Industry's contribution to the development of renal care.
When asked to contribute to this issue of the ANNA Journal celebrating the 20th year of the founding of ANNA, I was moved because it is also my 20th year in dialysis and a memorable occasion for me.
A lot has happened in the past two decades. I have seen dialysis grow from the days when patients were selected for dialysis by their ability to pay, their age, or their medical complications. I remember the welfare director of a large eastern state making the decision not to allow home dialysis because he was afraid that others would want home dialysis and that it would become too costly.
We were able to change the attitude of the welfare director through the perseverance of a dedicated nurse and the personal plea from the patient and his family. We had to prove to the state agency that home dialysis was cost-effective and in the patient's best interest.
This was not just a victory for industry, it was an acknowledgment that all parties involved in treating renal failure must work together to achieve change and medical progress. In this chronological review of industry's contribution to the development of renal care, I will describe a number of instances where this team approach was necessary in order for progress to be possible.
Early Attempts at Removing Toxic Substances
Others have referenced the earliest written evidence of attempts to remove toxic substances from the body of man in ancient times by the use of purgatives, hot baths, and oral medications such as beer and other diuretics. The physician at that time probably represented industry because he was the one who prepared the various potions or decided on the course of therapy. The contractors who built the hot baths were also third party to the removal of these toxic waste products. There is no doubt that these ancient treatment approaches were industrial endeavors because the cost of these procedures and the supplies have been noted by the ancient scribes.
Other forms of treatment, such as blood letting and the use of leeches, survived to recent times. It is interesting to note that the American Journal of Nursing recently published an article on how to use the leech in the care of patients who are having problems with blood circulation after surgery. Ancient practitioners were quite perceptive in choosing their therapy techniques.
Christopher Wren, the famous architect, appears to be the first to demonstrate a method of gaining access to the blood stream in the early 1600s. Others would have to solve the problem of blood compatibility. Blood exchanges, cross circulation, or the use of animal blood were tried with unsatisfactory results.
Latta and O'Shaughnessy in England made a historic discovery during the cholera epidemic of 1838. They instilled an isotonic solution into the patient's blood stream. These solutions were boiled in order to keep them free of bacteria. They were able to treat cholera successfully for the first time.
It became obvious to these early investigators that many of the body's problems could be solved if the blood could be properly treated, replaced, or somehow have the toxic substances selectively removed.
Early Diffusion Devices
Abel, Turner, and Reentry (1914) were the first group to actively demonstrate that substances could be selectively removed from the blood in 1912. Their goal was not to develop an artificial kidney as we know it today, but to be able to selectively remove substances from the blood so that specific medical conditions could be studied and treated. This group is most interesting because they could not have performed their experiments without the help of some very unusual industrial suppliers.
Abel relates how it was necessary for Reentry (see Figure I) to attend classes at a nearby glass factory so that he could learn how to blow glass and construct the "Vividiffusion" device, cannula, and other glass components necessary for the experiments. Abel et al. (1914) made note that they had to order their leeches from "Hynson and Wescott" for $25 per 100. These leeches were specially harvested from Yugoslavian swamps and Abel used them for his anticoagulant. It is interesting to note that Abel discontinued his experiments with the diffusion device because World War I had cut off his supply of leeches, so he went on to study other areas of interest.
Abel had received support from the Eli Lilly Company because he had convinced them that he could isolate the insulin crystal. The "Vividiffusion" device, it was hoped, could help him do it. He did this in 1926. He thought that his experiments would lead to an answer for the treatment of diabetes. When he found out that Lilly was interested in commercializing this work, he refused to work with them further. Drs. Ranting and Best in Canada continued insulin development and received the recognition that their work deserved. This is possibly the first example of industry funding a development project where dialysis principles were well defined for later investigators to expand.
The memorabilia of the Abel group are still at Johns Hopkins in Baltimore, Maryland. It is fortunate that the Eli Lilly Company had the foresight to film one of Abel's lectures. It is one of the very earliest examples of sound on film, and Abel narrates his early work and notes his disappointment at not being able to apply his technique clinically.
