Tissue banking, biovigilance and the notify library.

This issue is dedicated to the contributions of Professor Glyn O. Phillips to the field of tissue banking and the advancement of science in general. The use of ionizing radiation to sterilize medical products drew the interest of the International Atomic Energy Agency (IAEA). A meeting in 1976 in Athens Greece to present work on the effects of sterilizing radiation doses upon the antigenic properties of proteins and biologic tissues was my first introduction of Professor Phillips and the role that he was to play in Tissue Banking (Friedlaender, in Phillips GO, Tallentine AN (eds) Radiation sterilization. Irradiated tissues and their potential clinical use. The North E. Wales Institute, Clwyd, p 128, 1978). The IAEA sponsored subsequent meetings in the Republic of Korea, Czechoslovakia and Rangoon, the later including a visit to the tissue bank by Professor Phillips. His advocacy resulted in multiple workshops and teaching opportunities in a variety of countries, one of which led to the establishment of the Asia Pacific Surgical Tissue Banking Association in 1989 (Phillips and Strong, in Phillips GO, Strong DM, von Versen R, Nather A (eds) Advances in tissue banking, vol 3. World Scientific, Singapore, pp 403-417, 1999).

Innovation in medicine: Ignaz the reviled and Egas the regaled.

In our current climate of rapid technological progress, it seems counterintuitive to think that modern science can learn anything of ethical value from the dark recesses of the nineteenth century or earlier. However, this happens to be quite true, with plenty of knowledge and wisdom to be gleaned by studying our scientific predecessors. Presently, our journals are flooded with original concepts and potential breakthroughs, a continuous stream of ideas pushing the frontiers of knowledge ever forward. Some ideas flourish while others flounder; but what sets the two apart? The distinguishing feature between success and failure within this context is the ability to discern the appropriate time to accept an innovation with open arms, versus when to take a more cautious approach. And the primary arbiters for whether an idea will catch on or not are the professional audience. I illustrate this concept by comparing the initial reception of two innovative ideas from Medicine's past: sterile technique, and prefrontal lobotomy. Sterile technique was first introduced by Dr. Ignaz Semmelweis and was initially ridiculed and rejected, with Semmelweis eventually dying in exile. Conversely, lobotomy was accepted and lauded and its inventor, Dr. Egas Moniz, won the Nobel Prize for his "discovery". This begs the question: why was a technique with the potential to save millions of lives initially rejected, whereas paradoxically, one that compromised and sometimes destroyed lives, accepted? Here I explore and analyze the potential reasons why, suggest how we can learn from these mistakes of the past and apply new insight to some current ethical dilemmas.

The American Neurological Association's Book "Eugenical Sterilization: A Reorientation of the Problem" Through the Lens of Contemporaneous Book Reviews.

BACKGROUND: In 1936, the American Neurological Association (ANA) published the book "Eugenical Sterilization: A Reorientation of the Problem" in response to what the first author of the book described as a positive reception to a paper presented at the ANA's 1935 annual meeting. The conclusions of the presentation were approved by the organization during the same meeting. As evidenced by the publication of several book reviews in a variety of medical journals, the book garnered some attention. METHODS: Reviews of the ANA's book were sought using PubMed, Google Scholar, and Embasa. Also, the book's title was used to search the World Wide Web. RESULTS: The search yielded four reviews, all published in 1937. The reviews make evident a positive opinion of the ANA's book's authors' recommendations including the option for "selective sterilization" of patients with conditions such as Huntington disease, Friedreich ataxia, and epilepsy. In addition, reviewers highlighted the book's authors' assessment that "the feebleminded [breed] docile, servile, useful people who do the dirty work of the race, [as] servants fulfilling a social function." CONCLUSIONS: Although the book's authors did not advocate for all-out eugenical sterilization, they did little to counter the popular opinion that patients with certain neurological diseases were a drain on society. In addition, they espoused a positive vision of the feebleminded's role as servants who can do undesirable work. This message was disseminated through book reviews.

Today's sterilizer is not your father's water heater.

Today's sterilizers are sophisticated, automatic, and computerized devices that accurately execute programmed jobs, creating uniform conditions inside pressure vessels to achieve sterilization. Specialized knowledge is necessary to ensure that the right cycle is selected; this requires an educated and competent operator.Perioperative nurses need to understand regulatory requirements for sterilizers, sterilizer design and performance validation, sterilizer cycle functions for everyday use, and everyday sterilization procedures.

"The tubercular cow must go": business, politics, and Winnipeg's milk supply, 1894-1922.

This paper analyzes the Winnipeg health department's campaign to eliminate tuberculosis in dairy herds supplying milk to the city. It examines the complexity of creating dairy policies at a time when there was no consensus about the role that Mycobacterium bovis played in the etiology of tuberculosis in humans, and when dairy producers and consumers often resisted regulations that increased their costs. The article argues that the scientific debates about the regulation of the city's milk supply enabled physicians and veterinarians to enlarge their professional practices; that the benefits and costs of the dairy policies were not equally distributed; and that Winnipeg's milk supply remained vulnerable to both deliberate and accidental contamination throughout this period.

Water disinfection: microbes versus molecules--an introduction of issues.

"Water is, apart from the air one breathes, the only nutrient which is, as a matter of necessity, consumed by every human being from the first day to the last day of his existence, and it is consumed in considerably larger quantities than any other nutritional substance."(1)

History of plasma-product safety.

