Document M4EEr1ydLOyyQXjebw4OOyd1V

STAUFFER CHEMICAL COMPANY Occupational Health Manual: Bulletin Date Issued 10/5/70 Subject Supercedes Bulletin PHYSICIAN1S GUIDELINES FOR AQ-'IINISTRATION AND EVTlLUATION OF PUTMDNAlb.' FUNCTION TESTS OF WORKERS XX lanuing Section . Occupational Medicine No. oi Pages 1 of 9 bulletin No. 100 PHYSICIAN'S GUIDELINES FOR ADMINISTERING AND eyajsuating pulmonary function tests PLAINTIFF'S EXHIBIT SH-2008 Background In chemical manufacturing plants, a number of toxic compounds may be exposed to workers in various jobs. In order to work safely in this environment, the periodic use of respirators may be required. The wearing of any t\pe of respirator, hov.ever, imposes some work stress on the wearer. These additional work demands result from the following factors: A. ) A negative pressure respirator (an air-purifying type) increases the mechanical work associated with breathing by drawing air through a purifying cartridge or filter during inhalation. They also resist exhalation because expired air must force open a valve. The special exhal ation valve on an open circuit pressure-demand self-con tained breathing apparatus (SCEA), designed to ensure positive air pressure inside tlie facepiece, requires the wearer to exhale against considerable resistance. This creates further oxygen demand and results in an additional amount of ventilatory and cardiac work. B. ) All respirators increase the effective anatomical dead ^ space by a variable amount and thus reduce respiratory efficiency. C. ) The weight end size of more complicated respirators (such as a self-contained breathing apparatus weighing up to 35 pounds) end related connections (in the case of air-supplied types having up to 300 feet of air supply hose) place a further physical burden upon the worker which leads to additional work cemends for the pulmonary end cardiovascular systems. ABS-003942 STAUFFER CHEMICAL COMPANY 'Occupational Health Manual: Bulletin Date Issued iO/5/73 Subject Supercedes Bulletin PHYSICIAN'S GUIDELINES FOR AIMTNISTRA.TICN A-'TD EvTTLL'ATICh1 OF PLAGIARY FUNCTION TESTS CF V.'OPLERS XX issuing section Occupational Madicine No. 01 Pages 2 of 9 bulletin No. 100 Any and all of these factors act to increase time work load, If the worker's cardiovascular or pulmonary function is significantly impaired, wearing a respirator may pose an unacceptable risk. As there is limited information available on the physiological effects of certain respirators, it is difficult to' formulate detailed criteria by which a physician ray determine whether a worker can wear a specific respirator and perform useful York safely- Trie most practical approach is to evaluate each subject individually, using reasoned medical judgment based upon history, physical and pulmonary function and other test findings, and v.ith appropriate con sideration to the physical burdens imposed upon an individual by the various types of respirators. MEDICAL HISTORY ALT) CLINICAL EXAM To determine if a respirator may/ be worn safely by an individual, it is necessary' to obtain a medical history/, conduct a physical examine-tion, perform spircore trie studies to evaluate pulmonary' function, chest x-ray and EKG are also usually necessary. Particular attention should be given to cardiorespiratory' conditions. Cardiovascular impairment should be viewed with serious concern because of the potentially ! catastrophic consequences. Workers who have indications of coronary' ! artery disease or angina pectoris probably/ should not wear nen-pewered air-purifying respirators or the heavy/ (30 pound- SCEA) equipment. The same restrictions are reccrmanded for those who have severe hypertension unresponsive to medical therapy or who have had a myocardial infarction. Individuals whose emergency duties absolutely require use of respirators (i.e. "rescue teams") should be completely free of clinical myocardial impairment. In the case of respiratory/ conditions, the subject should be examined for er/idance of respiratory/ impairment resulting from conditions such as emphysema, chronic obstructive lung disease, or bronchial asthma. Historical and radiologic evidence of significant pulmorary disease, if substantiated by reduced ventilatory function, may justify