitor says it is safe to do so. Even for vapors such as peracetic acid which has a smell, few people’s noses are sufficiently calibrated to be able to dete rmine the concentration from odor and so determine if the level above or below safe levels. It is important that the remote sensor be placed above the door and not be pushed back since the plume of gas coming from the sterilizer is likely to completely pa ss by a sensor that has been pushed away, but the person leaning in to unload the sterilizer may not be so fortunate. Some users have pushed the sensor back because it kept responding whenever they opened the sterilizer door. Moving the sensor only masks the problem, it

9. Copyright ChemD AQ Inc. (2014) Page 9 of 16 CM - 118 - A - 0.01 Monitors are currently available for peracetic acid , hydrogen peroxide, ethylene oxide , ozone, oxygen and combustible (LEL). The latter two are primarily used in commercial applications. Each monitor is configured for a specific gas, but c an be factory reconfigured for a different gas.  Sensor Module : the sensor module contains the gas sensor, circuitry to support it, chemical filters (if applicable) and an i nternal battery to enable fast start - up when the sensor module is initially installed . The sensor module plugs into the monitor and passes the current gas readings to the monitor. The sensor module connect s directly on to the monit or or via a remote sensor mount.  Sensor Calibration (SXP) ™ : The ChemDAQ sensor modules , like all gas sensors , require periodic calibration as a basic function check of operation and to ensure that the output matches the actual gas concentration. Field calibration is often problematic, especially with reactive gases such as peracetic acid and hydrogen peroxide. Instead ChemDAQ provides a calibration service for all users of ChemDAQ equipment . ChemDAQ tracks the date since the last calibration, contacts the customer and sends factory calibrated sensors. The customer swaps the sensors (very simple), and returns the old sensors to ChemDAQ ; where the chemical filters are replaced (peracetic acid and ethylene oxide), the batteries recharged and the sensors recalibrated. All calibrations are performed using the target gas, which for hydrogen peroxide and peracetic acid means generating and analyzing the test gas before the sensor modules can be calibrated.  Remote Displays : The remote displa ys look somewhat like the monitor but without the connector for the sensor mount. The remote display is used to warn approach ing people of a gas or vapor leak before they enter the area. The remote display mirrors the monitor display and horn alarm status. One monitor can be connected to and power up to three remote displays.

12. Copyright ChemD AQ Inc. (2014) Page 12 of 16 CM - 118 - A - 0.01 then the gas monitors should be closer. For example if the gas source is 10 feet away from the operator and the monitor is between the gas source and the operator, that one monitor will suffice since the gas has to pass the monitor to reach the operat or. If however, the gas source is close to the operator, such as a hospital sterilizer immediately in - front of the operator, waiting to be unloaded, then a monitor four feet way would be ineffective. In this last scenario, the monitor should be placed as close as possible to the sterilizer door, and in many cases it is preferably placed directly over the door. Hospital Chemical Sterilizers and Reprocessors Wall M ounted Small Sterilizers We are often asked about the best placement of a monitor on or near a small sterilizer of the type commonly used in hospital s . These sterilizers are about the size of a home dishwasher and may be either free standing or wall mounted. If the sterilizer is wall mounted, then we recommend placing a monitor on the wall close to the front of the sterilizer. Sterilizers can potentially leak from the door when it is opened and so we need a monitor close by to provide suitable warning. This is parti cularly true in situations where users regularly open the sterilizer door and reach in to remove the load. Ideally, the monitor is closer to the gas source than the operator, but for operations such as unloading a sterilizer, the monitor should be placed a s close as possible. If there is a risk of leakage from the back of the sterilizer, then a monitor should be placed there as well. A monitor at the back is especially important where the rear of one or more sterilizers is in a utility space, such that an y leak may build up in there and affect anyone entering the area. Free Standing Small Sterilizers If the sterilizer is a free standing unit, the sensor should be placed above the door ( ChemDAQ’s remote sensor ) and have a monitor on a nearby wall. If above the door is not possible, then as close to the front of the sterilizer as possible. Sterilizers can sometimes emit gas or vapor when the door is first opened after a cycle. We have seen 30 to 40 ppm hyd rogen peroxide be emitted by some sterilizers each time the door was opened, significantly higher than the HSE WEL 29 of 1 ppm (8 hr TWA) and similar magnitude to the NIOSH Immediately Dangerous to Life and Health value (75 ppm). 30 29 EH40/2005, available from http://www.hse.gov.uk/pubns/books/eh40.htm . 30 http://www.cdc.gov/niosh/idlh/int ridl4.html , retrieved 2/12/14

