CHAPTER VII
Plasma Equipment and Packaging, and
Transfusion Equipment
Part I. Plasma Equipment and Packaging
Most of the dried plasma used in World War II was put up in astandard packaged devised jointly by representatives of the Army (Capt. DouglasB. Kendrick, MC) and the Navy (Cdr. Lloyd B. Newhouser, MC, USN) and modifiedfrom a package devised by Dr. Max M. Strumia (p. 165). These officers weremembers of a Subcommittee on the Standardization of Dispensing Equipmentappointed at the 19 April 1941 meeting of the Subcommittee on Blood Substitutes (1).At the 8 May meeting of the latter subcommittee (2), they wereappointed a continuing committee to test blood substitutes and to test equipmentfor their administration.
There was considerable experimentation before acceptableequipment and packaging were devised and put into production, and occasionalsuggestions were made for their modification after they had been put intogeneral use.
ORIGINAL PACKAGES
The first 15,000 packages of dried plasma delivered by theplasma program were processed by Sharp & Dohme, a firm which had hadconsiderable experience in this field before the emergency arose. The componentsof the unit, consisting of a flame-sealed glass vial of dried plasma, a glassbottle of distilled water, an intravenous needle, and rubber tubing, were ratherloosely packaged in a cardboard box. The unit, which was accepted as a matter ofexpediency, proved unsatisfactory in several respects. Although the flame-sealedampule (figs. 38A and B) represented the best possible storage technique, it hadcertain disadvantages: Its shape required a package undesirably large for fielduse. The neck of the bottle was very fragile, and breakage frequently occurredat the point at which the stopper was inserted. Also, the rubber stopper couldvery easily be pushed down into the ampule when the dispensing needle wasinserted as well as when water was added to reconstitute the plasma. Since theseaccidents were estimated as likely to occur in about 10 percent of packages ofthis type, consideration was given to other models. A later proposal that thecomponents of the Sharp & Dohme unit be put up in cellophane bags was notconsidered practical and was not explored further.
First consideration was given to the container (Vipule)developed at the Reichel Laboratories (fig. 38C). The components of the set wereput up in tin
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cans, but the packaging was so loose that breakage was considered inevitable,especially with a container of this shape and size. The flame-sealed ampulecontained 110 cc. of normal human plasma, and the amount could be doubled bydouble-processing. If plasma were processed twice, however, it lost some of itsstability and flocculation of globulin and fibrin occurred when it wasredissolved. As a matter of expediency, an order was given for 25,000 units,but, as was expected, the equipment did not hold up under use (3, 4).
At a meeting of the Subcommittee on Blood Substitutes on 19 April 1941 (1),a plasma package devised by Dr. Strumia, and suitable for storage of bothfrozen and dried plasma, was demonstrated and evaluated. This package occupiedslightly less space than the Reichel package. It consisted of:
1. A 400-cc. bottle of distilled water, of hard, noncorrosiveglass, with square shoulders.
2. A similar bottle containing 250 cc. of dried plasma, with residualmoisture of less than 1 percent.
3. A gum-rubber vaccine type of stopper, about three-fourths of an inch indiameter, containing a glass airway. After a vacuum had been drawn on the plasmabottle, the stopper was covered with a heavy gel cap.
4. An intravenous set for administration of the reconstituted plasma.
These items were put up in a tin can filled with nitrogen and sealed undervacuum. It was thought that with certain modifications this unit would proveacceptable for field use.
There were further discussions on equipment at the 23 May meeting of theSubcommittee on Blood Substitutes (5), including a discussion of the gageof the needle to be included in the set. Tests showed that when a 22-gage needlewas used, it took 4 minutes to transfer the distilled water to the bottlecontaining dried plasma, against 30 seconds when a l6-gage needle was used.Another minute was required for complete solution of the plasma. With an18-gage needle, the rate of flow was 10-15 cc. per minute. Under pressureachieved by blowing through the cotton-filtered tubes, the entire amount ofplasma (250 cc.) could be administered in 5 minutes. It was finally decided thatthe rate of flow would not be materially increased if a needle larger than 16gage were used and that it might be difficult to insert a larger needle into thevein.
At this same meeting, it was formally recommended that the recommendations ofthe Subcommittee for the Standardization of Dispensing Equipment be adopted bythe Armed Forces. At the next meeting on 18 July 1941 (6), it was furtherrecommended that deviations from standard equipment be permitted only with theapproval of the Field Director, American Red Cross, if they were minor, and onlywith the approval of the National Institute of Health and the Subcommittee onBlood Substitutes, NRC (National Research Council), if they were major.
DEVELOPMENT OF STANDARD PACKAGE
At the 18 July 1941 meeting of the subcommittee (6), the equipment andpackage (fig. 39) devised by Commander Newhouser and Captain Kendrick,
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which were modified from the Strumia model, were recommendedfor adoption by the Armed Forces, and, with only minor modifications in theoriginal model, were used throughout the war. In the development of thispackage, as in many other efforts, Dr. Strumia, Commander Newhouser, and CaptainKendrick worked very closely together (7).
The completed standard package of dried human plasma (CatalogItem Plasma, Normal, Human, Dried, No. 16088) (8) consisted of:
1. A 400-cc. bottle containing the driedsolids obtained from 300 cc. of citrated plasma, evacuated and sealed under 29inches (73.6 cm.) of vacuum. The solid content contained between 17.5 and 18 gm.of plasma protein. An earlier proposal (1) that the labels on plasmacontainers should specify the amount of the original plasma from which the driedplasma had been prepared would have required individual determinations of totalprotein and was rejected as completely impractical.
The bottle was stoppered with a hood-typerubber stopper (fig. 40) and was equipped with a cloth tape for suspending it inthe inverted position while the plasma was being administered.
2. A 400-cc. bottle, with a similar stopperbut sealed without a vacuum, containing 300 cc. of sterile, pyrogen-freedistilled water.
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3. Equipment for intravenous administration,consisting of:
a. An airway assembly, consisting of 9 inchesof rubber tubing, with a needle on one end for insertion into the stopper and acotton filter on the other end.
b. An intravenous injection set, consisting of48 inches of rubber tubing with a glass cloth filter for use during theadministration of the plasma. At one end of the tubing was a glass adapterfitted to an 18-gage intravenous needle. At the other end was a short 15-gageneedle to be used to connect the intravenous set to the plasma bottle.
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The bottle containing the dried plasma, the double-ended needle for addingdistilled water to the plasma, and a clamp were placed in a tin can which wasevacuated to 25 inches (63.5 cm.) of vacuum and sealed. The bottle containingthe distilled water, the intravenous injection set, and the air filter weresealed in another can filled with dry nitrogen. The cans were opened with keysspotwelded to their bottoms. It was not considered necessary to supply alcoholand cotton for skin preparation, since they were standard items of supply.
Both cans were packaged in a tape-sealed, waterproof fiberboard box. It wasspecified that the tape must be pressure-sensitive; waterproof; 1? inches wide;with no rubber content, either crude or reclaimed; not white, and incapable ofreflecting light; and capable of withstanding severe climatic changes withoutappreciable deterioration. Paper tape was not satisfactory. Since the cansfitted snugly into the box, a string was placed around them to facilitate theirremoval.
Instructions for the reconstitution and use of plasma were lithographed onthe can containing the plasma. A label on one end of the finished packageindicated that the blood from which the contained plasma had been made wasfurnished by volunteer donors through the American Red Cross. A questionnairefor recording data on the use of the plasma was enclosed in each package. Allpackages put up after January 1943 bore the warning that the plasma must be usedwithin 3 hours after it was reconstituted.
