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Plasma Equipment and Packaging, and
Part I. Plasma Equipment and Packaging
Most of the dried plasma used in World War II was put up in a standard packaged devised jointly by representatives of the Army (Capt. Douglas B. Kendrick, MC) and the Navy (Cdr. Lloyd B. Newhouser, MC, USN) and modified from a package devised by Dr. Max M. Strumia (p. 165). These officers were members of a Subcommittee on the Standardization of Dispensing Equipment appointed at the 19 April 1941 meeting of the Subcommittee on Blood Substitutes (1). At the 8 May meeting of the latter subcommittee (2), they were appointed a continuing committee to test blood substitutes and to test equipment for their administration.
There was considerable experimentation before acceptable equipment and packaging were devised and put into production, and occasional suggestions were made for their modification after they had been put into general use.
The first 15,000 packages of dried plasma delivered by the plasma program were processed by Sharp & Dohme, a firm which had had considerable experience in this field before the emergency arose. The components of the unit, consisting of a flame-sealed glass vial of dried plasma, a glass bottle of distilled water, an intravenous needle, and rubber tubing, were rather loosely packaged in a cardboard box. The unit, which was accepted as a matter of expediency, proved unsatisfactory in several respects. Although the flame-sealed ampule (figs. 38A and B) represented the best possible storage technique, it had certain disadvantages: Its shape required a package undesirably large for field use. The neck of the bottle was very fragile, and breakage frequently occurred at the point at which the stopper was inserted. Also, the rubber stopper could very easily be pushed down into the ampule when the dispensing needle was inserted as well as when water was added to reconstitute the plasma. Since these accidents were estimated as likely to occur in about 10 percent of packages of this type, consideration was given to other models. A later proposal that the components of the Sharp & Dohme unit be put up in cellophane bags was not considered 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 were put up in tin
FIGURE 38.-Types of containers used early in World War II for dried plasma. A. Sharp & Dohme combination vial and ampule. B. Same, after flame-sealed tube has been broken off and removed, leaving rubber stopper in situ: airway (a), giving needle and tubing (b). C. Reichel container (Vipule) for dried plasma, with stopper of sleeve type. D. Same after glass sealing tube was broken and removed and sleeve turned back over broken edges of tube, so that container was converted into a rubber-stoppered vial. Airway (a) and giving needle (b) were then inserted into vial through stopper, as in other apparatus.
cans, but the packaging was so loose that breakage was considered inevitable, especially with a container of this shape and size. The flame-sealed ampule contained 110 cc. of normal human plasma, and the amount could be doubled by double-processing. If plasma were processed twice, however, it lost some of its stability and flocculation of globulin and fibrin occurred when it was redissolved. 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 both frozen and dried plasma, was demonstrated and evaluated. This package occupied slightly less space than the Reichel package. It consisted of:
1. A 400-cc. bottle of distilled water, of hard, noncorrosive glass, with square shoulders.
2. A similar bottle containing 250 cc. of dried plasma, with residual moisture of less than 1 percent.
3. A gum-rubber vaccine type of stopper, about three-fourths of an inch in diameter, containing a glass airway. After a vacuum had been drawn on the plasma bottle, 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 under vacuum. It was thought that with certain modifications this unit would prove acceptable for field use.
There were further discussions on equipment at the 23 May meeting of the Subcommittee on Blood Substitutes (5), including a discussion of the gage of the needle to be included in the set. Tests showed that when a 22-gage needle was used, it took 4 minutes to transfer the distilled water to the bottle containing dried plasma, against 30 seconds when a l6-gage needle was used. Another minute was required for complete solution of the plasma. With an 18-gage needle, the rate of flow was 10-15 cc. per minute. Under pressure achieved by blowing through the cotton-filtered tubes, the entire amount of plasma (250 cc.) could be administered in 5 minutes. It was finally decided that the rate of flow would not be materially increased if a needle larger than 16 gage were used and that it might be difficult to insert a larger needle into the vein.
At this same meeting, it was formally recommended that the recommendations of the Subcommittee for the Standardization of Dispensing Equipment be adopted by the Armed Forces. At the next meeting on 18 July 1941 (6), it was further recommended that deviations from standard equipment be permitted only with the approval of the Field Director, American Red Cross, if they were minor, and only with the approval of the National Institute of Health and the Subcommittee on Blood 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 and package (fig. 39) devised by Commander Newhouser and Captain Kendrick,
FIGURE 39.-Standard Army-Navy 250 cc.-plasma package and contents. A. Front of box. B. Back of box. C. Tops removed from cans of distilled water and plasma, with contents showing and ready for removal. D. Contents removed from cans.
which were modified from the Strumia model, were recommended for adoption by the Armed Forces, and, with only minor modifications in the original model, were used throughout the war. In the development of this package, as in many other efforts, Dr. Strumia, Commander Newhouser, and Captain Kendrick worked very closely together (7).
The completed standard package of dried human plasma (Catalog Item Plasma, Normal, Human, Dried, No. 16088) (8) consisted of:
1. A 400-cc. bottle containing the dried solids obtained from 300 cc. of citrated plasma, evacuated and sealed under 29 inches (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 plasma containers should specify the amount of the original plasma from which the dried plasma had been prepared would have required individual determinations of total protein and was rejected as completely impractical.
The bottle was stoppered with a hood-type rubber stopper (fig. 40) and was equipped with a cloth tape for suspending it in the inverted position while the plasma was being administered.
2. A 400-cc. bottle, with a similar stopper but sealed without a vacuum, containing 300 cc. of sterile, pyrogen-free distilled water.
FIGURE 40.-Stoppers used in blood and plasma program. A. Flange-type stopper used in American Red Cross bleeding bottle: protruding steel tubes (a), to which were attached rubber tubes used to collect blood and as airway. B. Rubber stopper used for plasma and water containers in standard Army-Navy plasma package: sleeve (a), plug (b). C. Stopper used for plasma bottle in situ, with sleeve turned down.