1. Copyright ChemD AQ Inc. (2014) Page 1 of 16 CM - 118 - A - 0.01 G uide to G as Detection in Healthcare in the United Kingdom Table of Contents Introduction ................................ ................................ ................................ .......... 2 Occupational Exposures ................................ ................................ .................. 2 Exposure Limits ................................ ................................ ......................... 2 Applicable Regulations ................................ ................................ ................... 4 COSHH ................................ ................................ ................................ ........... 5 Accreditation Bodies ................................ ................................ ....................... 6 Care Quality Commission ................................ ................................ .......... 6 Joint Advisory Group on GI Endoscopy ................................ .................... 6 Authorising Engineer (Decontamination) ................................ .................. 8 Overview of The ChemDAQ Steri - Trac ™ System ................................ ............. 8 Monitor ................................ ................................ ................................ ........... 8 Sensor Module ................................ ................................ ................................ 9 Sensor Calibration (SXP) ™ ................................ ................................ ............. 9 Remote Displays ................................ ................................ ............................. 9 DAQ ™ Computer ................................ ................................ .......................... 10 Certifications ................................ ................................ ................................ . 10 Placement of Monitors ................................ ................................ ....................... 11 Range of Monitor ................................ ................................ .......................... 11 Distance Between Monitors ................................ ................................ .......... 11 Hospital Chemical Sterilizers and Reprocessors ................................ ........... 12 Wall mounted Small Sterilizers ................................ ................................ 12 Free Standing Small Sterilizers ................................ ................................ 12 Endoscope Reprocessors ................................ ................................ .......... 13 Placement of Remote Displays ................................ ................................ .......... 13 Placement of DAQ ................................ ................................ ........................ 14 Work Practices ................................ ................................ .............................. 14

3. Copyright ChemD AQ Inc. (2014) Page 3 of 16 CM - 118 - A - 0.01 The US has two federal government agencies related to occupational safety. The National Institute of Occupatio nal Safety and Health (NIOSH) and the Occupational Safety Administration (OSHA). The NIOSH performs research and has developed Recommended Exposure Limits (RELs) for many compounds. The current values are available in the NIOSH Pocket Guide to Chemical Haz ards 2 and the RELs are often quoted on safety data sheets etc. NIOSH also produces a list of Immediately Dangerous to Life and Health Limits (IDLHs) for many chemicals. 3 These relate to the exposure that would cause serious injury or serious impairment p reventing escape. For example the IDLH for ethylene oxide is 800ppm, but for the more corrosive hydrogen peroxide it is 75 ppm. OSHA is the US regulatory and enforcement agency. It has promulgated a series of occupational exposure limits called permissib le exposure limits (PELs). The OSHA PELs are the legal exposure limits in the US, analogous to the UK HSE’s WELs. Even though the OSHA PELs and NIOSH RELs do not have t he weight of the law in the UK, they are still widely used as occupational exposure limi ts, especially for gases and vapors for which there is not a HSE WEL. OSHA PEL Values 4 Compound 8 Hr Exposure Limit (ppm) 15 Minutes Exposure Limit (ppm) Ethylene Oxide 1 5 Hydrogen Peroxide 1 n/a Another important occupational safety organization is the American Conference of Government Industrial Hygienists (ACGIH). Each year the ACGIH publishes their list of Threshold Limit Values (TLV s ) for chemical and biological exposures. The ACGIH is highly respected to the point that most of the OSHA PELs wer e taken from the 1968 ACGIH TLVs and several countries including some Canadian provinces directly reference the TLVs in their occupational exposure laws. 5 2 The guide can be search at http://www.cdc.gov/niosh/npg/ 3 A list of NIOSH IDLHs is available at http://www.cdc.gov/nio sh/idlh/intridl4.html 4 29 CFR 1910.1000 Tbl z - 1 and 29 CFR 1910.1047 (EtO) 5 The sources of the occupational exposure limits for the Canadian Provinces have been summarized as of June 2013 in http://blog.che mdaq.com/?p=88