The metal can used in the Army-Navy plasma package was a standard Navy item,used for the priming charge of explosives. There was therefore no delay in itsprocurement. Later, in order to conserve tin, the Navy directed the American CanCo. to electroplate the can. The ends were made of bonderized steel.
Testing of Package
The standard plasma package was first used under combat conditions at PearlHarbor. Meantime, it had undergone extensive testing (7, 9):
1. Six packages were placed in a refrigerator variously, rightside up, upside down, and on their sides at -4? F. (-20? C.) for 18 hours.When the packages were removed from the refrigerator, all could be openedeasily. The water was solidly frozen, but thawed satisfactorily at roomtemperature, in hot tap water, and in a water bath at 98.6? F. (37? C.),without breakage.
2. Eight packages were placed in a Dry-Ice refrigerator car at-148? F. (-100? C.) for 18 hours, four on end and four on their sides.When they were removed, the tape bindings were frozen, but the boxes were easilyopened at the end of an hour. Thawing of the distilled water was accomplished bythe methods just described, with equal ease and no breakage.
3. Packages forwarded to the Fleet Surgeon, U.S. PacificFleet, were sent out with landing parties and placed under 5-inch (12.7-cm.) and12-inch (30.5-cm.) guns during firing practice and during dive bombing in themonths of May and August 1941. The cans were somewhat battered, but they hadretained full vacuum and there was no breakage.
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The few complaints received about standard Army-Navy plasma packages wereindividual and concerned single units. Complaints about the plasma itself, whichwere also few, are discussed under separate headings.
COMPONENTS OF THE PLASMA PACKAGE
Certain of the components of the standard plasma package require specialcomment, for one reason or another.
Labels
By the spring of 1944, reports began to be received from the Pacific OceanAreas indicating that the white labels used on the plasma packages and thecontained bottles, as well as the gold-colored cans, were serving as excellenttargets for enemy fire when plasma was used in the field during combat.Visibility was reduced by using an olive-drab box; painting the cans olive-drab;and changing the labels, suspension tape, and string used to withdraw the cansfrom the box from white to olive-drab.
Stoppers
The difficulties that arose with stoppers were due chiefly to the increasinguse of synthetics in their manufacture. Lots from one manufacturer becamevulcanized into certain shapes when they were sterilized and, unless they werereused with bottles of precisely that size, they were too loose and had to bediscarded. In some lots, the needles seemed to act as plugs. These and otherdifficulties were eventually eliminated, and several types of stoppers werefound satisfactory (fig. 40).
Some manufacturers placed transparent gelatin (gel) caps over the rubberstoppers used on the water bottles, to prevent deterioration of the rubber. Therubber stopper used on the plasma bottle did not need such protection as the cancontaining it was filled with nitrogen and then vacuum-sealed.
Filters
Whatever equipment was used in the administration of plasma, the"Minimum Requirements for Filtered Normal Human Plasma or Serum" drawnup by the National Institute of Health on 25 February 1941 (p. 279) requiredthat filtration be an integral part of the process. The specification had beenaccepted by the Subcommittee on Blood Substitutes at an earlier meeting (1). Ittook some time, however, for a satisfactory filter to be devised (fig. 41).
Cloth filters had a number of defects (10). Unless they wereconstructed so that the cloth did not adhere to the sidewalls of the glasshousing, the filtering surface was considerably decreased and the tip of thefilter did not act, as intended, as a flow meter. An entirely efficient clothfilter would have been
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undesirably large and would have required the use of acumbersome and readily breakable glass housing.
Glass cloth filters were also not entirely satisfactory (11),one reason being that in mass production they were sometimes so tightlypacked that they acted as baffles instead of filters. Complaints from Attu (12),on the difficulty of placing dried plasma into solution at the temperaturesencountered in the Aleutian Islands, were attributed to the filters rather thanto the cold; dried plasma could easily be placed in solution at a temperatureof 10? F. (-12? C.).
The question of satisfactory filters was discussed in detailat the Conference on Transfusion Equipment and Procedure on 25 August 1942 (13).Some of those present believed that the same filter could be used for plasmaand preserved blood. Others doubted it, even if the filter had an adequatesurface. The problem was solved when the changeover to the larger plasmapackage was made (p. 172) and the glass cloth filter previously used wasreplaced by a small 200-mesh stainless steel filter. The shortage of stainlesssteel of the desired mesh created some difficulties initially, and until itcould be obtained, 100-mesh stainless steel was used and found so satisfactorythat it continued
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to be employed. With the introduction of this type of filter, most filtrationdifficulties ended, though a few were reported on the Normandy beachhead (p.553) and in the Pacific (p. 598).
Tubing
Probably the most serious material shortages in the plasma program concernedthe tubing used in the recipient sets (14). Part of the same problem wasthe deterioration that occurred in rubber during long periods of storage, whichwas inevitable in the stockpiling of plasma. The matter came to a head at theConference on Transfusion Equipment on 25 August 1942 (13), with theappointment of a Committee on Transfusion Equipment (Dr. Elmer L. DeGowin,Chairman, Dr. Strumia, Commander Newhouser, Colonel Kendrick, and Dr. John B.Alsever, Office of Civilian Defense, ex officio). A member of the War ProductionBoard was also appointed to sit with this committee.
A variety of possible substitutes were considered:
1. The Division of Surgical Physiology, Army Medical School,had begun to experiment with cellophane tubing in 1941 and had found that it hadmany desirable features. When properly prepared, it was nontoxic. It could beused efficiently by experienced technicians. It was useful for the injection ofcrystalloid solutions. On the other hand, it was not suitable for general usethroughout the Army, and since it could be used only once, no saving would beeffected in substituting it for rubber.
2. Expendable cellophane tubing prepared by the BaxterLaboratories had been used by the Blood Research Division, Walter Reed GeneralHospital, Washington, D.C., and it was agreed that it could be utilized ifrubber became unavailable.
3. Commander Newhouser hadinstituted studies with vinyl acetate tubing but had not found it suitable (15).Dr. Strumia and his group, however, believed that this tubing could beutilized if certain precautions were taken.
4. The original work with cellulose tubing was done by Hartman(16), at the Henry Ford Hospital in Detroit in 1940. Tests in thelaboratory of the Army Medical School and by a testing board representing boththe Army and the Navy resulted in the decision that it would not withstand therigors of the tropical and arctic regions in which U.S. troops were thenstationed. Since dried plasma was not used in military hospitals in the UnitedStates, it was not thought practical to substitute cellulose tubing for theequipment then in use.
5. It was generally agreed that latex was the most desirablematerial for tubing. While it was collapsible, its walls did not adhere to eachother, and tubing with a caliber of three-eighths of an inch did not retain airbubbles in the column of blood; the air always rose to the top of the column (1).Latex, however, was a new product, and it was in short supply all through1942, because of the necessity of testing samples before orders could be placedor shipments accepted. Additional delays were caused by failures of processorsto follow the specified routine for securing priorities in equipment andmaterials.
In October 1943, a change in specifications resulted in saving some 50percent of the latex formerly required for tubing: It was found entirelysatisfactory to reduce the inside diameter of the tubing from three-sixteenthsof an inch to one-eighth of an inch and the thickness of the wall fromone-eighth to one thirty-second of an inch.