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Use of Membrane to Remove Substances from Blood
William Thalhimer, MD (see Figure 2), from Michael Reese Hospital in Chicago, was looking for ways to separate blood components and to concentrate plasma. He was aware of the difficulty that others had in manufacturing membrane by using colloidin material. He was able to obtain some sausage casing from the Visking Corporation in Chicago. This membrane was very inexpensive, strong, and had very good transport capabilities. His experiments were critical in pointing out the value of this membrane and diffusion principles to other investigators.
This is another example of how a scientist adapted materials that were not designed for their ultimate application but that worked very well for medical purposes. The medical market was so small compared to the commercial market that Visking had never developed the membrane for medical purposes.
The Beginning of Contemporary Dialysis
Dutch physician Willem Kolff, MD, was the first to convince industry that there was a future in dialysis. He had attempted to duplicate the work of Thalhimer in humans, but was unable to overcome equipment problems. He then convinced The Berk Enamel Company from Kampen, Holland (see Figure 3) that he needed their help and that there was a true medical need for a development project like this. The first devices were built under the pressure of World War II conditions. They were mechanically sound and they did demonstrate that a dialysis machine could overcome the problems of kidney failure. After the war, some of these machines were shipped to Canada, New York, and England. They used the Visking membrane and they demonstrated to the medical community that hemodialysis was a reality. Kolff came to the United States and helped to initiate the first dialysis at Mount Sinai Hospital in New York City in 1947. Dr. George Thorne and Dr. John Merrill, MD, were in attendance, and they decided to start a program in Boston that would support their proposed transplant program.
Industrial Development Of Hemodialysis
The Boston group was guided by Dr. Kolff in modifying his original rotating drum design. A machinist, Edward Olsen, who worked for Dr. Carl Waiters at the Peter Bent Brigham Hospital in Boston (now Brigham Women & Children's Hospital), began building the Kolff Brigham Kidney (see Figure 4). Olsen would eventually set up the Edward Olsen Company to manufacture the machines that would be the base for all hemodialysis development in the early 1950s.
Walters and Olsen consulted with the Brunswick Corporation. They adapted the plastic that is used in the bowling ball to be used as bushings for connecting the blood lines to the membrane. The membrane was rotated while the blood line remained stationary, so a split coupling was required to allow for this rotation without allowing the blood to leak out of the circuit. This was a major advance over the metal coupling Kolff had used on his original machine. They had found a biocompatible material that could be easily manufactured and autoclaved. This material was so compatible that one of the attending surgeons would use it for the production of the first heart valve, with the help of the Brunswick Corporation. This system was effective, but it was so cumbersome and time-consuming that its application was limited. Runs were long. Arterial and venous access was via repeated cutdown procedures and blood priming was required. The Kolff Brigham Artificial Kidney was the first "off-the-shelf" hemodialysis system that was available to the renal care community.
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This artificial kidney system was used by the U.S. Army in Korea to treat the war casualties and to train military physicians in the use of this device for acute renal failure. This machine was then purchased by a number of centers around the world for use in treating acute renal failure. In most cases, the operators of this device were trained by the Brigham group in Boston.
Other Hemodialysis Equipment Development
In the early 1950s, an employee of the Allis Chalmers Company was diagnosed as having acute renal failure. An executive of the company asked why a hemodialysis machine was not available for treating the employee. The reply was that they were too expensive and that they were in short supply. The concerned executive decided to produce the machine (see Figure 5) at the Allis Chalmers facility and to make it available to the medical community. They engaged Dr. J. Van Noorwijk, who had been an associate of Dr. Kolff's during the early days of the development of the rotating drum kidney. He suggested a number of modifications and also developed the protocol for its clinical use. Allis Chalmers set up a group that would accompany the hemodialysis machine when it was ordered by a center. They would not only install the device, but would also teach the center how to use it clinically. They sold over two dozen of these devices around the world before the demand diminished and the project was abandoned. The objection to the Allis Chalmers machine was the complexity and the cost.