3. Equipment for intravenous administration, consisting of:
a. An airway assembly, consisting of 9 inches of rubber tubing, with a needle on one end for insertion into the stopper and a cotton filter on the other end.
b. An intravenous injection set, consisting of 48 inches of rubber tubing with a glass cloth filter for use during the administration of the plasma. At one end of the tubing was a glass adapter fitted to an 18-gage intravenous needle. At the other end was a short 15-gage needle to be used to connect the intravenous set to the plasma bottle.
The bottle containing the dried plasma, the double-ended needle for adding distilled water to the plasma, and a clamp were placed in a tin can which was evacuated to 25 inches (63.5 cm.) of vacuum and sealed. The bottle containing the distilled water, the intravenous injection set, and the air filter were sealed in another can filled with dry nitrogen. The cans were opened with keys spotwelded to their bottoms. It was not considered necessary to supply alcohol and cotton for skin preparation, since they were standard items of supply.
Both cans were packaged in a tape-sealed, waterproof fiberboard box. It was specified that the tape must be pressure-sensitive; waterproof; 1½ inches wide; with no rubber content, either crude or reclaimed; not white, and incapable of reflecting light; and capable of withstanding severe climatic changes without appreciable deterioration. Paper tape was not satisfactory. Since the cans fitted snugly into the box, a string was placed around them to facilitate their removal.
Instructions for the reconstitution and use of plasma were lithographed on the can containing the plasma. A label on one end of the finished package indicated that the blood from which the contained plasma had been made was furnished by volunteer donors through the American Red Cross. A questionnaire for recording data on the use of the plasma was enclosed in each package. All packages put up after January 1943 bore the warning that the plasma must be used within 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 its procurement. Later, in order to conserve tin, the Navy directed the American Can Co. 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 Pearl Harbor. Meantime, it had undergone extensive testing (7, 9):
1. Six packages were placed in a refrigerator variously, right side 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 opened easily. The water was solidly frozen, but thawed satisfactorily at room temperature, 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 easily opened at the end of an hour. Thawing of the distilled water was accomplished by the methods just described, with equal ease and no breakage.
3. Packages forwarded to the Fleet Surgeon, U.S. Pacific Fleet, were sent out with landing parties and placed under 5-inch (12.7-cm.) and 12-inch (30.5-cm.) guns during firing practice and during dive bombing in the months of May and August 1941. The cans were somewhat battered, but they had retained full vacuum and there was no breakage.
The few complaints received about standard Army-Navy plasma packages were individual and concerned single units. Complaints about the plasma itself, which were also few, are discussed under separate headings.
COMPONENTS OF THE PLASMA PACKAGE
Certain of the components of the standard plasma package require special comment, for one reason or another.
By the spring of 1944, reports began to be received from the Pacific Ocean Areas indicating that the white labels used on the plasma packages and the contained bottles, as well as the gold-colored cans, were serving as excellent targets 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 cans from the box from white to olive-drab.
The difficulties that arose with stoppers were due chiefly to the increasing use of synthetics in their manufacture. Lots from one manufacturer became vulcanized into certain shapes when they were sterilized and, unless they were reused with bottles of precisely that size, they were too loose and had to be discarded. In some lots, the needles seemed to act as plugs. These and other difficulties were eventually eliminated, and several types of stoppers were found satisfactory (fig. 40).
Some manufacturers placed transparent gelatin (gel) caps over the rubber stoppers used on the water bottles, to prevent deterioration of the rubber. The rubber stopper used on the plasma bottle did not need such protection as the can containing it was filled with nitrogen and then vacuum-sealed.
Whatever equipment was used in the administration of plasma, the "Minimum Requirements for Filtered Normal Human Plasma or Serum" drawn up by the National Institute of Health on 25 February 1941 (p. 279) required that filtration be an integral part of the process. The specification had been accepted by the Subcommittee on Blood Substitutes at an earlier meeting (1). It took some time, however, for a satisfactory filter to be devised (fig. 41).
Cloth filters had a number of defects (10). Unless they were constructed so that the cloth did not adhere to the sidewalls of the glass housing, the filtering surface was considerably decreased and the tip of the filter did not act, as intended, as a flow meter. An entirely efficient cloth filter would have been
undesirably large and would have required the use of a cumbersome 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 tightly packed that they acted as baffles instead of filters. Complaints from Attu (12), on the difficulty of placing dried plasma into solution at the temperatures encountered in the Aleutian Islands, were attributed to the filters rather than to the cold; dried plasma could easily be placed in solution at a temperature of 10° F. (-12° C.).
The question of satisfactory filters was discussed in detail at 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 plasma and preserved blood. Others doubted it, even if the filter had an adequate surface. The problem was solved when the changeover to the larger plasma package was made (p. 172) and the glass cloth filter previously used was replaced by a small 200-mesh stainless steel filter. The shortage of stainless steel of the desired mesh created some difficulties initially, and until it could be obtained, 100-mesh stainless steel was used and found so satisfactory that it continued
to be employed. With the introduction of this type of filter, most filtration difficulties ended, though a few were reported on the Normandy beachhead (p. 553) and in the Pacific (p. 598).
Probably the most serious material shortages in the plasma program concerned the tubing used in the recipient sets (14). Part of the same problem was the deterioration that occurred in rubber during long periods of storage, which was inevitable in the stockpiling of plasma. The matter came to a head at the Conference on Transfusion Equipment on 25 August 1942 (13), with the appointment 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 Production Board 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 had many desirable features. When properly prepared, it was nontoxic. It could be used efficiently by experienced technicians. It was useful for the injection of crystalloid solutions. On the other hand, it was not suitable for general use throughout the Army, and since it could be used only once, no saving would be effected in substituting it for rubber.
2. Expendable cellophane tubing prepared by the Baxter Laboratories had been used by the Blood Research Division, Walter Reed General Hospital, Washington, D.C., and it was agreed that it could be utilized if rubber became unavailable.
3. Commander Newhouser had instituted studies with vinyl acetate tubing but had not found it suitable (15). Dr. Strumia and his group, however, believed that this tubing could be utilized 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 the laboratory of the Army Medical School and by a testing board representing both the Army and the Navy resulted in the decision that it would not withstand the rigors of the tropical and arctic regions in which U.S. troops were then stationed. Since dried plasma was not used in military hospitals in the United States, it was not thought practical to substitute cellulose tubing for the equipment then in use.
