Conformidades e não conformidades das variáveis ambientais em um Centro de Material e Esterilização / Compliance and noncompliance of environmental variables in a Sterile Processing Department

Objetivo: Verificar as conformidades e não conformidades à legislação sanitária das variáveis ambientais em um Centro de Material e Esterilização. Método: Trata-se de um estudo observacional analítico, realizado no Centro de Material e Esterilização de um hospital regional do interior do Piauí. Os dados foram coletados por meio de um checklist em três observações e organizados em tabela com apresentação das médias simples. Resultados: Verificou-se que a média extraída das três observações para os parâmetros de temperatura, ruído, umidade e luminosidade foram: área de recepção e limpeza ­ 33°C; 58,9 dB; 36,2% e 62 lux; área de empacotamento e esterilização ­ 33,3°C; 60,8 dB; 35,5% e 57,4 lux; e área de armazenamento e distribuição ­ 34,2°C; 57,8 dB; 34,3% e 53,1 lux. Conclusão: Há inadequações entre os valores obtidos e as recomendações da legislação sanitária, o que pode refletir em prejuízos na produção bem como em consequências físicas, mentais e psicológicas ao trabalhador

[Handling and reprocessing of semicritical medical devices in the ENT - a prospective study]. / Umgang und Aufbereitung semikritischer Medizinprodukte in der HNO ­ eine prospektive Studie.

Numerous laws, guidelines and recommendations govern the handling and reprocessing of semi-critical medical devices in the field of ENT. Although mechanically reprocessing is characterized as a preferential, manual reprocessing is still conducted in most ENT clinics and medical practices for reasons of cost and practicability. In the presented study, we developed an optimized hygienic concept for reprocessing of medical products in the field of ENT.A demand analysis of rigid endoscopes and of ENT equipment was carried out based on hypothesis that only mechanical reprocessing was performed for the entire instrumentation. Additionally, patient-free activities like preparing instrumentation for examination were investigated. As a result, we could demonstrate that such patient-free activities represent a considerable time factor and as a consequence a cost factor in daily patient care. Necessary investments for only mechanical reprocessing of instrumentation including rigid endoscopes are considerably high, since number of endoscopes have to be kept very high.

Declining rates of sterilization procedures in Western Australian women from 1990 to 2008: the relationship with age, hospital type, and government policy changes.

OBJECTIVE: To describe trends in age-specific incidence rates of female sterilization (FS) procedures in Western Australia and to evaluate the effects of the introduction of government-subsidized contraceptive methods and the implementation of the Australian government's baby bonus policy on FS rates. DESIGN: Population-based retrospective descriptive study. SETTING: Not applicable. PATIENT(S): All women ages 15-49 undergoing an FS procedure during the period January 1, 1990, to December 31, 2008 (n = 47,360 procedures). INTERVENTION(S): Records from statutory statewide data collections of hospitals separations and births were extracted and linked. MAIN OUTCOME MEASURE(S): Trends in FS procedures and the influence on these trends of the introduction of government policies: subsidization of long-acting reversible contraceptives (Implanon and Mirena) and the Australian baby bonus initiative. RESULT(S): The annual incidence rate of FS procedures declined from 756.9 per 100,000 women in 1990 to 155.2 per 100,000 women in 2008. Compared with the period 1990-1994, women ages 30-39 years were 47% less likely (rate ratio [RR] = 0.53; 95% confidence interval [CI], 0.39-0.72) to undergo sterilization during the period 2005-2008. Adjusting for overall trend, there were significant decreases in FS rates after government subsidization of Implanon (RR = 0.89; 95% CI, 0.82-0.97) and Mirena (RR = 0.81; 95% CI, 0.73-0.91) and the introduction of the baby bonus (RR = 0.70; 95% CI, 0.61-0.81). CONCLUSION(S): Rates of female sterilization procedures in Western Australia have declined substantially across all age groups in the last two decades. Women's decisions to undergo sterilization procedures may be influenced by government interventions that increase access to long-term reversible contraceptives or encourage childbirth.