Dr. John Merrill, at the Peter Bent Brigham Hospital, made some suggestions to the Westinghouse Company about manufacturing a more compact hemodialysis machine. They adopted the Awall vertical drum design and they made it as integrated a system as possible. The shortcomings of the system (see Figure 6) were that it was time-consuming to set up and it was limited in efficiency because of the limited membrane surface area. Three of these devices were manufactured in the early 1950s and used clinically before it was decided that the demand did not warrant continuing the project.
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In the early 1950s, another group at the Metropolitan Hospital in New York City clinically evaluated the Kirwin Lowsley (see Figure 7) plate dialysis machine. The concern again was that it was a time-consuming process to use the machine and that there was limited application because it was to be used for acute dialysis only. The use of this kidney was eventually abandoned.
The First Disposable Artificial Kidney System
Willem Kolff had abandoned the rotating drum concept because he saw that ease of use and expense would limit the application of the system. Kolff accepted a position at the Cleveland Clinic and continued his effort to develop a more practical artificial kidney. With the help of Dr. Bruno Wattschinger, he modified the coil (see Figure 8) version of the Inouye and Ingelberg artificial kidney. They designed two blood paths to reduce the internal resistance to blood flow and sterilized it. They now had a prepackaged, presterilized, and ready-to-use artificial kidney.
Kolff visited a number of medical companies that he thought might have an interest in the clinical application of hemodialysis. These companies did not see the potential for this radical treatment in the early 1950s. Fortunately, Kolff met with William Graham, who was then the president of Baxter Laboratories. Baxter was a relatively small manufacturer of specialty products for the hospital market. Baxter's focus was on disposable products using plastic components and devices for intravenous (IV) use. Baxter, at that time, was the largest manufacturer of IV and blood collection products.
Graham saw how the artificial kidney could fit into his medical specialty product line because of his industrial interests and his educational background in chemistry.
Graham and Kolff decided to collaborate on an artificial kidney system, which was made available for sale on October 30, 1956. It is interesting to note that the price of the machine was $1,000 and the disposable kidneys were $53 each. This was expensive for the time and limited its use. The other limiting factor was that it could only be used for the treatment of acute renal failure. In addition, there were very few trained medical groups that knew how to use the system. As a result, hemodialysis continued to be a medical curiosity that was practiced by a very few institutions in the medical community.
There were a number of centers that purchased the system but never used it. There were others that were offered the system at no charge but refused it because they did not see the benefit of hemodialysis. Graham became discouraged by the lack of progress with the artificial kidney, but he continued to pursue it because he felt strongly about its value to the medical community.
The Breakthrough in Acceptance Of Hemodialysis
The single greatest barrier to the wide use of hemodialysis was that access to the blood stream could not be maintained over a long period of time. Once the access sites were exhausted on the patient, dialysis was discontinued.
Dr. Balding Scribner, MD, from the University of Washington, collaborated with Wayne Quinton to develop the teflon arteriovenous shunt (see Figure 9). This was the first permanent access to the blood supply that allowed the transition from acute to chronic dialysis. For the first time, a patient with nonfunctioning kidneys could be maintained on chronic hemodialysis. This milestone occurred in 1960 when Clyde Shields was the first patient to demonstrate that a patient without functioning kidneys could be maintained on hemodialysis for an indefinite period of time.
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The medical community's interest in chronic hemodialysis developed rapidly in the 1960s. Quinton Instruments was established in Seattle, Washington, to provide access devices that were needed by the dialysis community.
The Sweden Freezer Company was asked to develop a system to keep the dialysis solution cold so that bacteria could be controlled. The early batch systems were made with a bicarbonate solution, and if allowed to sit at room temperature, bacterial growth could be a problem.
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When the dialysate was cooled, it also cooled the patient's blood, so a blood warmer had to be used to warm the blood before it was returned to the patient. This was a cumbersome system. A short time later, acetate replaced the bicarbonate and the need for cold dialysate and a blood warmer was eliminated.
Chronic renal care was then an actuality. Industry was now beginning to design equipment for renal care needs. No longer would physicians be required to adapt equipment to their use. Industry saw the need and they began to develop the equipment necessary to make the procedure safer, easier, and more efficient.
