Indications and the requirements for single-use medical gloves

Aim: While the requirements for single-use gloves for staff protection are clearly defined, the conventional medical differentiation between “sterile surgical gloves” used during surgical procedures and “single-use medical gloves” used in non-sterile medical areas does not adequately define the different requirements in these two areas of use. Sterilization of single-use medical gloves is not performed if sterility is not required; thus, another terminology must be found to identify the safety quality of non-sterile single-use medical gloves. Therefore, the labeling of such gloves should reflect this situation, by introducing the term “pathogen-free” single-use glove. The hygienic safety of such a glove would be attainable by ensuring aseptic manufacturing conditions during manufacturing and control of pathogen load of batch controls after fabrication. Proposed recommendation: Because single-use gloves employed in non-sterile areas come into contact not only with intact skin but also with mucous membranes, no potential pathogens should be detectable in 100 mL of rinse sample. In order to declare such gloves as pathogen-free we suggest absence of the indicator species S. aureus and E. coli. In addition, the total CFU count should be evaluated, since a high load indicates lack of optimal hygiene during the manufacturing process. Based on the requirements for potable water and findings obtained from investigations of the bacterial load of such gloves after manufacturing, the here suggested limit for the total bacterial count of <102 CFU/mL of rinse sample per glove seems realistic. Keywords: singl
e-use medical gloves, indications, requirements, definitions, “germ-poor” single-use gloves, pathogen-free single-use gloves

REFERENCE:
Kramer, A., & Assadian, O. (2016). Indications and the requirements for single-use medical gloves. GMS Hygiene and Infection Control, 11, Doc01. http://doi.org/10.3205/dgkh000261
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Engineered nanomaterials: toward effective safety management in research laboratories

Background: It is still unknown which types of nanomaterials and associated doses represent an actual danger to humans and environment. Meanwhile, there is consensus on applying the precautionary principle to these novel materials until more information is available. To deal with the rapid evolution of research, including the fast turnover of collaborators, a user-friendly and easy-to-apply risk assessment tool offering adequate preventive and protective measures has to be provided.
Results: Based on new information concerning the hazards of engineered nanomaterials, we improved a previously developed risk assessment tool by following a simple scheme to gain in efficiency. In the first step, using a logical decision tree, one of the three hazard levels, from H1 to H3, is assigned to the nanomaterial. Using a combination of decision trees and matrices, the second step links the hazard with the emission and exposure potential to assign one of the three nanorisk levels (Nano 3 highest risk; Nano 1 lowest risk) to the activity. These operations are repeated at each process step, leading to the laboratory classification. The third step provides detailed preventive and protective measures for the determined level of nanorisk.
Conclusions: We developed an adapted simple and intuitive method for nanomaterial risk management in research laboratories. It allows classifying the nanoactivities into three levels, additionally proposing concrete preventive and protective measures and associated actions. This method is a valuable tool for all the participants in nanomaterial safety. The users experience an essential learning opportunity and increase their safety awareness. Laboratory managers have a reliable tool to obtain an overview of the operations involving nanomaterials in their laboratories; this is essential, as they are responsible for the employee safety, but are sometimes unaware of the works performed. Bringing this risk to a three-band scale (like other types of risks such as biological, radiation, chemical, etc.) facilitates the management for occupational health and safety specialists. Institutes and school managers can obtain the necessary information to implement an adequate safety management system. Having an easy-to-use tool enables a dialog between all these partners, whose semantic and priorities in terms of safety are often different.

REFERENCE:
Groso, Amela et al. “Engineered Nanomaterials: Toward Effective Safety Management in Research Laboratories.” Journal of Nanobiotechnology 14 (2016): 21. PMC. Web. 18 Aug. 2016.

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#UANL: 2º Taller "Control de Riesgos Biológicos en Laboratorios de Investigación"

2º Taller "Control de Riesgos Biológicos en Laboratorios de Investigación"

12 de Septiembre de 2016

Facultad de Ciencias Biológicas, UANL.

Ciudad Universitaria, San Nicolás de los Garza, Nuevo León.

=>  DESCARGAR PROGRAMA PDF  <=

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Use of Protective Gloves in Nail Salons in Manhattan, New York City

Objectives: Nail salon owners in New York City (NYC) are required to provide their workers with gloves and it is their responsibility to maintain healthy, safe working spaces for their employees. The purpose of this study was to determine the frequency with which nail salon workers wear protective gloves.
Methods: A Freedom of Information Law request was submitted to New York Department of State’s Division of Licensing Services for a full list of nail salons in Manhattan, NYC. A sample population of 800 nail salons was identified and a simple random sample (without replacement) of 30% (n=240) was selected using a random number generator. Researchers visited each nail salon from October to December of 2015, posing as a potential customer to determine if nail salon workers were wearing gloves.
Results: Among the 169 salons in which one or more workers was observed providing services, a total of 562 workers were observed. For 149 salons, in which one or more worker was observed providing services, none of the workers were wearing gloves. In contrast, in six of the salons observed, in which one or more workers was providing services, all of the workers (1 in 2 sites, 2 in 1 site, 3 in 2 sites, and 4 in 1 site) were wearing gloves. Almost three-quarters of the total number of workers observed (n=415, 73.8%) were not wearing gloves.
Conclusions: The findings of this study indicate that, despite recent media attention and legislation, the majority of nail salon workers we observed were not wearing protective gloves when providing services.