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Tin Cans
In April 1942, the request of Eli Lilly and Co. for additional tinplate touse in cans for the plasma package was refused. On 4 May, at the request of theArmy-Navy Munitions Board, a meeting was called, attended by representatives ofall processors of dried plasma and presided over by the Navy representative onthe Munitions Board (17). Brig. Gen. Charles C. Hillman made thefollowing points:
1. Packages of plasma were subjected to various climaticconditions, ranging from tropical to arctic.
2. Up to this time, no substitute for tin containers forplasma packages had been found. Neither lacquered steel nor plastic was able toretain the nitrogen used in forming the vacuum, which was essential. The presentpackage represented much experimentation by practical engineers. Until anacceptable substitute was found, the use of tin was essential.
3. Contracts about to be let for dried plasma for fiscal year1943 were for 900,000 units of plasma, which would require 1.8 million tin cans.The tin requirement for the 1943 program would therefore be about 18,000 pounds.These packages contained highly critical material. The dried blood plasma wasprocessed from blood donations given by patriotic American citizens for woundedAmerican soldiers, and the tin requirement was very small indeed compared to thevalue of the contents of the cans.
It was the consensus of the meeting that The Surgeon General should makerepresentations to NRC for further assistance in procuring the tin requested;that an appeal be made through proper channels to the War Production Board forat least a 6-month supply for present requirements; and that the presentpackaging be continued while further research was conducted.
At this same meeting, the question of stainless steel in the recipient needleof the intravenous set was also discussed. Difficulties in procurement hadarisen about it. It was considered essential to use stainless steel becauserubber acted adversely upon steel except in a nitrogen atmosphere. If carbonsteel were substituted, it must be expected that a considerable number of plasmapackages would be rendered useless by rust, since it was practically impossibleto keep moisture entirely out of the cannula of the needle. This would probablymake no difference if the plasma were used within a month. If, however, it werenot used for 3-4 years, it might make a considerable difference: When plasma wasneeded, it should be ready for immediate use.
Eventually the tin, as well as most of the other materials needed in theplasma and whole blood programs, was secured, though it required continuous andextended correspondence about even such apparently minor matters as the supplyof paper cups (p. 295).
THE LARGER PLASMA PACKAGE
As early as May 1941, the desirability of a larger plasma package was alreadybeing considered (2, 5). By this time, it was agreed that if a casualtyneeded plasma, 250 cc. was not a sufficient dose. It was thought, however, thatlarger containers might be difficult to carry forward, and there was no doubt
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that a smaller amount, given early and far forward, might be more beneficialthan a larger amount given later in a clearing station. To avoid procurementdelays, the Subcommittee on Blood Substitutes decided to proceed with theproduction of the smaller package but to make the development of a largerpackage a subcommittee objective, with Colonel Kendrick responsible for itsproduction.
By November 1942, requests for larger quantities of plasma had led tointensive work on the preparation of new containers. The small size of the unitwas almost the only serious criticism of the present plasma package. At the 15December 1942 meeting of the Subcommittee on Blood Substitutes (15), itwas pointed out that the amount of plasma in the present package could beincreased in three ways without altering the volume of the package:
1. After 250 cc. of plasma had been dried in the container,another 250 cc. could be introduced and the whole amount redried. This plan wasnot desirable: The volume of the flask would allow for reconstitution to onlytwice the isotonic concentration, and the subcommittee had already recorded itsopposition to the use of concentrated plasma (p. 275).
2. The 250 cc. of plasma dried separately in two bottles couldbe poured into a single bottle. The National Institute of Health was opposed tothis method because no satisfactory means had yet been devised of making thetransfer under aseptic conditions.
3. The amount of plasma dried in the original container couldbe increased from 250 cc. to 400 cc., which would require lengthening the dryingtime to 48 hours, an increase of about 50 percent. For the present, this seemedthe most practical plan, though it was hoped that in the near future a bottlecould be designed which would contain 500 cc. of plasma but would still fit themetal can in use.
Experimental work had shown that by the use of a 750-cc. bottle, 600 cc. ofplasma could be dried to a residual moisture of less than 1 percent. By the useof a 9?-inch can instead of the 7-inch can presently in use, 500 cc. of plasmacould be packaged in a box only 2 inches longer than the box presently in use.Eighteen large packages would occupy the same space as 24 small packages butwould represent the same quantity of plasma as 36 small packages.
To make the change from the smaller to the larger package introduceddifficulties in the supply of critical materials (18, 19). All but two ofthe firms presently processing plasma required material that was critical.Cutter Laboratories listed 14 essential changes, plus 6 others that would benecessary if the amounts of plasma then being pooled were changed. Parke, Davisand Co., which had just achieved production of the smaller packages in excess of3,000 units per week, was dismayed by the changeover. Its dryers were of themanifold type and it was doubtful that the proposed 600-cc. bottles would fit onthem without changes.
The requirements of a single laboratory, Eli Lilly and Co., indicated howserious it was to change specifications for any product during the war. Thisfirm estimated that it would require approximately 5,420 pounds of copper, forwhich it would ultimately release 3,000 pounds of scrap copper; 50 pounds ofbrass; 2,500 pounds of iron; 375 pounds of stainless steel; new equipment formeasuring temperatures by means of thermocouples; and various accessories, aswell as noncritical materials. The highest priority possible would be re-
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FIGURE 42.-Large plasma package introduced in1943. A. Large and small packages of dried plasma. B. Boxopened to show contents arid questionnaire. C. Contents removed from cans. D.Large and small cans of dried plasma, and can of serum albumin, to showcomparative sizes. E. Large and small bottles of dried plasma and vial of serumalbumin. Note texture of plasma after shell freezing and drying.
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quired, including priority for larger bottles and cans, ifproduction were not to be delayed. As matters worked out, this company was readyto begin production before any of the other laboratories, and it was given acontract for 2,000 large units as a trial run.
When all estimates had been received from the variousprocessing laboratories, Col. Charles F. Shook, MC, made a blanket priorityrequest for the necessary critical materials from the War Production Board,which was granted on 6 March 1943.
Production of the larger package (fig. 42) did not beginuntil 1 July 1943. There were numerous reasons for the delay. The company whichmanufactured the cans had to make a number of changes in its equipment and, fora time, was doubtful that the new can would be as strong as the smaller can.Breakage of the distilled water bottles took time to overcome. Finally, sincethe speed of drying, for physical reasons, was partly a function of the plasmashell, it was found difficult to dry 500 cc. of plasma in a bottle not muchlarger than a bottle designed to contain half that amount. These variousproblems were eventually solved, first in the laboratory and then in commercialproduction. In spite of the preliminary difficulties, the changeover was madewith remarkably little trouble, as Colonel Kendrick and Commander Newhouserfound on trips to various laboratories in July and August. Parke, Davis and Co.and Ben Venue Laboratories continued to make the smaller package until the endof the war.
From the beginning, the emphasis in the plasma program hadbeen on the importance of conserving critical materials necessary forprocessing, particularly rubber and metal. The change to the larger packagesaved about half of the rubber tubing previously used, which amounted to manyhundreds of thousands of feet; stainless steel for needles; and other criticalmaterial. The larger package also provided twice the amount of plasma in about athird of the space previously occupied by the smaller package, another importantconsideration in view of the shortage of shipping space.
By the time the larger packages of plasma went intoproduction, medical officers were fully cognizant of the need for largerquantities of plasma for resuscitation-at least 500 cc. was now regarded asthe minimum-and they were delighted to have it provided so conveniently.
