RESUMEN
Iatrogenic transmission of prions, the infectious agents of fatal Creutzfeldt-Jakob disease, through inefficiently decontaminated medical instruments remains a critical issue. Harsh chemical treatments are effective, but not suited for routine reprocessing of reusable surgical instruments in medical cleaning and disinfection processes due to material incompatibilities. The identification of mild detergents with activity against prions is therefore of high interest but laborious due to the low throughput of traditional assays measuring prion infectivity. Here, we report the establishment of TESSA (sTainlESs steel-bead Seed Amplification assay), a modified real-time quaking induced cyclic amplification (RT-QuIC) assay that explores the propagation activity of prions with stainless steel beads. TESSA was applied for the screening of about 70 different commercially available and novel formulations and conditions for their prion inactivation efficacy. One hypochlorite-based formulation, two commercially available alkaline formulations and a manual alkaline pre-cleaner were found to be highly effective in inactivating prions under conditions simulating automated washer-disinfector cleaning processes. The efficacy of these formulations was confirmed in vivo in a murine prion infectivity bioassay, yielding a reduction of the prion titer for bead surface adsorbed prions below detectability. Our data suggest that TESSA represents an effective method for a rapid screening of prion-inactivating detergents, and that alkaline and oxidative formulations are promising in reducing the risk of potential iatrogenic prion transmission through insufficiently decontaminated instrument surfaces.
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Priones , Acero Inoxidable , Instrumentos Quirúrgicos , Animales , Ratones , Acero Inoxidable/química , Descontaminación/métodos , Síndrome de Creutzfeldt-Jakob/transmisión , Síndrome de Creutzfeldt-Jakob/prevención & control , Desinfección/métodos , Detergentes/química , Detergentes/farmacología , Humanos , Desinfectantes/farmacología , Oxidación-ReducciónAsunto(s)
Síndrome de Creutzfeldt-Jakob , Equipo Reutilizado , Laringoscopios , Laringoscopios/efectos adversos , Laringoscopios/economía , Laringoscopios/microbiología , Laringoscopios/normas , Síndrome de Creutzfeldt-Jakob/prevención & control , Síndrome de Creutzfeldt-Jakob/transmisión , Laringoscopía/instrumentación , Equipos Desechables/economía , Equipos Desechables/microbiología , Equipos Desechables/tendencias , Equipo Reutilizado/normas , HumanosRESUMEN
BACKGROUND: Recent case studies and media outlets have hypothesised an effect of SARS-CoV-2 infection and immunisation on the development or progression of neurodegenerative diseases such as Alzheimer's disease or sporadic Creutzfeldt-Jakob disease (sCJD). OBJECTIVES: This study aims to identify potential associations of SARS-CoV-2 infections and SARS-CoV-2 immunisation with sCJD incidence, disease duration, and age of onset. METHOD: We used data from a prospective sCJD surveillance study in Germany (2016-2022) and publicly available datasets of SARS-CoV-2 cases and vaccination numbers in Germany for the years 2020-2022. Associations of SARS-CoV-2 incidence and immunisation rates with sCJD incidence were assessed by comparing quarterly and annual cumulative sCJD incidences in the periods before (2016-2019) and during the pandemic (2020-2022). RESULTS: We could not identify any time-related effect of SARS-CoV-2 incidence or immunisation rate on the sCJD incidence. Moreover, we did not find any sCJD incidence alterations before and during the SARS-CoV-2 pandemic on a federal or state level. The overall sCJD incidence was within expected ranges in the years 2020-2022. There were no changes in age of onset and clinical disease duration in these years. CONCLUSIONS: We found no evidence supporting a short-term effect of the pandemic on sCJD incidence. However, considering the extended pre-clinical phase of sCJD, continued surveillance is needed to identify potential future incidence alterations.