not allowing a parson to wear a respirator that restricts inhalation and exhalation and, instead, limiting him to powered air- purifying or continuous flow airline respirators. If he is reasonably ---C _ rue, mile or moo: rose irater itiens should not iy irchibit a worker from u'earing air-purifying respirators. ;crs in occupations associated with a high incidence of pulmonary' ABS-003943 STAUFFER CHEMICAL COiTPAKY Occupational Health Manual: Bulletin >atc issued 10/5/73 diseases, such as installing asbestos insulation, coal raining, and sand blasting, need particular attention given to nodical evaluation for respirator use. PUi'CciAHi' function To evaluate the pulmonary function characteristics cf a subject, there are a number of studies which rnav be performed, ranging from the basic spircmetric test of forced vital capacity (FVC) and cna second forced expiratory volume' (FEV.) to highly sophisticated investigations of diffusing capacity, airway resistance, and lung compliance. Khan . administered by a trained and kncwledgable .ndivicual and properly performed, tire basic spircmetric studies of FVC and FEV ( are reliable, accurate and, if evaluated in association wr .th nodical history and physical fin-dings, provide sufficient pulmo: sun,-' function data for an informed assessment of any significant respiratory icg-airmant in an individual. There are a number of ccmrrercially available spirometers which may be used to assess pulmonary function. Any spirometer of scientific quality which provides a permanent record (in the form of a tracing as in Figure 1 ) may be utilised. The tracing created by the machine should clearly denote the volume of air expelled (in liters) as well as the testing time involved (in seconds). Both the forced vital capacity (FVC) and the ana second forced expiratory volume (FEY.) may be determined from the same spircmetric study. The FVC is the' mardmal amount of air that can be expelled from the lungs following a maximal inspiration. Cnee a subject is oriented to the operation of a spirometer, this may ba performed as follows: First, remove gum or cough drops prior to tasting. Next, after a period of minimal activity while standing during which cniy quiet, resting breaths are drawn, the subject takes a maximal breath in and then exhales the air in his lungs as quicidy and completely as possible. The tracing which results will be generally similar to Figure 1. Three practical parameters may be obtained from analysis of tills tracing: (1) the FVC v;hich is the total amount of air expelled during a comlete eunalatic.o: (2) the Fie/, which is the volume of air expelled ? r_ 'T T see:id of 100, dav -pieto expiration: nd (3) tine ratio of FEV.,/FVC that can be expelled during the first second. ABS-003944 1 rtlja:K\( CiiLi'iICAL CCriPAiNY :Cccupat ioi.'al Health Maj^al Bulletin Date Issued 10/5/73 Suuject ?; r/sician ' s guidelines FOR ASHE .`I STRATION AIT) F-.T-LUATIOM OF PLTAuTNARS FUN'STION TESTS CF '.'.CRHERS issuing boo cion Occunaticr.al Mad ic ire Supercedes Bull etin XX No. oi iv.gts 4 of 9 Bulletin No. ICO The absolute volume of the FVC is important in that it is an index of tii2 state of the elastic properties cf the raspiratcry system, whereas the rate at which it is expelled iron the lungs is largely a reflection of air flow-resistive prcp*erties. FEV^ is used by most laboratories to analyze flaw resistance. This information will be of limited value unless a cemga Ison of these "actual" results can be made to sere standard. Fortune ely, both nerremravs as well as erections are available to calculate "eic r-v--' 4- parcenary raze Lcn values for an iseu cxn ace. sax, height Thus, the age, sex, height and race should be recorded in order to normal values for each subject. Nomograms and tables of predictive ecu .tiens are often ir.ciud d among the supplies which accompany a spircr. ter. For rererer.ee ana convenience, a preouctuve equation for vital capac Tiiere are two has ,c patterns of pulmonary disease which alter the normal relationship be rc-en expired air volume and time: ebs tracthe and restrictive lung disea: as. The obstructive pattern is caused by resistance to the flew of air ami :g to loss of the leg's normal elasticity or na: r.snng of the umwavs. The