5. It was generally agreed that latex was the most desirable material for tubing. While it was collapsible, its walls did not adhere to each other, and tubing with a caliber of three-eighths of an inch did not retain air bubbles 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 through 1942, because of the necessity of testing samples before orders could be placed or shipments accepted. Additional delays were caused by failures of processors to follow the specified routine for securing priorities in equipment and materials.
In October 1943, a change in specifications resulted in saving some 50 percent of the latex formerly required for tubing: It was found entirely satisfactory to reduce the inside diameter of the tubing from three-sixteenths of an inch to one-eighth of an inch and the thickness of the wall from one-eighth to one thirty-second of an inch.
In April 1942, the request of Eli Lilly and Co. for additional tinplate to use in cans for the plasma package was refused. On 4 May, at the request of the Army-Navy Munitions Board, a meeting was called, attended by representatives of all processors of dried plasma and presided over by the Navy representative on the Munitions Board (17). Brig. Gen. Charles C. Hillman made the following points:
1. Packages of plasma were subjected to various climatic conditions, ranging from tropical to arctic.
2. Up to this time, no substitute for tin containers for plasma packages had been found. Neither lacquered steel nor plastic was able to retain the nitrogen used in forming the vacuum, which was essential. The present package represented much experimentation by practical engineers. Until an acceptable substitute was found, the use of tin was essential.
3. Contracts about to be let for dried plasma for fiscal year 1943 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 was processed from blood donations given by patriotic American citizens for wounded American soldiers, and the tin requirement was very small indeed compared to the value of the contents of the cans.
It was the consensus of the meeting that The Surgeon General should make representations to NRC for further assistance in procuring the tin requested; that an appeal be made through proper channels to the War Production Board for at least a 6-month supply for present requirements; and that the present packaging be continued while further research was conducted.
At this same meeting, the question of stainless steel in the recipient needle of the intravenous set was also discussed. Difficulties in procurement had arisen about it. It was considered essential to use stainless steel because rubber acted adversely upon steel except in a nitrogen atmosphere. If carbon steel were substituted, it must be expected that a considerable number of plasma packages would be rendered useless by rust, since it was practically impossible to keep moisture entirely out of the cannula of the needle. This would probably make no difference if the plasma were used within a month. If, however, it were not used for 3-4 years, it might make a considerable difference: When plasma was needed, it should be ready for immediate use.
Eventually the tin, as well as most of the other materials needed in the plasma and whole blood programs, was secured, though it required continuous and extended correspondence about even such apparently minor matters as the supply of paper cups (p. 295).
THE LARGER PLASMA PACKAGE
As early as May 1941, the desirability of a larger plasma package was already being considered (2, 5). By this time, it was agreed that if a casualty needed plasma, 250 cc. was not a sufficient dose. It was thought, however, that larger containers might be difficult to carry forward, and there was no doubt
that a smaller amount, given early and far forward, might be more beneficial than a larger amount given later in a clearing station. To avoid procurement delays, the Subcommittee on Blood Substitutes decided to proceed with the production of the smaller package but to make the development of a larger package a subcommittee objective, with Colonel Kendrick responsible for its production.
By November 1942, requests for larger quantities of plasma had led to intensive work on the preparation of new containers. The small size of the unit was almost the only serious criticism of the present plasma package. At the 15 December 1942 meeting of the Subcommittee on Blood Substitutes (15), it was pointed out that the amount of plasma in the present package could be increased 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 was not desirable: The volume of the flask would allow for reconstitution to only twice the isotonic concentration, and the subcommittee had already recorded its opposition to the use of concentrated plasma (p. 275).
2. The 250 cc. of plasma dried separately in two bottles could be poured into a single bottle. The National Institute of Health was opposed to this method because no satisfactory means had yet been devised of making the transfer under aseptic conditions.
3. The amount of plasma dried in the original container could be increased from 250 cc. to 400 cc., which would require lengthening the drying time to 48 hours, an increase of about 50 percent. For the present, this seemed the most practical plan, though it was hoped that in the near future a bottle could be designed which would contain 500 cc. of plasma but would still fit the metal can in use.
Experimental work had shown that by the use of a 750-cc. bottle, 600 cc. of plasma could be dried to a residual moisture of less than 1 percent. By the use of a 9½-inch can instead of the 7-inch can presently in use, 500 cc. of plasma could 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 but would represent the same quantity of plasma as 36 small packages.
To make the change from the smaller to the larger package introduced difficulties in the supply of critical materials (18, 19). All but two of the firms presently processing plasma required material that was critical. Cutter Laboratories listed 14 essential changes, plus 6 others that would be necessary if the amounts of plasma then being pooled were changed. Parke, Davis and Co., which had just achieved production of the smaller packages in excess of 3,000 units per week, was dismayed by the changeover. Its dryers were of the manifold type and it was doubtful that the proposed 600-cc. bottles would fit on them without changes.
The requirements of a single laboratory, Eli Lilly and Co., indicated how serious it was to change specifications for any product during the war. This firm estimated that it would require approximately 5,420 pounds of copper, for which it would ultimately release 3,000 pounds of scrap copper; 50 pounds of brass; 2,500 pounds of iron; 375 pounds of stainless steel; new equipment for measuring temperatures by means of thermocouples; and various accessories, as well as noncritical materials. The highest priority possible would be re-
FIGURE 42.-Large plasma package introduced in 1943. A. Large and small packages of dried plasma. B. Box opened to show contents arid questionnaire. C. Contents removed from cans. D. Large and small cans of dried plasma, and can of serum albumin, to show comparative sizes. E. Large and small bottles of dried plasma and vial of serum albumin. Note texture of plasma after shell freezing and drying.
quired, including priority for larger bottles and cans, if production were not to be delayed. As matters worked out, this company was ready to begin production before any of the other laboratories, and it was given a contract for 2,000 large units as a trial run.