PACKAGING OF DRIED PLASMA FOR ZONE OF INTERIOR USE
While dried plasma was not generally used in Zone of Interiorhospitals, it was occasionally needed in both general and station hospitals whenemergencies
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arose. It was also distributed to installations notordinarily supplied with liquid plasma, such as Air Force bases and a variety ofsmaller installations in which plasma was not used sufficiently often, or inlarge enough quantities, to make a supply of liquid plasma practical. Finally,crash ambulances at emergency landing fields were supplied with dried plasma.
During fiscal year 1944, a package for dried plasma to beused in these installations in the Zone of Interior was developed in theDivision of Surgical Physiology, Army Medical School (fig. 43). About 20,000were produced.
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One of the indirect advantages of this package was that it permitted theinstruction of Medical Department personnel in the use of dried plasma, eventhough the packaging differed from that of the oversea supply.
PROPOSED CHANGES
Until almost the end of the war, numerous proposals were made by medicalofficers and others concerning equipment for plasma and blood, most of thesuggestions probably being inspired by the lack of provision in overseatheaters, until late in the war, of equipment for transfusing whole blood. Someof the suggestions were made by physicians of great competence in their specialfields, but they could not be considered when materials were in critical supplyand procured with difficulty and when machines were tooled for bottles,containers, and other equipment in standard sizes. Letters of explanation andappreciation were written to all who made suggestions.
Part II. Transfusion Equipment for theOversea Program
GENERAL CONSIDERATIONS
U.S. Army medical installations went into North Africa in November 1942 withonly the most elementary equipment for transfusion (p. 432). Similarly, U.S.Army units in the European theater had no standard equipment, and the itemsdeveloped before D-day were chiefly improvised.
The selection and procurement of satisfactory transfusion equipment forhospitals in the Zone of Interior was not a problem. Commercially preparedvacuum-type bleeding bottles and donor and recipient sets, which were reusable,became amply available early in the war. On the other hand, equipment used fortransfusion in civilian hospitals was far too complicated for use in the field (1).
Long before the reports of the British and United States experience in NorthAfrica began to be received in the Office of The Surgeon General, personnel ofthe Division of Surgical Physiology, Army Medical School, had been investigatingthe development of transfusion equipment, including equipment for field use(fig. 44). They based their endeavors upon the following hard facts:
1. Wounded men who had lost large quantities of blood in combat were poorsurgical risks, even after they had received plasma in large quantities. Theymust also receive whole blood in large quantities before they could become saferisks for anesthesia and surgery.
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2. A blood program to supply whole blood in the necessary amounts wouldbecome practical only when an acceptable type of transfusion equipment had beendeveloped, together with satisfactory containers for its transportation. The followingcriteria must be met:
a. A sterile closed system must be utilized for the collection and storage ofblood.
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b. A preservative solution must be devised in which blood could be safelystored for 14 to 21 days.
c. A transfusion set must be devised so inexpensive that it could bediscarded after a single using. In civilian life, the chief cause of transfusionreactions was the presence of pyrogens in the recipient sets, usually as theresult of improper cleansing. Under field conditions, the difficulties ofcleaning and preparing collecting and recipient sets would make the use ofequipment that was not expendable both impractical and unsafe. The transfusionset must also be so simple that it could be used by enlisted men with a minimumof instruction, the sine qua non, of course, being the skill necessary to inserta needle in the recipient's vein. Dr. (later Lt. Col., MC) Robert C. Hardinhad shown that this skill could be readily attained (p. 85).
British Proposal
On 20 January 1941, Col. (later Maj. Gen.) Paul R. Hawley, MC, then in theUnited Kingdom as an observer, sent The Surgeon General, at the request of theDirector General, British Army Medical Services, a model of the apparatus usedfor blood transfusion in the British Army (20). A description of theapparatus, with instructions for its use, was contained in the training pamphleton resuscitation. The Director General requested that some consideration begiven to the advisability of standardizing this equipment in the U.S. Army. Theplan seemed to him to have several advantages:
1. Simplicity and economy of procurement, including the savingof rubber by the use of tubing of a single size.
2. Facility of supply of all troops in the same theaters.
3. Similar training of all Allied medical personnel in the useof the same type of equipment, so that, if necessary, reinforcing technicalpersonnel might be exchanged.
The Director General claimed no superiority for this particular equipmentexcept that all British medical units, including Emergency Medical Servicehospitals, were equipped with it, and all personnel had been trained in its usefor some time. He would, however, be willing to consider standardizing someother type of equipment.
It is not clear why this approach was not followed up by The Surgeon General,U.S. Army, except that by this time the investigations at the Army MedicalSchool had made considerable progress. A vacuum bottle had been developed,holding 700 cc., against 400 cc. for the British bottle, and needles andtransparent latex tubing had also been developed. The British tubing was opaque.More important, the British bleeding set was not completely closed. In spite ofthese differences, however, the British transfusion set would probably have beenaccepted for U.S. use if only it had arrived some months earlier.
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DEVELOPMENT OF EQUIPMENT
Improvised Technique
At the meeting of the Subcommittee on Blood Substitutes on 9 April 1943 (21),Colonel Kendrick pointed out that, at that time, the only equipment withwhich blood for transfusions could be collected in medical installationsoverseas was a beaker. The risk of contamination was present even when the bloodwas transfused immediately, and this method was totally inappropriate for thestorage of blood, though it was quite evident, from the large numbers ofcasualties expected, that stored blood in large quantities would be necessary tocare for them. The present plan was to employ plasma exclusively forward ofevacuation hospitals (when the Mediterranean Blood Bank went into operation 10months later, whole blood was employed in field hospitals), but at that, 50,000transfusions might be necessary for each 100,000 casualties.1 Thebottles necessary for this amount of blood would occupy, it was estimated, 6,100cu. ft. of shipping space.
To make up for the lack of standardized equipment and the shortage ofshipping space, the following proposals were made:
1. In evacuation hospitals, all transfusions should be given with freshblood, one reason being the lack of refrigeration for storage of blood; thesingle refrigerator provided was usually filled with biologicals.
2. At general and station hospitals, at which level donors could be moreeasily procured, blood should be collected and shipped forward as necessary. Itwould be collected in the 1,000-cc. Baxter flasks used for intravenous fluids,in 50 cc. of sodium citrate solution. The flasks would be washed in physiologicsalt solution as soon as they were used and would be autoclaved with the rubbertubing and rubber stopper still in situ. A vacuum would be induced with a pump;three such pumps were available in each general hospital. There would be amplerefrigeration, for tables of equipment allowed for three kerosene-burning 8-cu.ft. refrigerators for each hospital.
These proposals were, in general, incorporated in Circular Letter No. 108,Office of The Surgeon General, U.S. Army, 27 May 1943 (22). Instructionswere given in it for the transfusion of fresh whole blood in general hospitalsin oversea theaters within 4 hours after it had been collected and for thetransfusion of stored blood, to be collected by a closed system and used within7 hours after it had been collected (fig. 45). Colonel Kendrick's concurrencein this circular letter was most reluctant but, under the circumstances, thereseemed to be no other choice.
1This was a remarkably accurate estimate, which still holds (1962); 0.5 pint per casualty is the accepted allowance for whole blood in present planning.
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Recommendations
The ad hoc Committee on Transfusion Equipment appointed at the 9 April 1943meeting of the Subcommittee on Blood Substitutes (21) made the followingrecommendations at the 13 May meeting of the subcommittee (23):
1. That the expendable Army-Navy package for dried plasma (p. 165) be usedfor whole blood transfusions in medical installations in theaters of
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operations. When the dried plasma had been reconstituted, the empty distilledwater bottle would provide a closed receptacle which would be sterile and freefrom foreign material. The intravenous and airway assemblies used for plasmainfusion could be salvaged for the administration of blood by cleaning themimmediately.