result cf obstruction, to the exit of air free the lungs is reflected in the tests cf ventilatory capacity by a decrease in the FEV.,, and FEV/FVOs. The restrictive pattern of disease is caused by processes which scar the lungs and thus prevent them full expansion. This may also result from kyphosis and certain, arthritic diseases. This results in a decrease in the FVC. However, the restriction applies equally to the FEV' , which is reduced to a degree proportional to the FVC reduction. Since 1 there is no obstruction to air flaw, the FEV^/FVCIt is normal. Several practical problems may arise in the performance of spirometry'. The first problem concerns the selection cf equipment to be used. There are a number of carqanies that manufacture spirometers in a variety of sice 3 and shapes. The most importanti characteristics of spirometers to be used in industrial settings are the rGproducibility of accurate res'ults, roil; 'b-ility of perfcrmance, and six.cplicity of use and maintenance. It is also valuable to obtain a permanent tracinr of tie worker's aauual efforts rath- :>r titan just the numerical result s. This can servo as an estimate of the cir.pl; :yee' s effort and cooperaticn cur case questions regarding tl'.e subject' and also as a record in uncticn arise at a later date. ABS-003945 f'-.UrFER CUB-11 CAL COMPLY Occupational Health Manual: Bulletin Date issued 10/5/73 Subject Supercedes Bulletin PHYSICIAN'S GUIDET.INES FOR Aihllh.iSTRATTON - eialuaticn cf pulmttry fit:citon test's of corkers XX Issuing Scccion No. ot Pages Bulletin No. Oocunaticnal Medicine 5 Of 9 100 - Tie second complication to obtaining reliable results is improper instructions or inadequate coaching of the subject by the individuals adiTinistering the tost. The mouthpiece must be placed behind the teeth and the subject should seal his lips around the tube, but not bite it. Interference with air flow by the teeth or tongue may simulate obstructive lung disease in an otherwise healthy parson. Next, the individual should be reminded that the test is not uncccnfcrtable and is easily performed. Finally, when the testing begins, the subject should ba coached vigorously to perform his/her best effore. The last major consideration is that from four to five vital capacity maneuvers are reccrtrended for a thorough evaluation of an individual's pulmonary function. To insure that the subject is giving his/her best effort, the vital capacities of the largest two tracings should be within 10T of each other. Many physicians consider the first two tracings of a series of five to ba "practice runs". Subjects usually need a few trials to become familiar with the equipment and the procedure. In an industrial setring, it is appropriate to simply record the largest FVC and largest FEV^ of the last three trials as the final values for the subject. OT:fER CCIsTSID'F?.ATICbS Several other physical conditions, such as epilepsy or myasthenia gravis, may also limit the v.-earing of respirators. Skin sensitivity or allergy to certain compounds may prevent seme v.orkers from entering certain environments at all, let alone wearing respirators in them. A perforated ear drum which allows air passage through the eustachian tube into the respiratory tract may prohibit a person from working in a toxic environment unless he wears a resoirator with a full head enclosure. Deep facial scars'or'blemished, hollow temples or a markedly receding chin may not alio.-; a good seal cf certain types of respirator facepieces. In addition, full or partial ccr.tures may prohibit the wearing of certain types of mouthpieces and a beard may limit the use of certain facepieces. Psychological factors may also prevent a worker from wearing a respirator. These conditions, however, ere less clearly defined than are physical limitations. Individuals who crmorior.ce claustrophobia or anxiety whan cc-r.fieri in a small space may be distressed by feelings of restriction resulting from the respirator. Others may become unsettled if the respirator has an ill-fitting or irritating facepiece which or:uses continual discomfort. Unless a proper and corniertable fitting is achieved with each individual, the wearing of a respirator is bound to have on adverse psychological effect. ABS-003946 STAUFFER CHEMICAL COMP'NY Occupational Health Manual: Bulletin Date Issued Vvo (M u ZQ 22 2> 15 23 30- 32 .