When all estimates had been received from the various processing laboratories, Col. Charles F. Shook, MC, made a blanket priority request 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 begin until 1 July 1943. There were numerous reasons for the delay. The company which manufactured the cans had to make a number of changes in its equipment and, for a 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, since the speed of drying, for physical reasons, was partly a function of the plasma shell, it was found difficult to dry 500 cc. of plasma in a bottle not much larger than a bottle designed to contain half that amount. These various problems were eventually solved, first in the laboratory and then in commercial production. In spite of the preliminary difficulties, the changeover was made with remarkably little trouble, as Colonel Kendrick and Commander Newhouser found 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 end of the war.
From the beginning, the emphasis in the plasma program had been on the importance of conserving critical materials necessary for processing, particularly rubber and metal. The change to the larger package saved about half of the rubber tubing previously used, which amounted to many hundreds of thousands of feet; stainless steel for needles; and other critical material. The larger package also provided twice the amount of plasma in about a third of the space previously occupied by the smaller package, another important consideration in view of the shortage of shipping space.
By the time the larger packages of plasma went into production, medical officers were fully cognizant of the need for larger quantities of plasma for resuscitation-at least 500 cc. was now regarded as the 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 Interior hospitals, it was occasionally needed in both general and station hospitals when emer-
FIGURE 43.-Package devised at Army Medical School for dried plasma supplied to Zone of Interior hospitals. Note that cans were not used. A. Exterior of package. B. Box opened to show contents. C. Contents removed. D. Intravenous set.
gencies arose. It was also distributed to installations not ordinarily supplied with liquid plasma, such as Air Force bases and a variety of smaller installations in which plasma was not used sufficiently often, or in large 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 be used in these installations in the Zone of Interior was developed in the Division of Surgical Physiology, Army Medical School (fig. 43). About 20,000 were produced.
One of the indirect advantages of this package was that it permitted the instruction of Medical Department personnel in the use of dried plasma, even though the packaging differed from that of the oversea supply.
Until almost the end of the war, numerous proposals were made by medical officers and others concerning equipment for plasma and blood, most of the suggestions probably being inspired by the lack of provision in oversea theaters, until late in the war, of equipment for transfusing whole blood. Some of the suggestions were made by physicians of great competence in their special fields, but they could not be considered when materials were in critical supply and procured with difficulty and when machines were tooled for bottles, containers, and other equipment in standard sizes. Letters of explanation and appreciation were written to all who made suggestions.
Part II. Transfusion Equipment for the Oversea Program
U.S. Army medical installations went into North Africa in November 1942 with only the most elementary equipment for transfusion (p. 432). Similarly, U.S. Army units in the European theater had no standard equipment, and the items developed before D-day were chiefly improvised.
The selection and procurement of satisfactory transfusion equipment for hospitals in the Zone of Interior was not a problem. Commercially prepared vacuum-type bleeding bottles and donor and recipient sets, which were reusable, became amply available early in the war. On the other hand, equipment used for transfusion 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 North Africa began to be received in the Office of The Surgeon General, personnel of the Division of Surgical Physiology, Army Medical School, had been investigating the 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 poor surgical risks, even after they had received plasma in large quantities. They must also receive whole blood in large quantities before they could become safe risks for anesthesia and surgery.
2. A blood program to supply whole blood in the necessary amounts would become practical only when an acceptable type of transfusion equipment had been developed, together with satisfactory containers for its transportation. The following criteria must be met:
a. A sterile closed system must be utilized for the collection and storage of blood.
b. A preservative solution must be devised in which blood could be safely stored for 14 to 21 days.
c. A transfusion set must be devised so inexpensive that it could be discarded after a single using. In civilian life, the chief cause of transfusion reactions was the presence of pyrogens in the recipient sets, usually as the result of improper cleansing. Under field conditions, the difficulties of cleaning and preparing collecting and recipient sets would make the use of equipment that was not expendable both impractical and unsafe. The transfusion set must also be so simple that it could be used by enlisted men with a minimum of instruction, the sine qua non, of course, being the skill necessary to insert a needle in the recipient's vein. Dr. (later Lt. Col., MC) Robert C. Hardin had shown that this skill could be readily attained (p. 85).
On 20 January 1941, Col. (later Maj. Gen.) Paul R. Hawley, MC, then in the United Kingdom as an observer, sent The Surgeon General, at the request of the Director General, British Army Medical Services, a model of the apparatus used for blood transfusion in the British Army (20). A description of the apparatus, with instructions for its use, was contained in the training pamphlet on resuscitation. The Director General requested that some consideration be given to the advisability of standardizing this equipment in the U.S. Army. The plan seemed to him to have several advantages:
1. Simplicity and economy of procurement, including the saving of 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 use of the same type of equipment, so that, if necessary, reinforcing technical personnel might be exchanged.
The Director General claimed no superiority for this particular equipment except that all British medical units, including Emergency Medical Service hospitals, were equipped with it, and all personnel had been trained in its use for some time. He would, however, be willing to consider standardizing some other 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 Medical School had made considerable progress. A vacuum bottle had been developed, holding 700 cc., against 400 cc. for the British bottle, and needles and transparent latex tubing had also been developed. The British tubing was opaque. More important, the British bleeding set was not completely closed. In spite of these differences, however, the British transfusion set would probably have been accepted for U.S. use if only it had arrived some months earlier.
DEVELOPMENT OF EQUIPMENT
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 with which blood for transfusions could be collected in medical installations overseas was a beaker. The risk of contamination was present even when the blood was transfused immediately, and this method was totally inappropriate for the storage of blood, though it was quite evident, from the large numbers of casualties expected, that stored blood in large quantities would be necessary to care for them. The present plan was to employ plasma exclusively forward of evacuation hospitals (when the Mediterranean Blood Bank went into operation 10 months later, whole blood was employed in field hospitals), but at that, 50,000 transfusions might be necessary for each 100,000 casualties.1 The bottles necessary for this amount of blood would occupy, it was estimated, 6,100 cu. ft. of shipping space.