6. Copyright ChemD AQ Inc. (2014) Page 6 of 16 CM - 118 - A - 0.01 Accreditation Bod ies Care Quality Commission All National Health Service (NHS) hospitals and private healthcare providers must register with the Care Quality Commission (CQC) , the body th at is responsible for UK hospital accreditation and standards. 12 The CQC is a non - departmental public body of the UK government established in 2009 to regulate and inspect health and social care services in England. The primary focus of the C QC is patient c are and little mention is made of worker safety in its 24 essential standards. 13 Regardless of accreditation, the NHS states that it emphasizes worker safety by following the Control of Substances Hazardous to Health Regulations 2002. 14 The management of oc cupational health, safety and well - being is now central to the effective running of the NHS. There is strong evidence linking patient safety, patient experiences and the quality of care with the safety, health and well - being of the workforce. 15 In addition to the CQC, many private hospitals also choose to apply for voluntary accreditation by various bodies . The largest accreditation organization is probably the QHS Trent , 16 a private UK based accreditation organization that use s its own standards. 17 Some inter national accreditation organizations such as the Norwegian based DNV accreditation agency 18 are also used. There are a number of other, smaller and more narrowly focused accreditation schemes in operation as well. 19 Joint Advisory Group on GI Endoscopy More specialist organizations such as the Joint Advisory Group on GI Endoscopy (JAG) 20 also offer support, training programs and accreditation. The JAG standards include a requirement to follow COSHH regu lations as may be 12 http://www.uktreatment.com/why - the - uk/hospital - accredi tation/ 13 http://www.cqc.org.uk/sites/default/files/media/documents/gac_ - _dec_2011_update.pdf 14 http://www.hse.gov.uk/pubns/indg136.pdf 15 Occupational health and safety standards, The NHS Staff Council; http://www.nhsemployers.org/Aboutus/Publications/D ocuments/Occupational%20health%20a nd%20safety%20standards.pdf 16 http://www.qha - trent.co.uk/ 17 Standards are listed (titles only) http://www.qha - trent.co.uk/#!qha - trents - standards/ch6q 18 http://www.dnv.com/industry/healthcare/ , http://www.imtj.com/news/?entryid82=379273 19 http://en.wikipedia.org/wiki/United_Kingdom_Accreditation_Forum 20 http://www.thejag.org.uk/

2. Copyright ChemD AQ Inc. (2014) Page 2 of 16 CM - 118 - A - 0.01 Introduction Biocidal c hemicals play a vital role in modern life and their application has allowed significant advances in reducing infection in healthcare. However the use of sterilants and high level disinfections presents a risk to those people performing these essential tasks and gas monit oring is a part of the means to ensure that these chemicals can be used safely. Occupational Exposures Toxic gas or vapour concentrations are typically measured in parts per million (ppm) or in mg/m 3 . A ppm is a fractional concentration, i.e. if the concentration of peracetic acid is 1 ppm, then of every million molecules in the air, one of them is peracetic acid. For most toxic gases, the effect of exposure is cumulative and thus m ost exposures are assessed as t ime weighted averages (TWAs), such that an exposure of 1 ppm for 8 hours is the same exposure as 8 ppm for 1 hour , or 32 ppm for 15 minutes. The 8 hour limit is sometimes called a long term exposure limit (LTEL). For some vapors, such as peracetic acid, a high concentration for a short time is more harmful tha n the equivalent lower concentration for a longer time. For these gases, a shorter ( 15 minute ) TWA is used, often called a short term exposure limit (STEL). Some gas exposures are based on the instan taneous value, for example the US - OSHA has a permissible exposure limit ceiling for chlorine of 1 ppm. The ChemDAQ monitors show the instantaneous or current gas concentration on the display and the DAQ ™ computer provides instantaneous levels, STELs and 8 hour TWAs and associated alarms. Occupational Exposure Limits The UK’s Health and Safety Executive (HSE) has promulgated workplace exposure limits (WELs) for many ch emicals. HSE WEL Values (EH40) 1 Compound 8 Hr Exposure Limit (ppm) 15 Minutes Exposure Limit (ppm) Ethylene Oxide 5 Hydrogen Peroxide 1 2 1 The current version may be downloaded from http://www.hse.gov.uk/pubns/books/eh40.htm.