Risk for hepatitis B and C virus transmission in nail salons and barbershops and state regulatory requirements to prevent such transmission in the United States.

CONTEXT: The potential for hepatitis B and C virus (HBV/HCV) transmission in nail salons and barbershops has been reported, but a systematic review has not been conducted. These businesses are regulated by state cosmetology or barbering boards, but adequacy of sanitary requirements has not been evaluated. OBJECTIVES: To conduct literature review to assess risk for HBV/HCV transmission in nail salons and barbershops and to evaluate sanitary requirements in HBV/HCV prevention in these businesses in 50 states and District of Columbia. DESIGN: Several search engines were used for literature search. Studies that quantified risks associated with manicuring, pedicuring, or barbering were included. State requirements for disinfection and sterilization were reviewed and evaluated. MAIN OUTCOME MEASURE: For literature review, odds ratios, 95% confidence intervals, and confounding adjustment were extracted and evaluated. For regulation review, requirements for disinfection or sterilization for multiuse items in nail salons and barbershops were assessed according to the US federal guidelines. RESULTS: Forty-six studies were identified and 36 were included in this study. Overall, the results were not consistent on risk for HBV/HCV transmission in nail salons and barbershops. For sanitary requirements, disinfection with an Environmental Protection Agency-registered disinfectant is required in 39 states for nail salons and in 26 states for barbershops. Sterilization was described in 15 states for nail salons and in 11 states for barbershops, but the majority of these states listed it as an optional approach. Sanitary requirements are consistent in states where 1 board regulates both businesses but are substantially discrepant in states with separate boards. CONCLUSIONS: Current literature cannot confirm or exclude the risk for HBV/HCV transmission in nail salons and barbershops. Existing sanitary requirements are adequate in the majority of states, but compliance is needed to prevent HBV/HCV transmission in these businesses.

Rapid development of tissue bank achieved by International Atomic Energy Agency (IAEA) Tissue Banking Programme in China.

Before 1986, the development of tissue banking in China has been slow and relatively uncoordinated. Under the support of International Atomic Energy Agency (IAEA), Tissue Banking in China experienced rapid development. In this period, China Institute for Radiation Protection tissue bank mastered systematic and modern tissue banking technique by IAEA training course and gradually developed the first regional tissue bank (Shanxi Provincial Tissue Bank, SPTB) to provide tissue allograft. Benefit from training course, SPTB promoted the development of tissue transplantation by ways of training, brochure, advertisement and meeting. Tissue allograft transplantation acquired recognition from clinic and supervision and administration from government. Quality system gradually is developing and perfecting. Tissue allograft transplantation and tissue bank are developing rapidly and healthy.

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.

When is the sterilisation of an intellectually disabled child "therapeutic"? A practical analysis of the legal requirement to seek court authorisation.

It is an established legal principle that certain sterilisation procedures fall outside parental power to consent to medical treatment and thus require court authorisation prior to their performance. The practical assessment of whether court authorisation is required has traditionally focused on determining whether the procedure is one which is "therapeutic". However, the development of the legal meaning of a "therapeutic sterilisation" through judicial interpretation may have resulted in a divergence in the legal meaning of the term and its practical application. Cases involving sterilisation in the context of gender dysphoria have also raised some conceptual challenges to the previously utilised "therapeutic"/"non-therapeutic" distinction. This article advocates for the terminology "special medical procedure" to replace the words "therapeutic" and "non-therapeutic" and reintroduces the "but for" test as a potential practical tool to assist medical practitioners to negotiate this area of law successfully.

Clinical solid waste management practices and its impact on human health and environment--A review.