To make up for the lack of standardized equipment and the shortage of shipping space, the following proposals were made:
1. In evacuation hospitals, all transfusions should be given with fresh blood, one reason being the lack of refrigeration for storage of blood; the single refrigerator provided was usually filled with biologicals.
2. At general and station hospitals, at which level donors could be more easily procured, blood should be collected and shipped forward as necessary. It would 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 physiologic salt solution as soon as they were used and would be autoclaved with the rubber tubing 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 ample refrigeration, 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). Instructions were given in it for the transfusion of fresh whole blood in general hospitals in oversea theaters within 4 hours after it had been collected and for the transfusion of stored blood, to be collected by a closed system and used within 7 hours after it had been collected (fig. 45). Colonel Kendrick's concurrence in this circular letter was most reluctant but, under the circumstances, there seemed to be no other choice.
FIGURE 45.-Collection of blood in oversea theaters by use of empty sterile plasma bottle contained in large standard Army-Navy plasma package and usually discarded. A. Distilled water being transferred from bottle in standard package to plasma bottle. B. Glass beads and sodium citrate solution in rubber-stoppered vial requisitioned from United States. Beads act as filter. C. Stopper of plasma bottle removed, so that beads and citrate solution can be poured into it. D. Beads and solution being poured into plasma bottle.
FIGURE 45.-Continued. E. Plasma bottle ready for collection of blood. F. Bleeding by gravity, with stopper of plasma bottle removed. G. Insertion of needle into donor's vein. H. Donation nearing completion.
FIGURE 45.-Continued. I. Detachment of needle from vein. J. Replacement of sterile stopper on bottle. K. Alternative technique of bleeding under closed system, accomplished by pulling vacuum on plasma bottle. L. Insertion of needle in donor's vein.
FIGURE 45.-Continued. M. Other end of donor set connected to plasma bottle by insertion of needle through stopper. N. Completion of donation. O. Detachment of needle from vein. P. Blood ready for transfusion. Bottle contains blood, sodium citrate, and glass beads.
The ad hoc Committee on Transfusion Equipment appointed at the 9 April 1943 meeting of the Subcommittee on Blood Substitutes (21) made the following recommendations at the 13 May meeting of the subcommittee (23):
1. That the expendable Army-Navy package for dried plasma (p. 165) be used for whole blood transfusions in medical installations in theaters of
operations. When the dried plasma had been reconstituted, the empty distilled water bottle would provide a closed receptacle which would be sterile and free from foreign material. The intravenous and airway assemblies used for plasma infusion could be salvaged for the administration of blood by cleaning them immediately.
2. That the anticoagulant solution with glass beads used for filtration be packaged in individual vials, ready for immediate use.
3. That facilities for preparing and sterilizing equipment for transfusion and storage of whole blood be made available for general hospitals overseas.
These recommendations, it was emphasized, implied supervision of the entire process by personnel experienced in the techniques used in the preservation and transfusion of whole blood.
This plan was frankly an expedient, and an unnecessary one at that. At this time (May 1943), vacuum bottles were available, and a completely satisfactory closed system could have been used for the collection of blood (fig. 44). The equipment was just as good as any used later for the oversea airlift. The shipment of these containers overseas, however, was not permitted, and makeshift arrangements 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 equipment necessary for transfusion would be available in large quantities in all oversea medical installations.
2. This equipment lent itself to either open or closed transfusion.
3. It was interchangeable with the equipment currently employed in the administration of crystalloid solutions.
4. The cleaning of containers would be reduced to a minimum.
5. Shipping space would be conserved, since the necessary equipment was already overseas and considered expendable, its original purpose having been fulfilled. It could therefore be considered expendable after being used for transfusion.
DESIGN OF FIELD TRANSFUSION UNIT IN EUROPEAN THEATER
Development of Model
Statement of the problems-Early in 1943, when it became evident that there were no official plans and no standardized equipment for the use of whole blood 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 their attention to a number of problems which obviously
required solution before the use of whole blood in forward installations would become practical (24):
1. Designing a transfusion set that would be simple, sturdy, and easily operated; that would offer a minimum of technical difficulties and complications; and that could be used repeatedly, so that an excessive number would not be required.
2. Devising a method of cleaning and sterilizing transfusion equipment that would be rapid, efficient, and safe; that would require no source of heat; and that would involve the use of only those materials provided with the set.
3. Restricting the materials used in the construction of sets and assembly of kits exclusively to those available in the theater of operations.
4. Incorporating the transfusion equipment, with all necessary appurtenances, into compact units or kits that could be packed readily and transported easily.
5. Providing a method of selecting blood donors that would reduce to a minimum the risk of transfusion reaction's due to group incompatibility.
First model.-The basic unit of the set designed 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 rubber components were excellent.
This model was constructed with a long glass tube extending to the bottom of the flask. To this long tube was connected an 18-inch piece of rubber tubing, fitted with a glass adapter for a Luer needle. The blood was collected through this tubing. A short piece of glass tubing inserted through the stopper of the bottle served as an airway. Suction was applied to the airway to expedite the collection of the blood. At the end of the donation, sodium citrate solution was introduced through the long tubing.
When the blood was used, air was introduced into the airway by means of a blood pressure bulb, to force the blood out of the flask and into the recipient's vein.
FIGURE 47.-Evolution of donor bottle in Ebert-Emerson transfusion set. A. First model. B. Second model: Rubber stopper with two holes (a); medicine dropper, cut to 11/8 inches (b); glass tube, 10-mm. diameter, 8¼ inches long (c); medicine dropper (d); gum rubber tube, 14 inches long (e); adapter for Luer needle (f); gum rubber 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 set constructed with a larger caliber (10-mm.) glass tube, into which a medicine dropper was inserted (fig. 47B). With this model, which utilized a single tube connection for both collection and transfusion, the blood flow during the donation could be observed.
Third model-A third model (fig. 47C) was constructed when it was found that the long rubber tubing which was issued with each package of dried plasma, and which incorporated both a filter and an adapter, could be connected to the short glass tube and replace the airway. When the flask was inverted and suspended by its bale, blood could be injected by gravity, the venesection tube serving as an airway (fig. 48). This was a convenient arrangement, since plasma was used in sufficient amounts to supply all the rubber tubing necessary. The tubing required no preparation before use and could be discarded after the transfusion.