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COVID-19 , Síndrome de Creutzfeldt-Jakob , Humanos , Síndrome de Creutzfeldt-Jakob/epidemiología , Síndrome de Creutzfeldt-Jakob/prevención & control , Incidencia , SARS-CoV-2 , Estudios Prospectivos , COVID-19/epidemiología , COVID-19/prevención & control , Inmunización , VacunaciónRESUMEN
BACKGROUND: Prions are renowned for their distinct resistance to chemical or physical inactivation, including steam sterilization. Impaired efficacy of inactivation poses a risk to patients for iatrogenic transmission of Creutzfeldt-Jakob disease (CJD) via contaminated surgical instruments. AIMS: Most established prion inactivation methods were validated against scrapie agents, although those were found to be generally less thermostable than human prions. Thus, knowledge gaps regarding steam-sterilization kinetics of CJD prions should be filled and current guidelines reviewed accordingly. METHODS: Prion inactivation through widely recommended steam sterilization at 134°C was assessed for several holding times by analysing the residual prion seeding activity using protein misfolding cyclic amplification (PMCA). FINDINGS: Scrapie 263K was found to be the least thermoresistant prion strain showing no seeding activity after 1.5 min at 134°C, while variant CJD was the most stable one demonstrating some seeding activity even after 18 min of steam sterilization. Sporadic CJD subtype VV2 exhibited residual seeding activity after 3 min, but no detectable activity after 5 min at 134°C. CONCLUSION: Validated steam sterilization for 5 min at 134°C as previously recommended for the routine reprocessing of surgical instruments in contact with high-risk tissues is able to substantially reduce the seeding activity of CJD agents, provided that no fixating chemical disinfection has been performed prior to sterilization and that thorough cleaning has reduced the protein load on the surface to less than 100 µg per instrument.
Asunto(s)
Síndrome de Creutzfeldt-Jakob , Desinfección , Priones , Vapor , Humanos , Síndrome de Creutzfeldt-Jakob/prevención & control , Desinfección/métodos , Scrapie/metabolismoRESUMEN
In Japan, 156 cases of dura mater-transplanted Creutzfeldt-Jakob disease(dCJD)with a history of Lyodura transplantation have been confirmed until February 2022, with only a few new cases still being identified. The history of Lyodura transplantation is one involving a neurosurgical procedure. The cumulative global number of cases of bovine spongiform encephalopathy-related variant CJD(BSE-related vCJD), which has shaken societies around the world, is 232 as of 2019. Thus, the impact of dCJD on the society in Japan needs no explanation. Thanks to the world's concerted efforts in research and countermeasures, medically induced prion diseases are finally becoming a thing of the past. However, due to the extremely long incubation period of CJD and the difficulty of tracing the source of infection, immediate action in the event of an outbreak is not possible, and efforts must focus on preventing disease outbreaks. Independent of this, approximately 200 cases of solitary and hereditary prion diseases occur annually in Japan. If neurosurgery must be performed on such patients, secondary transmission of prion disease by neurosurgical instruments must be prevented. Therefore, sterilization methods for neurosurgical instruments are critical, and various measures including sterilization methods have been determined and published by a research group designated by the Japanese Ministry of Health, Labour and Welfare. The sterilization of neurosurgical instruments should comply with the latest guidelines that are published by this study group.
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Síndrome de Creutzfeldt-Jakob , Neurocirugia , Enfermedades por Prión , Priones , Animales , Bovinos , Colágeno , Síndrome de Creutzfeldt-Jakob/prevención & control , Síndrome de Creutzfeldt-Jakob/cirugía , Humanos , Procedimientos Neuroquirúrgicos , Enfermedades por Prión/epidemiología , Enfermedades por Prión/prevención & control , Enfermedades por Prión/cirugíaRESUMEN
Following recognition that blood, blood components, tissues and organs donated by infected donors could transmit infectious prions causing variant Creutzfeldt-Jakob Disease (vCJD), several risk reduction measures were introduced in the UK. The Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) established a working group to review the measures in place. Factors considered included: ethical issues around the current provisions and potential changes; operational issues for blood establishments and hospitals; a review from the Advisory Committee on Dangerous Pathogens (ACDP) showing the downward trend in the estimated number of future cases of vCJD; and cost-effectiveness. The working group recommended that the current vCJD risk reduction measures for individuals born after 1995 or with thrombotic thrombocytopenic purpura (TTP) could be withdrawn. After consultation with stakeholders, SaBTO accepted these proposals which allow more equal provision of components, less operational complexity and risk, and more resources to be deployed elsewhere in the NHS. The potential saving on plasma will be £500 m and moving to using pooled platelets in additive solution for all recipients will bring potential savings of £280 m over the next 50 to 60 years. There could be small number of additional clinical cases of vCJD: 1-2 (<1-14; 95% CI) from plasma and 3-4 (<1 to 45; 95% CI) from platelets. Local and national guidelines will still be applied for managing individual conditions. UK Ministers for Health accepted SaBTO's recommendations on 9 Sept 2019 and implementation began immediately. This paper describes the review and rationale leading to these recommendations.