8. Copyright ChemD AQ Inc. (2014) Page 8 of 16 CM - 118 - A - 0.01 Staff Training  ...  There is evidence of COSHH training [Training records] ... Authorising Engineer (Decontamination) AE(D) AE(D)s provide impartial auditing and advice on all aspects of decontamination, including cleaning, disinfection a nd sterilization, of medical devices in the acute sector of Healthcare; and Audit of decontamination processes, and decontamination equipment validation and testing reports. 22 AE(D)s are accredited by the Institute of Healthcare Engineering and Estate Manag ement (IHEEM) 23 and there are currently only 34 people holding this position in the UK. 24 A list of the AE(D)s and their contact information is available on the IHEEM website. 25 The AE(D)s are very influential. More information about AE(D)s is available in a May 2011 article. 26 Note: AE(D) should not be confused with t he AP(D) Authorised person (decontamination) qualification for managers and engineers of decontamination departments . This is typically a four day course that covers safety, use and repair of dec ontamination equipment 27 and so there are many more people with this qualification than the AE(D). Overview of t he ChemDAQ Steri - Trac™ System The ChemDAQ gas monitoring system is modular so th at it can be tailored to each customer’s needs; and is made up of the following main components.  Monitor : the monitor connects to the sensor module and displays the current gas concentration. It also has two instantaneous alarm s, high and low. Under normal conditions, the display is green, turns yellow for low alarm and red for high alarm. A horn sounds an alert if the low or high alarms are reached. The monitors also contains two relays, each triggered by the alarm level, that can be used to interface with air handlers, strobes etc. The monitor can operate a s a stand - alone instrument or it can be connected to the DAQ computer. 22 http://www.iheem.org.uk/decontamination 23 http://www.iheem.org.uk/ 24 http://www.iheem.org.uk/write/Documents/M ay%202011.pdf 25 https://www.iheem.org.uk/write/Documents/AE(D)s/AE(D)_Register_2014_ - _Feb.pdf 26 https://www.iheem.org.uk/write/Documents/May%202011.pdf 27 http ://www.eastwoodparktraining.co.uk/Courses/Course.aspx?courseID=146809&code = DAPD&k=titleD

4. Copyright ChemD AQ Inc. (2014) Page 4 of 16 CM - 118 - A - 0.01 ACGIH TLVs 6 Compound 8 Hr Exposure Limit (ppm) 15 Minutes Exposure Limit (ppm) Ethylene Oxide 1 5 Hydrogen Peroxide 1 n/a Peracetic Acid n/a 0.4 ppm The ChemDAQ monitor can easily detect peracetic acid as the STEL (range 0 to 6 ppm, mi nimum detection limit 0.04 ppm). Peracetic acid is used as an equilibrium mixture wit h acetic acid and hydrogen peroxide and so there is always some hydrogen peroxide vapor present with peracetic acid which because of their chemical similarity can potentially cause interference on the sensor . The ChemDAQ peracetic acid monitor includes a p roprietary chemical filter that prevents cross sensitivity to hydrogen peroxide. The US Environmental Protection Agency (EPA) has also issued expo sure limits for peracetic acid ( and many other chemicals) known as acute exposure guideline level s (AEGLs). There are three levels of AEGL, roughly translated as irritating (AEGL 1), irreversible harm, and fatal (AEGL 3); 7 and the AEGL 1 for peracetic acid is 0.52 mg/m 3 (0.19 ppm). 8 It should be noted that the AEGLs are intended to give guidance to emergency res ponders and so apply to a single exposure, not repeated exposure as with an occupational exposure limit. Applicable R egulations The healthcare workplace comes under the same occupational safety laws as other em ployers. Below is a very abbreviated overview of the UK workplace legal framework. 9 6 ACGIH 2014 Guide to Occupational Exposure Values 7 http://www.epa.gov/oppt/aegl/pubs/define.htm 8 http://www.epa.gov/oppt/aegl/pubs/results80.htm 9 The scheme below is intended to give a brief overview; it should not be taken as lega l advice. Please consult a UK lawyer if you have any specific questions. The ACGIH recently announced a new TLV fo r peracetic acid. Peracetic acid is widely used as a biocide in healthcare, food and other industries and until this announcement there were no occupational exposure limits for it. ChemDAQ developed the first monitor for peracetic acid vapor .