The management of clinical solid waste (CSW) continues to be a major challenge, particularly, in most healthcare facilities of the developing world. Poor conduct and inappropriate disposal methods exercised during handling and disposal of CSW is increasing significant health hazards and environmental pollution due to the infectious nature of the waste. This article summarises a literature review into existing CSW management practices in the healthcare centers. The information gathered in this paper has been derived from the desk study of open literature survey. Numerous researches have been conducted on the management of CSW. Although, significant steps have been taken on matters related to safe handling and disposal of the clinical waste, but improper management practice is evident from the point of initial collection to the final disposal. In most cases, the main reasons of the mismanagement of CSW are the lack of appropriate legislation, lack of specialized clinical staffs, lack of awareness and effective control. Furthermore, most of the healthcare centers of the developing world have faced financial difficulties and therefore looking for cost effective disposal methods of clinical waste. This paper emphasizes to continue the recycle-reuse program of CSW materials after sterilization by using supercritical fluid carbon dioxide (SF-CO2) sterilization technology at the point of initial collection. Emphasis is on the priority to inactivate the infectious micro-organisms in CSW. In that case, waste would not pose any threat to healthcare workers. The recycling-reuse program would be carried out successfully with the non-specialized clinical staffs. Therefore, the adoption of SF-CO2 sterilization technology in management of clinical solid waste can reduce exposure to infectious waste, decrease labor, lower costs, and yield better compliance with regulatory. Thus healthcare facilities can both save money and provide a safe environment for patients, healthcare staffs and clinical staffs.

“The Hour of Eugenics” in Veracruz, Mexico: radical politics, public health,and Latin America’s only sterilization law

In 1932, the Mexican state of Veracruz passed Latin America's only eugenic sterilization law. Building on the foundational scholarship of Nancy Leys Stepan, this article critically examines Veracruz's eugenics movement, exploring how it intersected with public health, antivice campaigns, and radical agrarian and labor politics. I pay particular attention to Governor Adalberto Tejeda, who, during his second term in office (1928 – 1932) incorporated a zealous version of Latin eugenics into state laws and policies. This article suggests that Veracruz's experiment with eugenics, especially the state's sterilization statute, was intimately connected to concerns about prostitution, sexual health, and working-class vigor. This article highlights an unexplored dimension of society and medicine in Latin America and raises questions about the orientation and limits of preventive eugenics in Mexico, and about the homologies among eugenics movements in the Americas and across the globe in the twentieth century. (AU)

Sterile products: advances and challenges in formulation, manufacturing and regulatory aspects--a regulatory review perspective.

For several decades, the FDA has undertaken many initiatives to improve the quality and safety of sterile drug products. In recent years, efforts have also been undertaken to accelerate the rate for application approval by adding earlier involvement of microbiology reviewers in drug development. Product and manufacturing process development, as well as safe use and product design, are among the elements of enhanced technical involvement. An overview of the product quality microbiology aspects for sterile drugs is provided.

Licensing a new industrial irradiator.

After nearly three decades of medical product sterilization, 3M launched a major new project to build and license an irradiator facility. 3M Corporate Health Physics was responsible for the licensing aspect of this project. The licensing process consisted of six amendments, over 30 submissions to the U.S. Nuclear Regulatory Commission (U.S. NRC) and four U.S. NRC site visits. It took approximately 22 months to complete. The six license amendments are reviewed and several of the submissions are discussed. These include 3M's response to the U.S. NRC's interest in the shielding calculations used for the bioshield, the development of a protocol of radiation safety system test methods, and an analysis to show that a dropped cask during loading operations would not fall on sealed sources. A number of lessons were learned during the course of licensing the new irradiator. Among these were the importance of understanding the U.S. NRC license reviewer's perspective, the need to thoroughly review the irradiator manufacturer's licensing package during project negotiations, the benefits of leaving the Health Physics Office and meeting with the non-health physicists involved in the project, and the necessity of maintaining the solid relationships that already existed with the site Radiation Safety Officer and Sterilization Engineer.