FIGURE 49.-Higginson enema syringe adapted for suction in Ebert-Emerson technique of blood collection: sphygmomanometer bulb (a); inlet valve (b); rubber tube, 12 inches long (c); rubber tube, 3 inches long (d); outlet valve (e); and medicine droppers (f).
This model proved so satisfactory that the pressure technique, which had been devised chiefly to eliminate the cleaning and sterilization of long lengths of rubber tubing, was abandoned. In the final model, the long glass tube, which was fragile and difficult to construct, was also abandoned.
Several other changes were also made. The modified blood pressure bulb originally used to expedite the donation and the introduction of the sodium citrate solution had not proved particularly satisfactory; it was replaced by a Higginson enema syringe (fig. 49). Glass beads were added to the flask when it was found that small clots were sometimes clogging the needle. When the flask was inverted, clots and fibrin particles were removed as the blood filtered through the beads.
Anticoagulant-When the Ebert-Emerson set was first worked on, early in 1943, no sterile sodium citrate solution was available in U.S. supply depots, and British sources were used for it. Later, it was found that sodium citrate was present in sufficient excess in U.S. dried plasma to provide the amount of anticoagulant required in the field transfusion set. After numerous tests of potency, it was found that one part of reconstituted dried plasma prevented the clotting of two to three parts of blood; if one unit (300 cc.) of reconstituted plasma was aspirated into the collecting bottle before 500 cc. of blood was collected, the blood would not clot. The anticoagulant problem was thus
solved provided that (1) only group O donors were used in the field and (2) the recommendation was followed that plasma be given routinely with whole blood.
Cleaning and sterilization-Cleaning transfusion equipment in the field presented special difficulties, because running water would not be available and water alone was not sufficient for cleaning the set. Experiments showed that the Ebert-Emerson equipment could be cleaned rapidly and thoroughly if some alkaline detergent, such as a compound used for dishwashing, were used in aqueous solution and pumped into the set and through the tubing with a Higginson enema syringe. The alkaline detergent solution completely dissolved the lipoid and protein components of the blood insoluble in neutral solutions. Water from any available supply was used for rinsing, followed by a final rinsing with the sterile, pyrogen-free water provided for reconstituting plasma; a small amount of it was reserved for this purpose (fig. 50).
Sterilization was originally a major problem. Autoclaving takes a considerable time, and facilities for it were often lacking in the field. Sterilization by boiling was unsatisfactory for two reasons, (1) that smaller sterilizers could not accommodate the set and larger sterilizers were difficult to heat from available sources, and (2) that the large amounts of organic and inorganic matter in the water contaminated the sets.
The sterilization problem was settled by introducing an ounce of 80-percent alcohol into the set immediately after it was cleaned and leaving it in situ until the set was used again. Insertion of the adapter into the airway created a closed system, and inverting the bottle distributed the alcohol to all parts of the set. There were no reactions when this method was used, and experimental studies showed that sterilization could be accomplished by it in less than 20 minutes.
Transfusion kit-The field medical chest, which was originally used as a container for the field transfusion kit, proved too bulky and heavy to be practical. The small wooden box next constructed for this purpose introduced problems of manpower and supply and proved not sturdy enough for field use. Eventually, the ammunition box used for 265 rounds of .50-caliber machinegun cartridges was adapted for this purpose (fig. 51). It was painted green, with a caduceus on the side, and was transported by the handle on the top. Each box contained three transfusion bottles, 20 ampules of 2.5 percent sodium citrate solution, needles for collecting and giving blood, Novocain (procaine hydrochloride), typing sera, two Higginson enema syringes, alcohol, a cleaning compound, pus basins for washing the sets, and a small Luer syringe.
A hand centrifuge was also provided for field use; this was an essential item, because the errors known to exist on identification tags required group testing before the blood was used, even though only group O blood was employed. Crossmatching was considered unnecessary.
Controversy Over Acceptance of Field Transfusion Unit
Before commenting on the controversy which arose concerning the use of the Ebert-Emerson field transfusion units, several points should be made clear:
1. There had been no previous provision in the European theater for transfusion in Army medical installations. The confusion in the theater was evidenced in December 1943, when a general hospital was informed, in response to its inquiry, that it would have to improvise both giving and receiving sets. It was also suggested that some of the hospital blood bank personnel visit the 5th General Hospital and study the field transfusion unit devised 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, that standardization of a portable transfusion unit for combat areas must be undertaken in view of the reports from North Africa and Italy of the large amounts of whole blood being used in the routine of resuscitation. He had been informed by Brigadier Lionel E. H. Whitby, RAMC, in charge of the British Army blood program, that in British medical installations, the use of wet plasma had been practically abandoned in favor of whole blood.
On 22 September 1943, Colonel Cutler (25) again wrote General Hawley of the urgent need for field transfusion sets. He described the Ebert-Emerson set, listing its advantages and pointing out that it had been approved by Brigadier Whitby; by Captain Hardin, who had been working with the British Central Blood Bank at Bristol for the past 9 months (p. 470); and by members of the Professional Services Division, Office of the Theater Chief Surgeon. He recommended that this set be put in production at once for transfusion teams to use for the transfusion of severely wounded casualties with blood secured from lightly wounded casualties. He also recommended that the description of the set be sent to the Office of The Surgeon General.
3. Communications between the Office of The Surgeon General and the European theater were not always rapid, and the circular letter (No. 108, 27 May 1943, (22)) in which instructions were given for improvised equipment for blood transfusion did not reach the United Kingdom until the Ebert-Emerson set had been devised, modified, and put into its final form. On 26 August 1943, General Hawley pointed this out to The Surgeon General (26), also making it clear that local theater action had been necessary in view of the lack of any formal plan or standardized equipment for transfusions of whole blood.