2. That the anticoagulant solution with glass beads used for filtration bepackaged in individual vials, ready for immediate use.
3. That facilities for preparing and sterilizing equipment for transfusionand storage of whole blood be made available for general hospitals overseas.
These recommendations, it was emphasized, implied supervision of the entireprocess by personnel experienced in the techniques used in the preservation andtransfusion of whole blood.
This plan was frankly an expedient, and an unnecessary one at that. At thistime (May 1943), vacuum bottles were available, and a completely satisfactoryclosed system could have been used for the collection of blood (fig. 44). Theequipment was just as good as any used later for the oversea airlift. Theshipment of these containers overseas, however, was not permitted, and makeshiftarrangements therefore had to be resorted to.
The ad hoc committee pointed out that the plan proposed, while an expedient,did have a number of advantages:
1. Under the plan in effect for the distribution of plasma, the equipmentnecessary for transfusion would be available in large quantities in all overseamedical installations.
2. This equipment lent itself to either open or closed transfusion.
3. It was interchangeable with the equipment currently employed in theadministration of crystalloid solutions.
4. The cleaning of containers would be reduced to a minimum.
5. Shipping space would be conserved, since the necessary equipment wasalready overseas and considered expendable, its original purpose having beenfulfilled. It could therefore be considered expendable after being used fortransfusion.
DESIGN OF FIELD TRANSFUSION UNIT IN EUROPEAN THEATER
Development of Model
Statement of the problems-Early in 1943, when it became evident thatthere were no official plans and no standardized equipment for the use of wholeblood in the European theater farther forward than the communications zone, Maj.(later Lt. Col.) Charles P. Emerson, MC (fig. 46A), at the 5th General Hospital,and Maj. (later Lt. Col.) Richard V. Ebert, MC (fig. 46B), turned theirattention to a number of problems which obviously
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required solution before the use of whole blood in forwardinstallations would become practical (24):
1. Designing a transfusion set that would besimple, sturdy, and easily operated; that would offer a minimum of technicaldifficulties and complications; and that could be used repeatedly, so that anexcessive number would not be required.
2. Devising a method of cleaning andsterilizing transfusion equipment that would be rapid, efficient, and safe; thatwould require no source of heat; and that would involve the use of only thosematerials provided with the set.
3. Restricting the materials used in theconstruction of sets and assembly of kits exclusively to those available in thetheater of operations.
4. Incorporating the transfusion equipment,with all necessary appurtenances, into compact units or kits that could bepacked readily and transported easily.
5. Providing a method of selecting blooddonors that would reduce to a minimum the risk of transfusion reaction's dueto group incompatibility.
First model.-The basic unit of the setdesigned by Major Ebert and Major Emerson was the Baxter Vacoliter flask (fig.47A). It was available in quantity and was calibrated, and its glass and rubbercomponents were excellent.
This model was constructed with a long glass tube extendingto the bottom of the flask. To this long tube was connected an 18-inch piece ofrubber tubing, fitted with a glass adapter for a Luer needle. The blood wascollected through this tubing. A short piece of glass tubing inserted throughthe stopper of the bottle served as an airway. Suction was applied to the airwayto expedite the collection of the blood. At the end of the donation, sodiumcitrate solution was introduced through the long tubing.
When the blood was used, air was introduced into the airwayby means of a blood pressure bulb, to force the blood out of the flask and intothe recipient's vein.
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FIGURE 47.-Evolution of donor bottle inEbert-Emerson transfusion set. A. First model. B. Second model: Rubber stopperwith two holes (a); medicine dropper, cut to 11/8inches (b); glass tube, 10-mm. diameter, 8? inches long (c); medicine dropper(d); gum rubber tube, 14 inches long (e); adapter for Luer needle (f); gumrubber tube, 3 inches long (g). C. Final model, with long glass tube eliminated.
Second model.-The original model, even when modified,proved somewhat cumbersome to use, and it was soon abandoned for a setconstructed with a larger caliber (10-mm.) glass tube, into which a medicinedropper was inserted (fig. 47B). With this model, which utilized a single tubeconnection for both collection and transfusion, the blood flow during thedonation could be observed.
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Third model-A third model (fig. 47C) was constructedwhen it was found that the long rubber tubing which was issued with each packageof dried plasma, and which incorporated both a filter and an adapter, could beconnected to the short glass tube and replace the airway. When the flask wasinverted and suspended by its bale, blood could be injected by gravity, thevenesection tube serving as an airway (fig. 48). This was a convenientarrangement, since plasma was used in sufficient amounts to supply all the rubbertubing necessary. The tubing required no preparation before use and could bediscarded after the transfusion.
This model proved so satisfactory that the pressuretechnique, which had been devised chiefly to eliminate the cleaning andsterilization of long lengths of rubber tubing, was abandoned. In the finalmodel, the long glass tube, which was fragile and difficult to construct, wasalso abandoned.
Several other changes were also made. The modified bloodpressure bulb originally used to expedite the donation and the introduction ofthe sodium citrate solution had not proved particularly satisfactory; it wasreplaced by a Higginson enema syringe (fig. 49). Glass beads were added to theflask when it was found that small clots were sometimes clogging the needle.When the flask was inverted, clots and fibrin particles were removed as theblood filtered through the beads.
Anticoagulant-When the Ebert-Emerson set was firstworked on, early in 1943, no sterile sodium citrate solution was available inU.S. supply depots, and British sources were used for it. Later, it was foundthat sodium citrate was present in sufficient excess in U.S. dried plasma toprovide the amount of anticoagulant required in the field transfusion set. Afternumerous tests of potency, it was found that one part of reconstituted driedplasma prevented the clotting of two to three parts of blood; if one unit (300cc.) of reconstituted plasma was aspirated into the collecting bottle before 500cc. of blood was collected, the blood would not clot. The anticoagulant problemwas thus
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FIGURE 50.-Technique of cleansingEbert-Emerson transfusion set.
solved provided that (1) only group O donors were used in thefield and (2) the recommendation was followed that plasma be given routinelywith whole blood.
Cleaning and sterilization-Cleaning transfusionequipment in the field presented special difficulties, because running waterwould not be available and water alone was not sufficient for cleaning the set.Experiments showed that the Ebert-Emerson equipment could be cleaned rapidly andthoroughly if some alkaline detergent, such as a compound used for dishwashing,were used in aqueous solution and pumped into the set and through the tubingwith a Higginson enema syringe. The alkaline detergent solution completelydissolved the lipoid and protein components of the blood insoluble in neutralsolutions. Water from any available supply was used for rinsing, followed by afinal rinsing with the sterile, pyrogen-free water provided for reconstitutingplasma; a small amount of it was reserved for this purpose (fig. 50).
Sterilization was originally a major problem. Autoclavingtakes a considerable time, and facilities for it were often lacking in thefield. Sterilization by boiling was unsatisfactory for two reasons, (1) thatsmaller sterilizers could not accommodate the set and larger sterilizers weredifficult to heat from available sources, and (2) that the large amounts oforganic and inorganic matter in the water contaminated the sets.
