DONOR PLASMAPHERESIS A CONTREVERSIAL ISSUE IN BLOOD COLLECTION
Most people who have written about the early origin of the H1V and hepatitis blood scandals of the early-eighties have not taken into consideration the role of blood collection technology.
The key but forgetten element is donor plasmapheresis. These techniques originated primarily for therapeutic applications in the late-sixties. They are high risk procedures and met with severe complications from the outset. However, their applications were justified because of the severity of the diseases they addressed (including leukemia). Early participants in this technology included a precursor to Baxter, then known as Travenol/Aminco.
Early commercial devices for plasmapheresis included crude on-line blood separators derived from the Sorvall patents on milk separators. These machines were widely sold hospitals. Their primary problems were the rotor and and the rotary fluid seal assemblies which were not disposable. These expensive and complex parts would shed abraded debris. They required manual disassembly and elaborate cleaning procedures followed by reassembly. Exhaustive sterelization was needed between each use. These processes required skilled technitians and much time. This was not technologically feasible under hurried clinical conditions.
Several of these machines are still in use, albeit for speciallized therapeutic applications, later variations of commercially made plasma separation devices had on-line versions and these found widespread usage in the blood banking industries. They were encoutered extensively in the San Francisco and Oakland blood collection centers, even in the early- eighties. They had major problems of sterility and solid particulates contamination control.
Valuable "frequent donors" were often pressured to join plasmapheresis programs. The programs were promoted as state-of-the-art technologies of great merit without special risks that allowed blood donations as frequently as several times at month. Contractors with facilities in penal institution collections programs used it almost universally up to the late-nineties. The Red Cross, bayer, Connaught and Cutter also depended on these programs for collection of donor blood streamed into commercial blood fractionation plants, as did the association of the independent American Blood Bank and the other contractor-type blood collection agencies such as Cryosan/Continental Pharma.
Continental Phama (CCP) later emerged as a major factor in contaminated blood supplies. It affected mostly non-U.S. bulk blood product purchasers, specifically Canadian blood agencies. CCP had contracts for blood collection from inmates at Arkansas penal institutions and sold bulk blood products to American processors for resale abroad. CCP had poor control over the collection process and may have infringed on basic requirements on the use of plasmapherisis equipment. In the mid-nineties, CCP records were investigated and the agency figured prominently in a Canadian blood coandal. Their blood-derived products were identified as high infection risk material, specifically with HIV and hepatitis.
CCP and other similar agencies depended strongly or rapid low cost blood collection techniques which made use the same donors. Plasmapheresis was an essential element in the economic viability of the program.
During high volume blood/plasma collection via plasmapheresis, there is simultaneous separation of the principal blood componement. The unwanted red cells are returned to the donor either as a separate step at the session (called manual plasmapheresis) or as an integral part of the collection procedure (on-line plasma separation). The donor may remain connected to a separation device for several hours as blood is processed and the red cells are reinfused through a separate line or through a single but concentric needle/cannulae system.
Plasmaperesis requires drugs to facilitate separation of minority components. Typically, steroids like SoluMedrol are given to facilitate aglomeration of certain fractions. Incidental to processing, the incoming blood must be mixed with anticoagulants. The most common preparation is the citrate buffer. This solution dilutes the blood to facilitate the separation process and the coagulant is then reinfused into the user. Alternate anticoagulants such as heparin are considered too costly and are employed only in certain types of therapeutic plasmapheresis. These various additives are belleved to be compatible and necessery for situations where more frequent donations are wanted and where the selected blood fraction is to be optimized (increased yield or boosted plasmapheresis).
These techniques also reduce the overall cost of processing the donor blood, a factor of particular significance in commercial blood collection. In spite of widespread usage amongst healthy and voluntary donor populations, many of whom were individuals with rare blood types, the technology was not well mastered. Complications were not resolved leading to disengagement in the eighties of several firms from the field.
The techniques were then and are still controversial. The community fluent with the blood industry believes that misuse of this technology and the indiscriminate application of poorly controlled plasmapheresis systems, mishandled by improperly trained staff and unethical practices by some of the collection agencies contributed dramatically to the spread of blood-borne diseases in the eighties, in particular non-A and non-B hepatitis. Other problems unrelated to infection but derived from solid and fluid impurities entrained from the equipment which terminated in the donor remain unaddressed of this day.