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Eliminación de Componentes Sanguíneos , Síndrome de Creutzfeldt-Jakob , Reacción a la Transfusión , Plaquetas , Síndrome de Creutzfeldt-Jakob/prevención & control , Humanos , Conducta de Reducción del RiesgoRESUMEN
Advanced age is the main risk factor for the manifestation of late onset neurodegenerative diseases. Metformin, an anti-diabetic drug, was shown to extend longevity, and to ameliorate the activity of recognized aging hallmarks. Here, we compared the clinical, pathologic and biochemical effects of Metformin to those of Nano-PSO (Granagard), a brain targeted anti-oxidant shown by us to delay disease advance in transgenic mice mimicking for genetic Creutzfeldt Jacob disease (CJD) linked to the E200KPrP mutation. We demonstrate that both Metformin and Nano-PSO reduced aging hallmarks activities such as activated AMPK, the main energy sensor of cells as well as Nrf2 and COX IV1, regulators of oxidation, and mitochondrial activity. Both compounds reduced inflammation and increased stem cells production, however did not decrease PrP accumulation. As opposed to Nano-PSO, Metformin neither delayed clinical disease advance in these mice nor reduced the accumulation of sulfated glycosaminoglycans, a pathologic feature of prion disease. We conclude that elevation of anti-aging markers may not be sufficient to delay the fatal advance of genetic CJD.
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Síndrome de Creutzfeldt-Jakob/genética , Síndrome de Creutzfeldt-Jakob/prevención & control , Metformina/farmacología , Metformina/uso terapéutico , Aceites de Plantas/farmacología , Aceites de Plantas/uso terapéutico , Adenilato Quinasa/metabolismo , Animales , Antioxidantes , Modelos Animales de Enfermedad , Complejo IV de Transporte de Electrones/metabolismo , Ratones , Ratones Transgénicos , Mutación , Factor 2 Relacionado con NF-E2/metabolismo , Proteínas PrPSc/genética , Proteínas PrPSc/metabolismoRESUMEN
Creutzfeldt-Jakob disease (CJD) is a transmissible spongiform encephalopathy whose initial description is associated with two German authors, Alfons Maria Jakob and Hans Gerhard Creutzfeldt. As polemic as the issue about the Creutzfeldt's merit in the first description of the disease, is his history during the Third Reich. Some evidence pointed to the idea that he was essentially against the Nazi ideology, though some did not. He was an official member of the SS, but his own wife was convicted by a Nazi court. Some authors have argued that Creutzfeldt helped save many patients during Aktion T4 operation, but, in fact, he could have done more. Even during the post-war period, he sent a letter to authorities reporting the name of a Nazi physician who worked as a medical reviewer at the euthanasia court, but he did not proceed any further when his letter initially failed to start an investigation.