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The sterilization problem was settled by introducing an ounceof 80-percent alcohol into the set immediately after it was cleaned and leavingit in situ until the set was used again. Insertion of the adapter into theairway created a closed system, and inverting the bottle distributed the alcoholto all parts of the set. There were no reactions when this method was used, andexperimental studies showed that sterilization could be accomplished by it inless than 20 minutes.
Transfusion kit-The field medical chest, whichwas originally used as a container for the field transfusion kit, proved toobulky and heavy to be practical. The small wooden box next constructed for thispurpose introduced problems of manpower and supply and proved not sturdy enoughfor field use. Eventually, the ammunition box used for 265 rounds of .50-calibermachinegun cartridges was adapted for this purpose (fig. 51). It was paintedgreen, with a caduceus on the side, and was transported by the handle on thetop. Each box contained three transfusion bottles, 20 ampules of 2.5 percentsodium citrate solution, needles for collecting and giving blood, Novocain(procaine hydrochloride), typing sera, two Higginson enema syringes, alcohol, acleaning compound, pus basins for washing the sets, and a small Luer syringe.
A hand centrifuge was also provided for field use; this wasan essential item, because the errors known to exist on identification tagsrequired group testing before the blood was used, even though only group O bloodwas employed. Crossmatching was considered unnecessary.
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Controversy Over Acceptance of Field Transfusion Unit
Before commenting on the controversy which arose concerningthe use of the Ebert-Emerson field transfusion units, several points should bemade clear:
1. There had been no previous provision in the Europeantheater for transfusion in Army medical installations. The confusion in thetheater was evidenced in December 1943, when a general hospital was informed, inresponse to its inquiry, that it would have to improvise both giving andreceiving sets. It was also suggested that some of the hospital blood bankpersonnel visit the 5th General Hospital and study the field transfusion unitdevised by Major Ebert and Major Emerson.
2. On 27 March 1943, Col. (later Brig. Gen.) Elliott C.Cutler, MC (25), wrote to General Hawley, theater Chief Surgeon, thatstandardization of a portable transfusion unit for combat areas must beundertaken in view of the reports from North Africa and Italy of the largeamounts of whole blood being used in the routine of resuscitation. He had beeninformed by Brigadier Lionel E. H. Whitby, RAMC, in charge of the British Armyblood program, that in British medical installations, the use of wet plasma hadbeen practically abandoned in favor of whole blood.
On 22 September 1943, Colonel Cutler (25) again wroteGeneral Hawley of the urgent need for field transfusion sets. He described theEbert-Emerson set, listing its advantages and pointing out that it had beenapproved by Brigadier Whitby; by Captain Hardin, who had been working with theBritish Central Blood Bank at Bristol for the past 9 months (p. 470); and bymembers of the Professional Services Division, Office of the Theater ChiefSurgeon. He recommended that this set be put in production at once fortransfusion teams to use for the transfusion of severely wounded casualties withblood secured from lightly wounded casualties. He also recommended that thedescription of the set be sent to the Office of The Surgeon General.
3. Communications between the Office of The Surgeon Generaland the European theater were not always rapid, and the circular letter (No.108, 27 May 1943, (22)) in which instructions were given for improvisedequipment for blood transfusion did not reach the United Kingdom until theEbert-Emerson set had been devised, modified, and put into its final form. On26 August 1943, General Hawley pointed this out to The Surgeon General (26),also making it clear that local theater action had been necessary in viewof the lack of any formal plan or standardized equipment for transfusions ofwhole blood.
4. The safety of the equipment devised had been tested bynumerous transfusions on volunteers, the first transfusion with eachmodification of the model being given to Major Ebert and Major Emerson.
Criticism and Countercriticism
On 15 September 1943 (27), and again on 17 September (28),the Transfusion Branch, Office of The Surgeon General, declined toaccept the Ebert-
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Emerson field transfusion unit on the ground that it was inconflict with policies of the Office as set forth in Circular Letter No. 108.The technique described in this letter had been developed with the idea ofutilizing equipment already on hand, which would require only minimumsterilization (intravenous tubing, needles, and filter). Moreover, the plansat this time did not envisage the use of whole blood forward of hospitals inwhich adequate autoclaving facilities would be available for sterilization ofthe sets.
Two specific criticisms of the Ebert-Emerson technique weremade:
1. The method of sterilization was open to question. It wasdoubtful that rinsing with 80-percent alcohol would insure a sterile, pyrogen-freecontainer.
2. Experience had shown that it was much safer to have afilter in the intravenous line during transfusion, to prevent the introductionof small blood clots into the recipient's bloodstream, with the risk ofembolism. When blood was collected or administered by pressure bulb, it was alsodesirable to have an air filter in the line, to reduce the possibility ofairborne contamination.
On 23 September 1943, Major Ebert and Major Emerson sent Lt.Col. Robert M. Zollinger, MC, Senior Consultant in General Surgery, EuropeanTheater of Operations, U.S. Army (29), a memorandum in which theyreiterated that with the techniques which they had employed, they had neverhad a pyrogenic reaction. They had also had no difficulty with clots when theydid not use filters, and they doubted that a clot which could pass throughan 18-gage needle could produce any detectable embolic phenomena.
The following points were also stated in their memorandum:
1. It had been decided that it might be desirable to use theBritish Army transfusion bottle instead of the Baxter bottle in the fieldtransfusion unit. The British bottle was already in use in the theater forstored whole blood, and it might be desirable to standardize all theatertransfusion methods. More important, Baxter bottles were in increasingly shortsupply, and their total unavailability later might constitute an insolubleproblem.
2. The transfusion techniques outlined in Circular Letter No.108 provided for transfusions only in fixed hospitals. The Ebert-Emerson unithad been designed, at the expense it was granted, of certain traditionalrefinements, to meet the need for blood in more forward installations, a needrepeatedly stressed in information from the Mediterranean theater.
Major Ebert and Major Emerson objected to the policies andprocedures set forth in Circular Letter No. 108 for the following reasons:
1. Many of the materials specified for use were not alwaysavailable, especially in forward installations. The 500-cc. plasma unit was notavailable in the European theater. Collection of blood in the 300-cc. distilledwater flask was not practical. After 50 cc. of sodium citrate solution hadbeen introduced into it, the amount of blood that could be collected wouldscarcely be worth the effort. The intravenous fluid flask used in theEbert-Emerson set had a capacity of over a liter. Other items lacking included50-cc. vials of sodium citrate solution with glass beads (Item No. 14306);stainless steel mesh filters in glass housings (Item No. 36099); and 15-gageneedles of the 2-inch hose connector type (Item No. 33578) (fig. 52). Neitherglass beads nor mesh filters (considered unnecessary refinements) were requiredwith the proposed field unit.
2. The open technique recommended in the circular letter waslikely to introduce appreciable amounts of foreign matter into the blood,especially when transfusion was necessary in dusty or sandy atmospheres. TheEbert-Emerson technique was a closed system, in which there was no risk ofcontamination in the receiving flask.
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3. The crossmatching recommended in the circular letter wasnot feasible with the equipment provided for the field. The safest plan was touse O donors exclusively, rechecking their blood group by the high-titer, driedrabbit sera provided by the Army. Donors with weak A2-agglutinogenswere more likely to be identified by this technique than by crossmatching withthe blood of recipients with anti-A agglutinins in low titer.
4. The airway recommended in the circular letter would causethe air pressure in the bottle to be below atmospheric pressure. This situation,plus the fact that the blood must pass through a layer of glass beads, a filter,and two needles, would materially limit the rate of administration. The flowwould be further impeded by the venous constriction often present in casualtiesin shock, whose response to transfusion often depended upon the volume and speedof transfusion. The proposed field unit had been designed for the administrationof blood under pressure, and the model finally evolved did not requiresuspension of the bottle.