7. Copyright ChemD AQ Inc. (2014) Page 7 of 16 CM - 118 - A - 0.01 seen in the safety section copied below ; and so presumably will assess hospitals for their safety program s . 21 Safety  Endoscopy decontamination areas should be designed to ensure an effective and efficient service that does not harm staff, patients or the public.  There is evidence of COSHH risk assessments. [Expect to see Risk Assessments]  Units should have evidence of their risk assessment for the use of Personal Protective Equipment  All staff involved in decontamination have access to an d wear appropriate personal protective equipment including full face visors, single - use gloves and aprons. [Staff interviews]  During manual cleaning, forearms should be protected.  Staff must wear protective equipment as instructed by the manufacturers’ whe n mixing and loading chemicals into the AER.  Respiratory protection is employed against chemical and microbial hazards in line with COSHH assessments.  Health surveillance for staff should be considered, in consultation with occupational health departments for exposures to disinfectants that are not aldehydes or chlorine - releasing agents or other strong irritants. If agents similar to glutaraldehyde are used, then health surveillance should be carried out. [OH policy and staff interviews]  There is a policy and equipment available for spillages; chemicals, detergents, body fluids. [Spillage policy, site visit]  In the event of the inability to provide an automated decontamination system, the endoscopy activity must cease until the automated process is regained. Manual disinfection and rinsing are not acceptable. [Evidence of action taken, staff interviews]  A procedure must be in place for the safe and proper disposal of any residual chemicals, either residual container quantities or quantities beyond their expir ation date, used in the endoscopy reprocessing area. The procedure should include disposal guidelines according to the nature of the detergent or disinfectant, and should specify who is responsible for such disposal. 21 National Endoscopy Program, Decontamination Standards for Flexible Endos copes, March 2009; http://www.thejag.org.uk/downloads/Unit%20Resources/Decontamination%20Standards%20f or%20Flexible%20Endoscopy.pdf#search=

5. Copyright ChemD AQ Inc. (2014) Page 5 of 16 CM - 118 - A - 0.01 There are three main levels of safety laws tha t are designed to work together: 1. European Directives e.g. 90/394/EEC (Carcinogens) and 98/24/EC (Chemical Agents) . These dir ectives apply to countries not individuals. 2. National Laws : Health and Safety at Work etc. Act of 1974 3. N ational Regulations : such as COSHH for workplace safety and CHI PS for labeling and information and the Management of Health and Safety at Work Regulation s 1999 The Health and Safety at Work etc. Act (1974) c reated a legal duty for employers to provide a safe work environment , created the HSE and provided the authority to the HSE to d evelop and enforce COSHH, CHIP and other regulations . COSHH Under the COSHH regulations 10 e mployers must:  Assess the health and safety risks of the workplace  Inform workers of the risks, and the preventative and protective measures  Prevent or adequately controls exposure to hazardous chemicals  Provide appropriate health surveillance The purpose of the COSHH Assessment is to assess the safety r isks . Employers must: 11  Review workplace for potential hazards  Look at both chemicals used and products produced  Identify all chemicals uses  Assess who may be exposed and how ( Some people such as pregnant women may more susceptible )  Identify exposure routes : breathing, eyes, ingestion, skin, skin - puncture  Estimate the chance of exposure occurring  Determine the risk of exposure to employee health and take action to mitigate any significant risks. The use of sterilant and other biocidal chemicals is essential to modern healthcare and gas detection provides a means to enable employers to use these chemicals and their associated equipment safely. 10 The Management of Health and Safety at Work Regulations 1999, COSHH 2002 11 HSE – A Step by Step Guide to COSHH Assessment

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