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Síndrome de Creutzfeldt-Jakob , Eutanasia , Síndrome de Creutzfeldt-Jakob/prevención & control , Alemania , Desinfección de las Manos , Historia del Siglo XX , Humanos , Masculino , Nacionalsocialismo , PolíticasRESUMEN
BACKGROUND: Sensitive, direct protein-detection methods are now recommended for the inspection of reprocessed reusable surgical instruments in England to reduce the risk of prion transmission. AIM: To implement an established, highly sensitive method to quantify proteinaceous residues on reprocessed instruments in a Sterile Services Department (SSD) and evaluate its potential impact on service provision. METHODS: We introduced highly sensitive epifluorescence (EDIC/EF) microscopy in a large SSD. Over three years, we periodically tested two models of washer disinfector using stainless-steel tokens spiked with mouse brain homogenate or Browne test soil for comparison. We also obtained data and feedback from staff who had been using EDIC/EF to examine almost 3000 reprocessed instruments. FINDINGS: All reprocessed test surfaces harboured residual contamination (up to 258.4 ng from 1-µg spikes). Proximity between surfaces affected decontamination efficacy and allowed cross-contamination. Up to 50 ng de novo proteinaceous contamination was deposited on control surfaces after a single automated washer disinfector (AWD) cycle. The test soil behaved differently than real tissue contamination. SSD staff observed proteinaceous residues on most reprocessed instruments using EDIC/EF, which can detect far smaller amounts than the currently accepted national threshold of 5 µg per side. CONCLUSIONS: Implementing recent national guidelines to address the prions concern proved an eye-opener. Microscopic levels of proteins remain on many reprocessed instruments. The impact most of these residues, potentially including prions, may have on subsequent patients after sterilization remains debatable. Improving surveillance capability in SSDs can support decision making and raise the standards of surgical instruments reprocessing.
Asunto(s)
Síndrome de Creutzfeldt-Jakob , Descontaminación , Contaminación de Equipos , Instrumentos Quirúrgicos , Animales , Síndrome de Creutzfeldt-Jakob/prevención & control , Descontaminación/normas , Inglaterra , Contaminación de Equipos/prevención & control , Humanos , RatonesRESUMEN
ABSTRACT Creutzfeldt-Jakob disease (CJD) is a transmissible spongiform encephalopathy whose initial description is associated with two German authors, Alfons Maria Jakob and Hans Gerhard Creutzfeldt. As polemic as the issue about the Creutzfeldt's merit in the first description of the disease, is his history during the Third Reich. Some evidence pointed to the idea that he was essentially against the Nazi ideology, though some did not. He was an official member of the SS, but his own wife was convicted by a Nazi court. Some authors have argued that Creutzfeldt helped save many patients during Aktion T4 operation, but, in fact, he could have done more. Even during the post-war period, he sent a letter to authorities reporting the name of a Nazi physician who worked as a medical reviewer at the euthanasia court, but he did not proceed any further when his letter initially failed to start an investigation.
RESUMO A doença de Creutzfeldt-Jakob (DCJ) é uma encefalopatia espongiforme transmissível, cuja descrição original está associada ao nome de dois autores alemães, Alfons Maria Jakob e Hans Gerhard Creuztfeldt. Tão polêmica quanto a questão sobre o real mérito de Creutzfeldt na primeira descrição da doença, é sua história de vida durante o Terceiro Reich. Algumas evidências apontavam para a ideia de que ele era essencialmente contra a ideologia nazista, mas outras não. Ele foi um membro oficial da SS, mas sua própria esposa foi condenada por um tribunal nazista. Alguns autores têm argumentado que Creutzfeldt ajudou a salvar muitos pacientes durante a operação Aktion T4, mas, na verdade, ele poderia ter feito muito mais. Mesmo durante o período pós-guerra, ele enviou uma carta às autoridades revelando o nome de um médico nazista que havia se empregado como revisor médico na corte sobre eutanásia, mas ele não insistiu mais quando sua carta inicialmente não desencadeou uma investigação.