4. The safety of the equipment devised had been tested by numerous transfusions on volunteers, the first transfusion with each modification 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 to accept the Ebert-
Emerson field transfusion unit on the ground that it was in conflict 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 of utilizing equipment already on hand, which would require only minimum sterilization (intravenous tubing, needles, and filter). Moreover, the plans at this time did not envisage the use of whole blood forward of hospitals in which adequate autoclaving facilities would be available for sterilization of the sets.
Two specific criticisms of the Ebert-Emerson technique were made:
1. The method of sterilization was open to question. It was doubtful that rinsing with 80-percent alcohol would insure a sterile, pyrogen-free container.
2. Experience had shown that it was much safer to have a filter in the intravenous line during transfusion, to prevent the introduction of small blood clots into the recipient's bloodstream, with the risk of embolism. When blood was collected or administered by pressure bulb, it was also desirable to have an air filter in the line, to reduce the possibility of airborne contamination.
On 23 September 1943, Major Ebert and Major Emerson sent Lt. Col. Robert M. Zollinger, MC, Senior Consultant in General Surgery, European Theater of Operations, U.S. Army (29), a memorandum in which they reiterated that with the techniques which they had employed, they had never had a pyrogenic reaction. They had also had no difficulty with clots when they did not use filters, and they doubted that a clot which could pass through an 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 the British Army transfusion bottle instead of the Baxter bottle in the field transfusion unit. The British bottle was already in use in the theater for stored whole blood, and it might be desirable to standardize all theater transfusion methods. More important, Baxter bottles were in increasingly short supply, and their total unavailability later might constitute an insoluble problem.
2. The transfusion techniques outlined in Circular Letter No. 108 provided for transfusions only in fixed hospitals. The Ebert-Emerson unit had been designed, at the expense it was granted, of certain traditional refinements, to meet the need for blood in more forward installations, a need repeatedly stressed in information from the Mediterranean theater.
Major Ebert and Major Emerson objected to the policies and procedures set forth in Circular Letter No. 108 for the following reasons:
1. Many of the materials specified for use were not always available, especially in forward installations. The 500-cc. plasma unit was not available in the European theater. Collection of blood in the 300-cc. distilled water flask was not practical. After 50 cc. of sodium citrate solution had been introduced into it, the amount of blood that could be collected would scarcely be worth the effort. The intravenous fluid flask used in the Ebert-Emerson set had a capacity of over a liter. Other items lacking included 50-cc. vials of sodium citrate solution with glass beads (Item No. 14306); stainless steel mesh filters in glass housings (Item No. 36099); and 15-gage needles of the 2-inch hose connector type (Item No. 33578) (fig. 52). Neither glass beads nor mesh filters (considered unnecessary refinements) were required with the proposed field unit.
2. The open technique recommended in the circular letter was likely to introduce appreciable amounts of foreign matter into the blood, especially when transfusion was necessary in dusty or sandy atmospheres. The Ebert-Emerson technique was a closed system, in which there was no risk of contamination in the receiving flask.
3. The crossmatching recommended in the circular letter was not feasible with the equipment provided for the field. The safest plan was to use O donors exclusively, rechecking their blood group by the high-titer, dried rabbit sera provided by the Army. Donors with weak A2-agglutinogens were more likely to be identified by this technique than by crossmatching with the blood of recipients with anti-A agglutinins in low titer.
4. The airway recommended in the circular letter would cause the 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 flow would be further impeded by the venous constriction often present in casualties in shock, whose response to transfusion often depended upon the volume and speed of transfusion. The proposed field unit had been designed for the administration of blood under pressure, and the model finally evolved did not require suspension of the bottle.
On 27 September 1943, Colonel Cutler (30) transmitted this information through channels to the Office of The Surgeon General, expressing himself as in complete sympathy with it. He also emphasized the importance of using whole blood in forward installations, as shown by the data being received from the North African theater, and the urgency of constructing some sort of transfusion apparatus in the European theater with the materials available there.
Conference of 6 December 1943
Major Ebert was sent to the Zone of Interior on temporary duty in the late fall of 1943 (31) and attended the conference on blood transfusion equipment held on 6 December 1943 (32), in the Office of The Surgeon General. The frank discussion possible clarified many of the issues which 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 recipient set.
3. The packing of all the components of the transfusion unit in a single unit in a single compact package, for their efficient use. Six units were packaged in each ammunition box used for this purpose.
Major Ebert pointed out that until 500-cc. plasma units were supplied to the theater, it was impossible to carry out the recommendations in the 27 May 1943 circular letter. He was told to request the theater medical supply officer to requisition a sufficient number of the larger plasma packages for all units, so that the distilled water bottle could be used for transfusion.
Since the transfusion equipment then in development in the Zone of Interior would probably not be ready for shipment until about 1 February
1944 (it was not received in the European theater until April 1944), it was agreed that the field transfusion unit devised by Major Ebert and Major Emerson should be put into production and used until expendable bottles and recipient sets could be supplied. It was suggested that he ask the theater supply officer to requisition the new equipment promptly, so that it could be shipped as soon as it became available. Major Ebert requested, and was given, samples to take back with him, so that preliminary training with the new equipment could be begun.
EXPENDABLE TRANSFUSION EQUIPMENT
The expendable equipment eventually provided for oversea theaters consisted of a donor set and a giving set, each put up in sealed aluminum foil containers (33).
Up to late 1944, the blood bank at the 152d Station Hospital in 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 suction applied to the airway by a hand pump. When bottles were finally sent to the European theater from the Zone of Interior, the commercially available vacuum bleeding bottles (fig. 44, p. 178) were selected for several reasons:
1. They had been found extremely satisfactory over the previous 4 years at the Army Medical School, in the processing of liquid plasma for Zone of Interior hospitals. Blood banks in general hospitals had also used them with equal satisfaction.
2. Their use provided assurance of sterile, pyrogen-free blood and other solutions.
3. They were economical as well as safe. They were so inexpensive, in fact, that it would not be economical to return them by cargo ship or plane to the Zone of Interior for reuse. This was an important consideration. The return of needles, tubing and filters from the Continent after D-day was so slow and incomplete that it was the chief limiting factor in sending whole blood to the Continent (p. 551). By the end of June, 7,000 sets were still missing in First U.S. Army scheduled returns. These difficulties continued until blood began to be received from the Zone of Interior the last week in August.