Scribner had shown that patients could be treated on hemodialysis equipment safely and effectively. It became evident that the financial resources available were not adequate to meet the need. He proposed that selfcare or home care be used to control the cost of dialysis. It became obvious that the large batch systems had to be modified or the application of dialysis would have to be limited.
Scribner asked Albert Bab to help him miniaturize the dialysis system. Bab, a biomedical engineer at the University of Washington, decided to build a proportioning system (see Figure 10) that would use 34 parts of water and one large proportioning pump that was being manufactured by the Milton Roy Company, a large industrial pump manufacturer. Bab set the criterion that this system had to be a totally guarded system so that it could be used in the home for overnight, unattended dialysis. It had to proportion properly, monitor temperature, guard against blood leaks, and provide for predictable fluid removal.
The system worked so well that Milton Roy set up a manufacturing group that was dedicated to the production of hemodialysis equipment.
Other companies such as Extracorporeal, which was later purchased by Baxter Healthcare, were formed to meet the demand for these types of delivery systems in the early 1960s.
The Dow Corporation
Dow had given the University of Michigan a grant to see what medical applications there were for hollow fiber technology. The company knew that the membrane was atraumatic to blood and that oxygen could transfer through it. Richard Stewart, MD, was given the responsibility to work with this material and determine if it had a medical application.
Stewart saw that the hollow fiber was not a good design for use as an oxygenator membrane because the internal diameter of the membrane was too small to allow for the flow rates requited. Stewart suggested that the hollow fiber membrane might be just right for use as an artificial kidney. With the help of Dow, he constructed a number of these devices (see Figure II) and he was able to prove that this design was superior to the previous coil and fiat plate design. Dow set up a subsidiary that began to market hollow fiber dialyzers, and 15 years later, the capillary flow artificial kidney has become the standard of the industry.
The Beginning of Peritoneal Dialysis
In the late 1950s, not all physicians were satisfied with hemodialysis. They looked for a system that did not require the complicated hemodialysis equipment. Peritoneal dialysis had been described in the past, but the results were not encouraging due to a high infection rate. Morton Maxwell, MD, from California, was one who was uncomfortable with hemodialysis. He asked Joseph Miller and others to help him put together a peritoneal system that could be used at bedside. He approached a local manufacturer of IV solutions, Don Baxter, to see if the company would make the solutions and sets required for peritoneal dialysis. There was not a lot of interest in this project because peritoneal dialysis was not popular due to the infectious complications involved. Maxwell convinced Don Baxter, Inc. to produce the system and Maxwell was able to publish on his results very positively in 1959 (Maxwell, Rockney, & Kleenan, 1959). Others would begin to look at peritoneal dialysis as an alternative to hemodialysis.
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Scribner, Boen, and Tenckhoff of Seattle, and Palmer of Vancouver, British Columbia, began to look for an automated peritoneal dialysis system that could be used in the home as an alternative to hemodialysis. They turned to Quinton Instruments to provide the permanent catheters for peritoneal dialysis. Physio Control, also from Seattle, and others would provide the peritoneal dialysis proportioning equipment for the home.
The Gottscho Packaging Company in New Jersey would help Norman Lasker, MD, to manufacture the first peritoneal dialysis cycler that was designed to be a simple, automated method of performing peritoneal dialysis. Ira Gottscho, the owner, was motivated to help because his daughter had died of renal failure.
The Impact of Medicare Reimbursement in 1973
Prior to 1973, there was a very strict rationing of dialysis care by patient selection committees. Dialysis care was not available for patients who did not have the ability to pay for it. With the introduction of federal funding through Medicare for coverage of dialysis, dialysis became available to all patients regardless of age or preexisting disease. The number of treatment centers expanded dramatically. Industry focused on the needs of the dialysis community by refining the equipment required and by making the disposables more efficient.
Nurses in Industry
It is important to note that the very first dialysis program at the Peter Bent Brigham in 1948 would not have been possible without the dedication of the first dialysis nurse, Barbara Coleman, RN. She was the first to publish the treatment protocol for patients on the Olsen Rotating Dram Kidney (Coleman & Merrill, 1952). Most of the initial hemodialysis programs throughout the world had their staff trained by Barbara Coleman. She was a key person in the early development and use of the artificial kidney.