Asunto(s)
Humanos , Masculino , Historia del Siglo XX , Eutanasia , Síndrome de Creutzfeldt-Jakob/prevención & control , Desinfección de las Manos , Nacionalsocialismo , Políticas , AlemaniaRESUMEN
gCJD is a fatal late-onset neurodegenerative disease linked to mutations in the PRNP gene. We have previously shown that transplantation of neural precursor cells (NPCs), or administration of a nanoformulation of pomegranate seed oil (Nano-PSO, GranaGard), into newborn asymptomatic TgMHu2ME199K mice modeling for E200K gCJD significantly delayed the advance of clinical disease. In the present study, we tested the individual and combined effects of both treatments in older and sick TgMHu2ME199K mice. We show that while transplantation of NPCs at both initial (140 days) and advance clinical states (230 days) arrested disease progression for about 30 days, after which scores rapidly climbed to those of untreated Tgs, administration of Nano-PSO to transplanted TgMHu2ME199K mice resulted in detention of disease advance for 60-80 days, followed by a slower disease progression thereafter. Pathological examinations demonstrated the combined treatment extended the survival of the transplanted NPCs, and also increased the generation of endogenous stem cells. Our results suggest that administration of Nano-PSO may increase the beneficial effects of NPCs transplantation.
Asunto(s)
Síndrome de Creutzfeldt-Jakob/terapia , Nanoestructuras/administración & dosificación , Células-Madre Neurales/trasplante , Aceites de Plantas/administración & dosificación , Granada (Fruta)/química , Animales , Síndrome de Creutzfeldt-Jakob/prevención & control , Modelos Animales de Enfermedad , Progresión de la Enfermedad , Ratones Transgénicos , Aceites de Plantas/aislamiento & purificación , Factores de TiempoRESUMEN
BACKGROUND: Creutzfeldt-Jakob disease is a fatal neurological disease caused by abnormal infectious proteins called prions. Prions that are present on surgical instruments cannot be completely deactivated; therefore, patients who are subsequently operated on using these instruments may become infected. This can result in surgically transmitted Creutzfeldt-Jakob disease. OBJECTIVE: To update literature reviews, consultation with experts and economic modelling published in 2006, and to provide the cost-effectiveness of strategies to reduce the risk of surgically transmitted Creutzfeldt-Jakob disease. METHODS: Eight systematic reviews were undertaken for clinical parameters. One review of cost-effectiveness was undertaken. Electronic databases including MEDLINE and EMBASE were searched from 2005 to 2017. Expert elicitation sessions were undertaken. An advisory committee, convened by the National Institute for Health and Care Excellence to produce guidance, provided an additional source of information. A mathematical model was updated focusing on brain and posterior eye surgery and neuroendoscopy. The model simulated both patients and instrument sets. Assuming that there were potentially 15 cases of surgically transmitted Creutzfeldt-Jakob disease between 2005 and 2018, approximate Bayesian computation was used to obtain samples from the posterior distribution of the model parameters to generate results. Heuristics were used to improve computational efficiency. The modelling conformed to the National Institute for Health and Care Excellence reference case. The strategies evaluated included neither keeping instruments moist nor prohibiting set migration; ensuring that instruments were kept moist; prohibiting instrument migration between sets; and employing single-use instruments. Threshold analyses were undertaken to establish prices at which single-use sets or completely effective decontamination solutions would be cost-effective. RESULTS: A total of 169 papers were identified for the clinical review. The evidence from published literature was not deemed sufficiently strong to take precedence over the distributions obtained from expert elicitation. Forty-eight papers were identified in the review of cost-effectiveness. The previous modelling structure was revised to add the possibility of misclassifying surgically transmitted Creutzfeldt-Jakob disease as another neurodegenerative disease, and assuming that all patients were susceptible to infection. Keeping instruments moist was estimated to reduce the risk of surgically transmitted Creutzfeldt-Jakob disease cases and associated costs. Based on probabilistic sensitivity analyses, keeping instruments moist was estimated to on average result in 2.36 (range 0-47) surgically transmitted Creutzfeldt-Jakob disease cases (across England) caused by infection occurring between 2019 and 2023. Prohibiting set migration or employing single-use instruments reduced the estimated risk of surgically transmitted Creutzfeldt-Jakob disease cases further, but at considerable cost. The estimated costs per quality-adjusted life-year gained of these strategies in addition to keeping instruments moist were in excess of £1M. It was estimated that single-use instrument sets (currently £350-500) or completely effective cleaning solutions would need to cost approximately £12 per patient to be cost-effective using a £30,000 per quality-adjusted life-year gained value. LIMITATIONS: As no direct published evidence to implicate surgery as a cause of Creutzfeldt-Jakob disease has been found since 2005, the estimations of potential cases from elicitation are still speculative. A particular source of uncertainty was in the number of potential surgically transmitted Creutzfeldt-Jakob disease cases that may have occurred between 2005 and 2018. CONCLUSIONS: Keeping instruments moist is estimated to reduce the risk of surgically transmitted Creutzfeldt-Jakob disease cases and associated costs. Further surgical management strategies can reduce the risks of surgically transmitted Creutzfeldt-Jakob disease but have considerable associated costs. STUDY REGISTRATION: This study is registered as PROSPERO CRD42017071807. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 11. See the NIHR Journals Library website for further project information.