The evolution of transfusion or infusion therapies for diseases requiring specific protein replacements (e.g., hemophilia A and B and severe combined immunodeficiency syndrome) was dramatic over the second half of the 20th century. Unfortunately, it was accompanied by extreme manifestations of transfusion-transmitted diseases, such as human immunodeficiency virus (HIV), hepatitis B, and hepatitis C. The milestones of both the replacement therapies and the associated diseases are discussed in this presentation, which focuses on the technologic advances that resulted in even more "pure" replacement therapies for plasma-protein diseases. From donor screening to the development of viral attenuation techniques, every facet of production for these products was impacted by the exigent push for viral safety created by HIV and hepatitis. Almost invariably, this negatively affects total product yield. At the beginning of the 21st century, success in making plasma products safe from recognized and potential pathogens has dramatically increased societal pressures to produce a zero-risk, plasma-derived protein therapy. However, past improvements and low theoretic risks for future pathogen contamination have increased product cost. This is associated with a possible decrease in the overall supply of these plasma proteins because of the reduced numbers of acceptable donors and the loss of protein from expanded attenuation technology. These impacts and the role of dynamic societal and scientific pressures on these decision processes are discussed.

[Louis Pasteur (1822-1895). A century later]. / Louis Pasteur (1822-1895). Een eeuw later.

An overview of the amazing series of successive and diverse items worked on by the chemist and physicist Pasteur starts with the asymmetry of paratartrates, switches over to the fermentations and ends in the fight against diseases of invertebrates and vertebrates, including man. It is the wonderful story of an exceptional contribution to the advancement of knowledge, which was made possible by his keen observation skill, his rigorous and innovative methods and his careful judgement. A retrospective analysis of the inner man may impair somewhat the fame of Pasteur. He was a lonely man, in need of solitude to be able to make full use of his thinking capacity, foreboding secretiveness and shrewdness , which are contradictory to his careful writing down day after day of all the details of his thinking and research in his notebooks by now available to the scientific community. He was furthermore selfish, domineering, inflexible, impulsive and inclined to engage in endless controversies. But on the contrary his motivation to accept new assignments was subordinate to their public welfare value and as a rule he endeavoured to work on the problems in the field and in association with those concerned. He was courageous when struck by a cerebral hemorrhage at middle age, so that its aftermath hardly hampered his research activities. The dimness cast on his personality is not up to his pioneer role within a general conservative climate among the medical and even scientific profession, antagonistic to innovation. Pasteur has been a founder of stereochemistry, microbiology and its applications, immunology, bacterial vaccines, pasteurisation and a promotor of prevention and hygiene. These overwhelming achievements justify to keep alive the recognition of the outstanding stature of Pasteur.

[Innovation in nineteenth century healthcare: disinfection stations]. / Una nuova istituzione igienico sanitaria nel XIX secolo: le stazioni di disinfezione.

The possibility of limiting and preventing epidemics by cleansing everything that could be touched by patients, was an intuitive thought well before microbial discoveries. In accordance with the "miasmas theory", morbid substances were emanated from the bodies of the patients. A step forward took place in the 19th century with Pasteur and Koch's discoveries and progress in chemical disinfectants. The law was slow to adapt: in Italy only in 1888 was a Code drawn up to establish some "Disinfection Stations", places for the sterilisation of infectious material from patients' homes. Later, a similar home service was started for everything that was not transportable. Thus, in the case of cholera, smallpox, scarlet fever, diphtheria, typhus, tuberculosis, etc. it became possible to sterilise everything with which patients came into contact.

From Tomato King to World Food Prize laureate.

This autobiographical article describes my early years, education, and career at Purdue University. Helping form and expand the Department of Food Science at Purdue was exciting and gratifying, and working with students in the classroom and on research projects was rewarding and kept me feeling young. My research on bulk aseptic processing allowed me to help solve problems relevant to the tomato industry, but I learned later that it had much broader relevance. I certainly never expected the impact and visibility of the work to result in my being awarded the World Food Prize. Being the first food scientist to win this award has enabled me to focus increased attention on the need to reduce food losses.

History of sterile compounding in U.S. hospitals: learning from the tragic lessons of the past.

PURPOSE: The evolution of sterile compounding in the context of hospital patient care, the evolution of related technology, past incidents of morbidity and mortality associated with preparations compounded in various settings, and efforts over the years to improve compounding practices are reviewed. SUMMARY: Tightened United States Pharmacopeial Convention standards (since 2004) for sterile compounding made it difficult for hospitals to achieve all of the sterile compounding necessary for patient care. Shortages of manufactured injections added to the need for compounding. Non-hospital-based compounding pharmacies increased sterile compounding to meet the needs. Gaps in federal and state laws and regulations about compounding pharmacies led to deficiencies in their regulation. Lapses in sterility led to injuries and deaths. Perspectives offered include potential actions, including changes in practitioner education, better surveillance of sterile compounding, regulatory reforms, reexamination of the causes of drug shortages, and the development of new technologies. CONCLUSION: Over the years, there have been numerous exhortations for voluntary better performance in sterile compounding. In addition, professional leadership has been vigorous and extensive in the form of guidance, publications, education, enforceable standards, and development of various associations and organizations dealing with safe compounding practices. Yet problems continue to occur. We must engage in diligent learning from the injuries and tragedies that have occurred. Assuming that we are already doing all we can to avoid problems would be an abdication of the professional mission of pharmacists. It would be wrong thinking to assume that the recent problems in large-scale compounding pharmacies are the only problems that warrant attention. It is time for a systematic assessment of the nature and the dimensions of the problems in every type of setting where sterile compounding occurs. It also is time for some innovative thinking about ensuring safety in sterile compounding.