As companies began to address the needs of the dialysis community, it became apparent that clinical experience in hemodialysis was necessary in assisting the dialysis community in achieving their objectives. Today, we see the nurse with specialization in nephrology in every phase of industry. Nephrology nurses are selling, training, managing product lines, managing marketing programs, conducting clinical trials, and performing other activities critical to the development of renal care. Industry will continue to rely on the expertise of the renal nurses because they are critical in the development of this medical specialty.
The Move to Self Care
Prior to 1973, self-care dialysis was primarily centered on home hemodialysis. This was a very cost-intensive procedure because it required so much equipment and extensive training of the patient and helper. There were a few programs that used automated peritoneal equipment for home dialysis, but these were few due to the complicated equipment and the time required. The number of home patients dropped dramatically after the introduction of the 1973 Medicare Legislation.
In 1975, Popovich and Moncrief from Austin, Texas, demonstrated that a patient could manage self care using the "Equilibrated Peritoneal Dialysis," which was later named CAPD (continuous ambulatory peritoneal dialysis).
They approached several companies with their idea. At that time, Baxter was in the process of converting its IV products from glass to plastic containers. The Baxter Canadian market was further along in this transition. They were manufacturing peritoneal solutions in 2 liter collapsible containers that were not air dependent. Dimitrios Oreopoulos, MD, at the Toronto Western Hospital, had suggested that the peritonitis rates were markedly reduced using the closed system.
Baxter began to petition the FDA to license the manufacture of the 2 liter collapsible container, and the license was granted in 1979. The company then developed a CAPD exchange system (see Figure 12). From that date on, Baxter and others began to focus their attention on developing systems that were more user-friendly and addressed the issues of increased efficiency and reduced complications.
Self-care peritoneal dialysis has now become the fastest growing segment of the dialysis industry because it allows the treatment to complement and not interfere with the lifestyle of the patient. Dialysis is just one of the many home care procedures that has been developed by industry to help patients live a more normal life by being responsible for their own care.
What Is the Future?
Industry is in the process of developing treatments for the anemia associated with renal failure as well as focusing on better methods of access. The equipment and disposables will continue to be improved so that the procedure will be easier, safer, and more efficient.
There are special efforts on the part of industry and medicine to refine the approach to adequate nutrition. It is felt that this area must be addressed as a service and as a medical necessity.
In conclusion, industry has taken the dialysis experiment out of the laboratory and made it into a practical, cost effective procedure. It has standardized the treatment by producing and making available training material on dialysis on a broad basis. Trained nursing and sales personnel are representing industry so that treatment expertise is always available to the practitioner.
Industry has formed an alliance with the medical community to insure that the patient who needs renal care will receive the most efficient and cost effective care available. The patient's needs will always come first.
Note: This article is reprinted in its entirety from ANNA Journal, 1989, Vol. 16, No. 3, pp. 277-220, 222-226.
Abel, J., Turner, B.B., & Reentry, L. (1914). Removal of diffusable substances from the circulating blood of living animals by dialysis. Journal of Pharmacology and Experimental Therapeutics, 5, 275-316, 611-613.
Coleman, B., & Merrill, J.P. (1952). The artificial kidney. American Journal of Nursing, 52(3), 327-329.
Maxwell, M.H., Rockney, RE., & Kleeman, C.R. (1959). Peritoneal dialysis: Techniques and applications. Journal of the American Medical Association, 170, 917-924.
Patrick McBride, at the time of this article's original publication, had been associated with the dialysis division of Baxter Healthcare for over 20 years in sales, clinical research, and technical education. He has written two editions of Genesis of the Artificial Kidney, and contributed a chapter in Allen Nissenson's book, Clinical Dialysis. He has also produced the film, Dialysis the Challenge, a historical collage of the development of the artificial kidney.
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|Title Annotation:||A Look Back ...; health care industry|
|Publication:||Nephrology Nursing Journal|
|Article Type:||Clinical report|
|Date:||Mar 1, 2009|
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