The aims of this report were to summarise evidence relating to surgically transmitted CreutzfeldtJakob disease and to explore the value for money of strategies to reduce the chance of any future surgically transmitted CreutzfeldtJakob disease cases. Current recommendations include keeping sets of surgical instruments together for high-risk operations and using separate instruments for people born after 1996. The project involved reviewing published papers, speaking with experts and building a computer model. The literature reviews found that CreutzfeldtJakob disease occurs in around 12 per million people and that no definite cases of surgically transmitted CreutzfeldtJakob disease have been observed since the 1970s. The reviews also looked for information on the possibility of patients being infected with CreutzfeldtJakob disease after having surgery on high-risk tissues, such as the brain and the back of the eye. They found that there was a great deal of uncertainty regarding who might have CreutzfeldtJakob disease, but not yet have symptoms, as well as the risk of transmission and the ability of strategies to reduce this risk. The computer model aimed to estimate value for money of different strategies to reduce the risks of surgically transmitted CreutzfeldtJakob disease. However, the reviews found that some of the numbers needed for the model were not known, so experts were asked to estimate this information instead along with the range of possible values. This information included the effectiveness of different cleaning practices and the chances of infected tissue being transmitted between patients undergoing high-risk surgery. The model found that keeping surgical instruments moist prior to cleaning was likely to save money and reduce the chance of future surgically transmitted CreutzfeldtJakob disease cases. However, additional measures, such as using only sets of single-use instruments, ensuring that instruments were kept together in their sets or using separate instruments for those born after 1996, appeared to be poor value for money.
Asunto(s)
Análisis Costo-Beneficio , Síndrome de Creutzfeldt-Jakob , Modelos Económicos , Síndrome de Creutzfeldt-Jakob/prevención & control , Síndrome de Creutzfeldt-Jakob/transmisión , Inglaterra , Humanos , Priones/efectos adversos , Años de Vida Ajustados por Calidad de Vida , Evaluación de la Tecnología BiomédicaRESUMEN
Effective sterilization of reusable instruments contaminated by Creutzfeldtâ»Jakob disease in dental care is a crucial issue for public health. The present cross-sectional study investigated how the recommended procedures for sterilization were implemented by French dental practices in real-world settings. A sample of dental practices was selected in the French Rhône-Alpes region. Data were collected by a self-questionnaire in 2016. Sterilization procedures (n = 33) were classified into 4 groups: (1) Pre-sterilization cleaning of reusable instruments; (2) Biological verification of sterilization cycles—Monitoring steam sterilization procedures; (3) Autoclave performance and practitioner knowledge of autoclave use; (4) Monitoring and documentation of sterilization procedures—Tracking and tracing the instrumentation. Answers were provided per procedure, along with the global implementation of procedures within a group (over 80% correctly performed). Then it was verified how adherence to procedure groups varied with the size of the dental practice and the proportion of dental assistants within the team. Among the 179 questionnaires available for the analyses, adherence to the recommended procedures of sterilization noticeably varied between practices, from 20.7% to 82.6%. The median percentages of procedures correctly implemented per practice were 58.1%, 50.9%, 69.2% and 58.2%, in Groups 1, 2, 3 and 4, respectively (corresponding percentages for performing over 80% of the procedures in the group: 23.4%, 6.6%, 46.6% and 38.6%). Dental practices ≥ 3 dental units performed significantly better (>80%) procedures of Groups 2 and 4 (p = 0.01 and p = 0.002, respectively), while no other significant associations emerged. As a rule, practices complied poorly with the recommended procedures, despite partially improved results in bigger practices. Specific training regarding sterilization procedures and a better understanding of the reasons leading to their non-compliance are needed.