FIGURE 52.-Hose hub type of needle designed to connectwith rubber tubing.
On 27 September 1943, Colonel Cutler (30) transmittedthis information through channels to the Office of The Surgeon General,expressing himself as in complete sympathy with it. He also emphasized theimportance of using whole blood in forward installations, as shown by the databeing received from the North African theater, and the urgency of constructingsome sort of transfusion apparatus in the European theater with the materialsavailable there.
Conference of 6 December 1943
Major Ebert was sent to the Zone of Interior on temporaryduty in the late fall of 1943 (31) and attended the conference on bloodtransfusion equipment held on 6 December 1943 (32), in the Office of TheSurgeon General. The frank discussion possible clarified many of the issueswhich had arisen in connection with the proposed field transfusion unit.
Major Ebert emphasized and clarified the following points:
1. The use of only proved O blood.
2. The use of the British transfusion bottle and recipientset.
3. The packing of all the components of the transfusionunit in a single unit in a single compact package, for their efficient use. Sixunits were packaged in each ammunition box used for this purpose.
Major Ebert pointed out that until 500-cc. plasma units weresupplied to the theater, it was impossible to carry out the recommendations inthe 27 May 1943 circular letter. He was told to request the theater medicalsupply officer to requisition a sufficient number of the larger plasma packagesfor all units, so that the distilled water bottle could be used for transfusion.
Since the transfusion equipment then in development in theZone of Interior would probably not be ready for shipment until about 1 February
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1944 (it was not received in the European theater until April1944), it was agreed that the field transfusion unit devised by Major Ebert andMajor Emerson should be put into production and used until expendable bottlesand recipient sets could be supplied. It was suggested that he ask the theatersupply officer to requisition the new equipment promptly, so that it could beshipped as soon as it became available. Major Ebert requested, and was given,samples to take back with him, so that preliminary training with the newequipment could be begun.
EXPENDABLE TRANSFUSION EQUIPMENT
The expendable equipment eventually provided for overseatheaters consisted of a donor set and a giving set, each put up in sealedaluminum foil containers (33).
Bleeding Bottles
Up to late 1944, the blood bank at the 152d Station Hospitalin the United Kingdom used the dumbbell-shaped British bleeding bottles (p.193), into which blood was drawn by gravity or with the aid of mild suctionapplied to the airway by a hand pump. When bottles were finally sent to theEuropean theater from the Zone of Interior, the commercially available vacuumbleeding bottles (fig. 44, p. 178) were selected for several reasons:
1. They had been found extremely satisfactory over theprevious 4 years at the Army Medical School, in the processing of liquid plasmafor Zone of Interior hospitals. Blood banks in general hospitals had also usedthem with equal satisfaction.
2. Their use provided assurance of sterile, pyrogen-freeblood and other solutions.
3. They were economical as well as safe. They were soinexpensive, in fact, that it would not be economical to return them by cargoship or plane to the Zone of Interior for reuse. This was an importantconsideration. The return of needles, tubing and filters from the Continentafter D-day was so slow and incomplete that it was the chief limiting factor insending whole blood to the Continent (p. 551). By the end of June, 7,000 setswere still missing in First U.S. Army scheduled returns. These difficultiescontinued until blood began to be received from the Zone of Interior the lastweek in August.
4. Since the bleeding bottles would be used only once andwould replace locally prepared equipment, they would conserve the personnel usedin each installation to clean bottles and prepare solutions. When Capt. JohnElliott, SnC, reported on his visit to the blood bank at Salisbury in January1945, one of his comments was that 25 to 35 percent of bank personnel wereengaged in the preparation of nonexpendable equipment (34). The change tothe vacuum type of disposable bottles was therefore even more important than itmight seem superficially.
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Donor Set
The disposable donor set consisted of:
One needle, 16-gage.
One needle, 17-gage.
One clamp, Hoffman type.
18 inches of rubber tubing, three-sixteenths by three thirty-seconds inch.
When the set was used, the clamp was placed on the rubbertubing near the 16-gage needle and tightened sufficiently to close the lumen.The needle was inserted through the thickest portion of the rubber stopper ofthe vacuum bottle. The 17-gage needle was inserted into the donor vein. Theclamp was then loosened and was adjusted as necessary to control the rate offlow.
Although the donor set was considered expendable, it could beused five or six times if facilities and personnel permitted proper cleansingand sterilization.
Recipient (Giving) Set
The giving set consisted of (fig. 53):
A filter housing and connector, glass.
A filter, Monel metal, 100-mesh, single-layer.
A perforated rubber stopper.
A glass connecting tube.
An intravenous needle, hose rubber, 18-gage.
An airway tube, metal, 18-gage.
36 inches of rubber tubing, one-eighth by one thirty-secondinch.
The connector at one end of the glass filter housing was usedto engage the bleeding bottle at the free hole. The other end was closed by theperforated rubber stopper.
The glass connecting tube was passed through the hole of thestopper and attached to the rubber hose. The 18-gage intravenous needle wasattached to the other end of the hose. The Monel metal filter in the glasshousing was inserted and held in place by the rubber stopper at the lower end ofthe housing. The filter was inverted, so that blood ran into it, thus increasingits filtration surface by about a third. The metal airway tube, afterinsertion, provided an outlet for the glass airway tube.
When this set was used, the glass housing was completelyfilled, so that there was no break in continuity of the bloodstream between thehousing and the bottle. An adequate head of pressure, extending from the toplevel of the blood in the bottle to the lowest level of the tubing, was thusassured. Thus precaution was essential to provide a steady flow of blood intothe vein.
Critique
It was obviously impossible to supply equipment for theEuropean theater that would be at the same time inexpensive, complete with allrefinements, and acceptable to everyone. The expendable set finally selected hadan adequate
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FIGURE 53.-Disposable blood transfusion (giving) set standardized for Army-Navy use, contained in aluminum tube, and complete with stainless steel filter and 17-gage intravenous needle. A. Components of set. B. Set in use in shock ward in European theater. The blood being used has been preserved in Alsever's solution.
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filtering mechanism and was so constructed that it wascapable of use without difficulty not only by medical officers, many of themwithout special experience in this field, but also by the nurses and enlistedmen who would have to administer most of the blood. It did not provide either adrip indicator or a Luer-tip glass connector for the needles. Both were regardedas unnecessary refinements. The lack of the indicator was compensated for bymaintenance of a steady head of pressure. The rate of flow was automaticallycontrolled by the gage of the needles used, which did not permit blood to beintroduced into the vein rapidly enough to overload the circulation. A simplemeans of determining that blood was running into the vein was to place a drop ofwater or alcohol on the airway outlet. If it was sucked up into the glass airwaytube, it was evident that suction existed and that blood was flowing out of thebottle.
Part III. Albumin Packaging
The package devised by Commander Newhouser and ColonelKendrick was demonstrated at the Conference on the Preparation of Normal HumanSerum Albumin on 5-6 June 1942 (35), and again at the Conference onAlbumin Testing on 19 October 1942 (36). The corrugated fiberboardpackage (37) was small and compact, and had the added advantage, for Navyuse, that it floated (fig. 54). Each package contained the material andequipment for three injections. Instructions for use of the albumin werelithographed on the cans.
The components of the package were:
100 cc. of 25-percent normal human serum albumin preparedfrom human plasma.