** <- FEMALES M/-Cf '25 13 AGc.fl/e<) -CO- X>|2_S xojlO 15 3C<U 1C- ^c4ix> 7SK25 2Jr to 5.0 A3 i3 U. a a 15 15 2A KT <C.*n) MALES V50 MM? (}!-*<) 1 V2S (lh! 44 xfi X5- ACE oA> Ti2 131 .50. 2J r >.2 v,jL t fll . ncmograms for calculation of standing spirometry in HEALTHY NON-SHOEING ADULTS Fr (0 J For Males: _ Viral capacicy " [27.62 - (0.112 X age)J X (beighc in ca) For Fenales : ' Viral capaciry - [21.7S - <0.101 X aSe)J X (heishr in c=) EQUATIONS FOE CALCULATING VITAL CAPACITY ABS-003947 - CO iAUFFER CHFhICAl COFlPr,J'V Occupational Health manual: Bulletin Dace Issued IO/5/7 n o A twelve-lead electrocardiogram v.dth interpretation should ordinarily be performed as an integral pare of the examination. This test is essential for the assessment of cardiovascular status and for detecting asyngtcmatic, as well as existing, coronary heart disease. A 14" by 17" posterior-anterior chest X-ray with an International Labor Office UICC/Cincinnati (ILO U/C) rating, if available, should also be routinely perferred to aid in the assessment of chest condition. For those cases requiring farcher evaluation, a lateral chest film ray also be obtained. gu: FOR VALUATION After appropriate review has been given to the several historical and clinical factors mentioned previously, working guidelines are necessary as to what constitutes acceptable pulmonary function for wearing a respirator. As .-.cold be expensed, there has been considerable debate about what ray be considered adequate (or, conversely, unacceptable) pulmonary function parar.eters nermittir.g the repaired use of respirators. Generally speaJcing, any worker who has an FS7/1 of 2.5 liters or greater and an 'FZV^ wr h is at least 60% of the FVC should not be expected to have difficult-,' using an industrial re iratcr. On the other hand, workers who have an FETA, of less than 1.7 liters or an FEVh less than 48% of .the FVC are 1. . JL probably unfit to wear an industrial respirator. In any biologic entity, a degree of individual variability must be anticipated and, for that reason, the above absolute and percent FEV^ values should be viewed as helpful but not arbitrary guidelines for evaluation. An FEV^ between 1.7 and 2.5 liters or an FEV^ batv.een 4S% and 60% of the F7C ax5 parameters deserving consideration in conjunction v.dth other data, such as physical findings and work history, about the subject. Information which is helpful in arriving at a decision in all situations involves such factors as the existence of significant cardio respiratory or musculoskeletal conditions, previous or current uncomplicated use of respirators, or difficulties associated v.dth carrying the bulk and weight of the respirator or of a poor fit of the facepiece. In the absence of such conditions, a trial use of the t\ge of respirator to be used should be conducted at the time of the medical examination. The respirator should be worn for a period of 10 minutes at rest. Any significant anxiety or claustro phobic reaction, evidence of significant subjective discomfort, sustained increase in the resting pulse of 25% or more above resting baseline, or sus tained increase in the respiratory rate of 25% or more above baseline, may be viewed as disqualifying the subject for use of that type of respirator. ABS-003948 CO TAUvFER CHEMICAL COMPLY Occupational Health Manual: Bulletin Dal:e issued 10/5/73 In summary, various physiological, psychological as well as historical factors may influence whether an individual should wear a respirator. A number of clinical studies including, but not limited to, a respiratory questionnaire, pulmonary function testing, evaluation of electrocardiogram ABS-003949 SirViJrFER CiiB-ilCAL CGo/AHY Occupational Health Ha. al: Eulletin Date Issued 10/5/73 Sub J ect PHYSICIAN'S GUIDELINES FOR ADMINISTRATION Supercedes Bulletin AND EVALUATION OF PCIIAT-ARY FUNCTION TESTS CF '.-.OldCEPS' XX Icsuir.g Section 4 Occupcticr.al F-adicine Ko. or Pages 9 of 9 bulletin No. 100 I FIGURE 1. FORCED VITAL CAPACITY PIPATIOW THIS PACING 0? VOLUi-fE (Y AXIS) AND TIME (X AXIS) FROM FORCED EXPIRATION HANEUVER ILLUSTRATES THE l AS l RFC TENTS OF FVC AMD FEV I* ABS-003950