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Síndrome de Creutzfeldt-Jakob/prevención & control , Control de Infección Dental/métodos , Esterilización/métodos , Estudios Transversales , Francia , Humanos , Enfermedad IatrogénicaRESUMEN
Evidence has recently been reported of prion seeding activity in skin tissue from patients with sporadic Creutzfeldt-Jakob disease (sCJD). This is relevant information for infection control measures during surgery. The work uses very sensitive prion assays now available for medical research, and may soon be adapted to related neurodegenerative disorders.
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Síndrome de Creutzfeldt-Jakob/diagnóstico , Atención a la Salud , Priones/metabolismo , Piel/metabolismo , Síndrome de Creutzfeldt-Jakob/prevención & control , Humanos , Piel/patologíaRESUMEN
BACKGROUND: In all, there have been 178 variant Creutzfeldt-Jakob disease (vCJD) patients diagnosed in the UK, with an estimated maximum 1:2000 carriage rate based on archived appendix and tonsil tissue, implying that infection may be rare but carriage relatively frequent. Previous workers have identified that maintenance of surgical instruments in a humid atmosphere after use and prior to cleaning assists cleaning efficacy. Recently the Department of Health/Advisory Committee on Dangerous Pathogens UK have recommended a surgical instrument cleanliness threshold post cleaning of <5 µg protein per instrument side. AIM: To quantify cleanliness of neurosurgical instruments and to investigate cost-effective measures for improved cleaning. METHODS: Two instrument protein quantification methods were used: one based on the International Standard (15883 series) using sodium dodecyl sulphate elution and ortho-phthalaldehyde reaction, and a second in-situ protein fluorescence detection system (ProReveal) providing results per instrument side. In-vitro investigation of the efficacy of some commercial and in-house pre-clean wetting agents was undertaken using artificial test soil and stainless steel discs under standard conditions. In-vivo evaluation of best-performing in-vitro agents was undertaken on craniotomy sets. FINDINGS: ProReveal technology demonstrated that 163 out of 187 (87%) neurosurgical instruments had <5 µg residual protein per instrument side. The use of proprietary National Health Service plastic bags and sterile water-soaked wound pads were equivalent in efficacy to commercial pre-cleaning wetting products and significantly less expensive. CONCLUSION: Although we demonstrate low in-situ protein levels on neurosurgical instruments and the beneficial effects of keeping instruments moist, other cleaning critical-control points such as instrument loading patterns should also be monitored.