One double-ended glass vial, with a rubber stopper at eachend.
One bale (suspension tape) for use with the ampule.
One air filter assembly consisting of a three-fourths inch,16-gage hose hub needle; 1 inch of rubber tubing to fit the hose hub needle; andcotton to be placed in the rubber tubing to serve as an air filter.
One injection assembly, consisting of 40 inches of rubbertubing; one three-fourths inch, 16-gage hose hub needle; one plastic test tubeand stopper to protect the needle; one glass observation tube with ground glassLuer-type tip, 2.5 cm. in length and 2-3 mm. in diameter; one three-fourthsinch, 20-gage intravenous needle, with plastic test tube for its protection.
One metal can (three to package) for each unit of albumin.The key to open the can was spotwelded to the bottom of the can, as in theplasma package.
The metal can used in the Army-Navy serum albumin package wasa standard Navy item, used for the priming charge of explosives. There wastherefore no delay in its procurement. Later, in order to conserve tin, the canwas electroplated. The ends were made of bonderized steel.
Note.-As a matter of convenience, special aspects ofequipment are further discussed under theaters of operations and elsewhere.
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References
1. Minutes, meeting of the Subcommittee on Blood Substitutes, Divisionof Medical Sciences, NRC, 19 Apr. 1941.
2. Report, Subcommittee for the Standardization of Dispensing Equipment,Committee (sic) on Blood Substitutes, Division of Medical Sciences, NRC, 8 May1941.
3. Memorandum, Col. J. H. McNinch, MC, for The Surgeon General,U.S. Army, 2 Feb. 1944, subject: Report of Deficiencies in Packaging of Human Plasma.
4. Memorandum, Lt. Col. Douglas B. Kendrick, MC, to the Chief Surgeon,European Theater of Operations, U.S. Army, 10 Mar. 1944, subject: Report ofDeficiencies in Packaging of Human Plasma.
5. Minutes, meeting of Subcommittee on Blood Substitutes, Division of MedicalSciences, NRC, 23 May 1941.
6. Minutes, meeting of Subcommittee on Blood Substitutes, Division of MedicalSciences, NRC, 18 July 1941.
7. Strumia, M., Newhouser, L. R., Kendrick, D. B., and McGraw,J. J.: Developmentof Equipment for Administration of Dried Plasma in the Armed Forces. War Med. 2:102-113, January 1942.
8. Specifications for Normal Human Plasma, Dried, No. 1546 D, 15 Apr. 1942.
9. Memorandum Report, Lt. Col. Douglas B. Kendrick, MC, to Lt. Col. Burr N.Carter [sic], 14 Dec. 1942, subject: Effect of Low Temperatures on StandardArmy-Navy Dried Plasma Package.
10. Memorandum, Lt. Col. Douglas B. Kendrick, MC, for Maj. Michael E. DeBakey,MC, 1 Oct. 1943, subject: Filters.
11. Minutes, meeting of Subcommittee on Blood Substitutes, Division ofMedical Sciences, NRC, 21 Apr. 1944.
12. Memorandum, Lt. Col. B. N. Carter, MC, for Chief of Inspection Branch,Plans Division, Office of The Surgeon General, 15 Oct. 1943, subject: Report ofOperations on Attu.
13. Minutes, Conference on Transfusion Equipment and Procedure, Division ofMedical Sciences, NRC, 25 Aug. 1942.
14. Memorandums and correspondence concerning tubing for plasma sets, 11Sept. 1942-6 Apr. 1944. [On file, Historical Unit, U.S. Army Medical Service,Walter Reed Army Medical Center, Washington, D.C.]
15. Minutes, meeting of Subcommittee on Blood Substitutes, Division ofMedical Sciences, NRC, 15 Dec. 1942.
16. Hartman, F. W.: Use of Cellophane Cylinders for Desiccating Blood Plasma.J.A.M.A. 115: 1989-1990, 7 Dec. 1940.
17. Minutes, meeting of Manufacturers of Dried Blood Plasma, 4 May 1942.
18. Memorandum, Col. C. F. Shook, MC, for Maj. Gen. James C. Magee, 2 Mar.1943, subject: Specification Meeting.
19. Minutes, Blood Plasma Conference, Division of Medical Sciences, NRC, 24Mar. 1943.
20. Letter, Col. Paul R. Hawley, MC, to The Surgeon General, 20 Jan. 1941,subject: British Apparatus for Blood Transfusion.
21. Minutes, meeting of Subcommittee on Blood Substitutes, Division ofMedical Sciences, NRC, 9 Apr. 1943.
22. Circular Letter No. 108, Office of The Surgeon General, U.S. Army, 27 May1943, subject: Transfusion of Whole Blood in the Theaters of Operations.
23. Minutes, meeting of Subcommittee on Blood Substitutes, Division ofMedical Sciences, NRC, 13 May 1943.
24. The Development of a Field Transfusion Unit, Maj. Richard V. Ebert, MC,and Maj. Charles P. Emerson, MC, 5th General Hospital.
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25. Official Diary, Col. Elliott C. Cutler, MC, Senior Consultant in Surgery,European Theater of Operations, U.S. Army.
26. 1st Wrapper Indorsement [sic], Brig. Gen. Paul R. Hawley to The SurgeonGeneral, 26 Aug. 1943, subject: Circular Letter No. 108, OSG.
27. Memorandum, Maj. Michael DeBakey, MC, to Col. Elliott C. Cutler, MC, 15Sept. 1943, subject: Blood Transfusion Unit.
28. Memorandum, Lt. Col. Douglas B. Kendrick, MC, to Brig. Gen. Paul R.Hawley, 17 Sept. 1943, subject: Blood Transfusion Unit.
29. Memorandum, Maj. Richard V. Ebert, MC, and Maj. Charles P. Emerson, MC,to Lt.. Col. Robert M. Zollinger, MC, 23 Sept. 1943, subject: Criticism ofMethod of Whole Blood Transfusion in Circular Letter No. 108.
30. Memorandum, Col. Elliott C. Cutler, MC, to the Office of The SurgeonGeneral, 27 Sept. 1943, subject: Blood Transfusion Unit.
31. Memorandum, Brig. Gen. Paul R. Hawley to The Surgeon General, 12 Nov.1943, subject: Transfusion of Whole Blood.
32. Report, Maj. Richard V. Ebert, MC, to the Chief Surgeon, Services ofSupply, European Theater of Operations, U.S. Army, for attention of Col. ElliottC. Cutler, MC, 6 Jan. 1944, subject: Conference on Whole Blood Transfusion Heldin The Surgeon General's Office, 6 December 1943.
33. Kendrick, D. B., Elliott, J., Reichel, J., Jr., and Vaubel,E. K.: Supply of Preserved Blood to European Theater of Operations. Bull. U.S.Army M. Dept. No. 84, pp. 66-73, January 1945.
34. Memorandum, Capt. John Elliott, SnC, to Chief, Surgical ConsultantsDivision, Office of The Surgeon General, through Director, Army Medical School,1 Feb. 1945, subject: Transportation of Blood from the U.S. to the ETO Blood Bank in Paris.
35. Minutes, Conference on the Preparation of Normal Human Serum Albumin,Division of Medical Sciences, NRC, 5-6 June 1942.
36. Minutes, Conference on Albumin Testing, Division of Medical Sciences,NRC, 19 Oct. 1942.
37. Specification for Normal Serum Albumin (Human) Concentrated. 51-N-015a(INT), 8 Feb. 1943.