4. Since the bleeding bottles would be used only once and would replace locally prepared equipment, they would conserve the personnel used in each installation to clean bottles and prepare solutions. When Capt. John Elliott, SnC, reported on his visit to the blood bank at Salisbury in January 1945, one of his comments was that 25 to 35 percent of bank personnel were engaged in the preparation of nonexpendable equipment (34). The change to the vacuum type of disposable bottles was therefore even more important than it might seem superficially.
The disposable donor set consisted of:
When the set was used, the clamp was placed on the rubber tubing near the 16-gage needle and tightened sufficiently to close the lumen. The needle was inserted through the thickest portion of the rubber stopper of the vacuum bottle. The 17-gage needle was inserted into the donor vein. The clamp was then loosened and was adjusted as necessary to control the rate of flow.
Although the donor set was considered expendable, it could be used five or six times if facilities and personnel permitted proper cleansing and sterilization.
Recipient (Giving) Set
The giving set consisted of (fig. 53):
The connector at one end of the glass filter housing was used to engage the bleeding bottle at the free hole. The other end was closed by the perforated rubber stopper.
The glass connecting tube was passed through the hole of the stopper and attached to the rubber hose. The 18-gage intravenous needle was attached to the other end of the hose. The Monel metal filter in the glass housing was inserted and held in place by the rubber stopper at the lower end of the housing. The filter was inverted, so that blood ran into it, thus increasing its filtration surface by about a third. The metal airway tube, after insertion, provided an outlet for the glass airway tube.
When this set was used, the glass housing was completely filled, so that there was no break in continuity of the bloodstream between the housing and the bottle. An adequate head of pressure, extending from the top level of the blood in the bottle to the lowest level of the tubing, was thus assured. Thus precaution was essential to provide a steady flow of blood into the vein.
It was obviously impossible to supply equipment for the European theater that would be at the same time inexpensive, complete with all refinements, and acceptable to everyone. The expendable set finally selected had an adequate
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.
filtering mechanism and was so constructed that it was capable of use without difficulty not only by medical officers, many of them without special experience in this field, but also by the nurses and enlisted men who would have to administer most of the blood. It did not provide either a drip indicator or a Luer-tip glass connector for the needles. Both were regarded as unnecessary refinements. The lack of the indicator was compensated for by maintenance of a steady head of pressure. The rate of flow was automatically controlled by the gage of the needles used, which did not permit blood to be introduced into the vein rapidly enough to overload the circulation. A simple means of determining that blood was running into the vein was to place a drop of water or alcohol on the airway outlet. If it was sucked up into the glass airway tube, it was evident that suction existed and that blood was flowing out of the bottle.
Part III. Albumin Packaging
The package devised by Commander Newhouser and Colonel Kendrick was demonstrated at the Conference on the Preparation of Normal Human Serum Albumin on 5-6 June 1942 (35), and again at the Conference on Albumin Testing on 19 October 1942 (36). The corrugated fiberboard package (37) was small and compact, and had the added advantage, for Navy use, that it floated (fig. 54). Each package contained the material and equipment for three injections. Instructions for use of the albumin were lithographed on the cans.
The components of the package were:
100 cc. of 25-percent normal human serum albumin prepared
from human plasma.
The metal can used in the Army-Navy serum albumin package was a standard Navy item, used for the priming charge of explosives. There was therefore no delay in its procurement. Later, in order to conserve tin, the can was electroplated. The ends were made of bonderized steel.
Note.-As a matter of convenience, special aspects of equipment are further discussed under theaters of operations and elsewhere.
FIGURE 54.-Standard Army-Navy serum albumin package. A. Exterior of box. B. Box with cover removed to show 3 cans it contains. Each can contains 100 cc. of human serum albumin (25 percent) with equipment for its administration. Contents of each can equal a 500-cc. shock unit of plasma. C. Contents removed from can. Decal on can is instructions for administration of serum albumin by equipment shown. D. Serum albumin equipment on left, which was adopted, in contrast to equipment on right, which was originally devised (for noncombat use) but which would have been hard to package and keep sterile. Had this equipment been adopted, administration would have had to be quickly by hand, whereas equipment adopted permitted administration by gravity.
1. Minutes, meeting of the Subcommittee on Blood Substitutes, Division of 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 May 1941.
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 of Deficiencies in Packaging of Human Plasma.
5. Minutes, meeting of Subcommittee on Blood Substitutes, Division of Medical Sciences, NRC, 23 May 1941.
6. Minutes, meeting of Subcommittee on Blood Substitutes, Division of Medical Sciences, NRC, 18 July 1941.
7. Strumia, M., Newhouser, L. R., Kendrick, D. B., and McGraw, J. J.: Development of 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 Standard Army-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 of Medical 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 of Operations on Attu.
13. Minutes, Conference on Transfusion Equipment and Procedure, Division of Medical Sciences, NRC, 25 Aug. 1942.
14. Memorandums and correspondence concerning tubing for plasma sets, 11 Sept. 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 of Medical 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, 24 Mar. 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 of Medical Sciences, NRC, 9 Apr. 1943.
22. Circular Letter No. 108, Office of The Surgeon General, U.S. Army, 27 May 1943, subject: Transfusion of Whole Blood in the Theaters of Operations.
23. Minutes, meeting of Subcommittee on Blood Substitutes, Division of Medical 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.
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 Surgeon General, 26 Aug. 1943, subject: Circular Letter No. 108, OSG.
27. Memorandum, Maj. Michael DeBakey, MC, to Col. Elliott C. Cutler, MC, 15 Sept. 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 of Method of Whole Blood Transfusion in Circular Letter No. 108.
30. Memorandum, Col. Elliott C. Cutler, MC, to the Office of The Surgeon General, 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 of Supply, European Theater of Operations, U.S. Army, for attention of Col. Elliott C. Cutler, MC, 6 Jan. 1944, subject: Conference on Whole Blood Transfusion Held in 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 Consultants Division, 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.