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Síndrome de Creutzfeldt-Jakob/epidemiología , Síndrome de Creutzfeldt-Jakob/prevención & control , Descontaminación/métodos , Enfermedad Iatrogénica/epidemiología , Enfermedad Iatrogénica/prevención & control , Control de Infecciones/métodos , Instrumentos Quirúrgicos , Descontaminación/economía , Humanos , Control de Infecciones/economía , Proteínas/análisis , Reino Unido/epidemiologíaAsunto(s)
Babesiosis/sangre , Bancos de Sangre/normas , Donantes de Sangre/legislación & jurisprudencia , Síndrome de Creutzfeldt-Jakob/sangre , Pruebas Hematológicas , Tamizaje Masivo , Infección por el Virus Zika/sangre , Babesia microti/genética , Babesia microti/aislamiento & purificación , Babesiosis/epidemiología , Babesiosis/parasitología , Babesiosis/prevención & control , Transfusión Sanguínea , Síndrome de Creutzfeldt-Jakob/prevención & control , Síndrome de Creutzfeldt-Jakob/transmisión , Femenino , Pruebas Hematológicas/tendencias , Humanos , Masculino , Tamizaje Masivo/tendencias , Mosquitos Vectores/virología , Puerto Rico/epidemiología , ARN Viral/sangre , Estados Unidos/epidemiología , United States Food and Drug Administration/legislación & jurisprudencia , Virus Zika/genética , Virus Zika/aislamiento & purificación , Infección por el Virus Zika/epidemiología , Infección por el Virus Zika/prevención & control , Infección por el Virus Zika/virologíaRESUMEN
BACKGROUND: Variant Creutzfeldt-Jakob disease (vCJD) has been transmitted by blood transfusion (TTvCJD). The US Food and Drug Administration (FDA) recommends deferring blood donors who resided in or traveled to 30 European countries where they may have been exposed to bovine spongiform encephalopathy (BSE) through beef consumption. Those recommendations warrant re-evaluation, because new cases of BSE and vCJD have markedly abated. STUDY DESIGN AND METHODS: The FDA developed a risk-ranking model to calculate the geographic vCJD risk using country-specific case rates and person-years of exposure of US blood donors. We used the reported country vCJD case rates, when available, or imputed vCJD case rates from reported BSE and UK beef exports during the risk period. We estimated the risk reduction and donor loss should the deferral be restricted to a few high-risk countries. We also estimated additional risk reduction by leukocyte reduction (LR) of red blood cells (RBCs). RESULTS: The United Kingdom, Ireland, and France had the greatest vCJD risk, contributing approximately 95% of the total risk. The model estimated that deferring US donors who spent extended periods of time in these three countries, combined with currently voluntary LR (95% of RBC units), would reduce the vCJD risk by 89.3%, a reduction similar to that achieved under the current policy (89.8%). Limiting deferrals to exposure in these three countries would potentially allow donations from an additional 100,000 donors who are currently deferred. CONCLUSION: Our analysis suggests that a deferral option focusing on the three highest risk countries would achieve a level of blood safety similar to that achieved by the current policy.
Asunto(s)
Donantes de Sangre , Seguridad de la Sangre , Transfusión Sanguínea , Síndrome de Creutzfeldt-Jakob/prevención & control , Selección de Donante , Animales , Bovinos , Síndrome de Creutzfeldt-Jakob/sangre , Síndrome de Creutzfeldt-Jakob/epidemiología , Femenino , Humanos , Masculino , Estados Unidos/epidemiologíaRESUMEN
The report provides a summary of the presentations at the Virus & TSE Safety Forum 2015 organized by the Parenteral Drug Association (PDA) and held in Cascais, Portugal, from 9 to 11 June, 2015. As with previous conferences of this series, the PDA Virus & TSE Safety Forum 2015 provided an excellent forum for the exchange of information and opinions between the industry, research organizations, and regulatory bodies. Regulatory updates on virus and TSE safety aspects illustrating current topics of discussion at regulatory agencies in Europe and the United States were provided; the conference covered emerging viruses and new virus detection systems that may be used for the investigation of human pathogenic viruses as well as the virus safety of cell substrates and of raw material of ovine/caprine or human origin. Progress of development and use of next-generation sequencing methods was shown by several examples. Virus clearance data illustrating the effectiveness of inactivation or removal methods were presented and data provided giving insight into the mechanism of action of these technologies. In the transmissible spongiform encephalopathy (TSE) part of the conference, the epidemiology of variant Creutzfeldt-Jakob disease was reviewed and an overview about diagnostic tests provided; current thinking about the spread and propagation of prions was presented and the inactivation of prions by disinfection (equipment) and in production of bovine-derived reagents (heparin) shown. The current report provides an overview about the outcomes of the 2015 PDA Virus & TSE Safety Forum, a unique event in this field.