REFERENCE:
Basch, Corey et al. “Use of Protective Gloves in Nail Salons in Manhattan, New York City.” Journal of Preventive Medicine and Public Health 49.4 (2016): 249–251. PMC. Web. 18 Aug. 2016.

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Performance analysis of exam gloves used for aseptic rodent surgery

Aseptic technique includes the use of sterile surgical gloves for survival surgeries in rodents to minimize the incidence of infections. Exam gloves are much less expensive than are surgical gloves and may represent a cost-effective, readily available option for use in rodent surgery. This study examined the effectiveness of surface disinfection of exam gloves with 70% isopropyl alcohol or a solution of hydrogen peroxide and peracetic acid (HP-PA) in reducing bacterial contamination. Performance levels for asepsis were met when gloves were negative for bacterial contamination after surface disinfection and sham 'exertion' activity. According to these criteria, 94% of HP-PA-disinfected gloves passed, compared with 47% of alcohol-disinfected gloves. In addition, the effect of autoclaving on the integrity of exam gloves was examined, given that autoclaving is another readily available option for aseptic preparation. Performance criteria for glove integrity after autoclaving consisted of: the ability to don the gloves followed by successful simulation of wound closure and completion of stretch tests without tearing or observable defects. Using this criteria, 98% of autoclaved nitrile exam gloves and 76% of autoclaved latex exam gloves met performance expectations compared with the performance of standard surgical gloves (88% nitrile, 100% latex). The results of this study support the use of HP-PA-disinfected latex and nitrile exam gloves or autoclaved nitrile exam gloves as viable cost-effective alternatives to sterile surgical gloves for rodent surgeries.

REFERENCE:

LeMoine DM, et al. Performance analysis of exam gloves used for aseptic rodent surgery. J Am Assoc Lab Anim Sci. 2015 May;54(3):311-6.

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Gain-of-Function Research: Ethical Analysis

Gain-of-function (GOF) research involves experimentation that aims or is expected to (and/or, perhaps, actually does) increase the transmissibility and/or virulence of pathogens. Such research, when conducted by responsible scientists, usually aims to improve understanding of disease causing agents, their interaction with human hosts, and/or their potential to cause pandemics. The ultimate objective of such research is to better inform public health and preparedness efforts and/or development of medical countermeasures. Despite these important potential benefits, GOF research (GOFR) can pose risks regarding biosecurity and biosafety. In 2014 the administration of US President Barack Obama called for a "pause" on funding (and relevant research with existing US Government funding) of GOF experiments involving influenza, SARS, and MERS viruses in particular. With announcement of this pause, the US Government launched a "deliberative process" regarding risks and benefits of GOFR to inform future funding decisions-and the US National Science Advisory Board for Biosecurity (NSABB) was tasked with making recommendations to the US Government on this matter. As part of this deliberative process the National Institutes of Health commissioned this Ethical Analysis White Paper, requesting that it provide (1) review and summary of ethical literature on GOFR, (2) identification and analysis of existing ethical and decision-making frameworks relevant to (i) the evaluation of risks and benefits of GOFR, (ii) decision-making about the conduct of GOF studies, and (iii) the development of US policy regarding GOFR (especially with respect to funding of GOFR), and (3) development of an ethical and decision-making framework that may be considered by NSABB when analyzing information provided by GOFR risk-benefit assessment, and when crafting its final recommendations (especially regarding policy decisions about funding of GOFR in particular). The ethical and decision-making framework ultimately developed is based on the idea that there are numerous ethically relevant dimensions upon which any given case of GOFR can fare better or worse (as opposed to there being necessary conditions that are either satisfied or not satisfied, where all must be satisfied in order for a given case of GOFR to be considered ethically acceptable): research imperative, proportionality, minimization of risks, manageability of risks, justice, good governance (i.e., democracy), evidence, and international outlook and engagement. Rather than drawing a sharp bright line between GOFR studies that are ethically acceptable and those that are ethically unacceptable, this framework is designed to indicate where any given study would fall on an ethical spectrum-where imaginable cases of GOFR might range from those that are most ethically acceptable (perhaps even ethically praiseworthy or ethically obligatory), at one end of the spectrum, to those that are most ethically problematic or unacceptable (and thus should not be funded, or conducted), at the other. The aim should be that any GOFR pursued (and/or funded) should be as far as possible towards the former end of the spectrum.

REFERENCE:
Selgelid MJ. Gain-of-Function Research: Ethical Analysis. Sci Eng Ethics. 2016 Aug 8. doi:10.1007/s11948-016-9810-1

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Soliciting Stakeholder Input for a Revision of Biosafety in Microbiological and Biomedical Laboratories (BMBL): Proceedings of a Workshop.

Since its publication by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) in 1984, Biosafety in Microbiological and Biomedical Laboratories (BMBL) has become the cornerstone of the practice of biosafety in the United States and in many countries around the world. The BMBL has been revised periodically over the past three decades to refine the guidance it provides based on new knowledge and experiences—allowing it to remain a relevant, valuable, and authoritative reference for the microbiological and biomedical community. Seven years after the release of the BMBL 5th Edition, NIH and CDC are considering a revision based on the comments of a broader set of stakeholders. At the request of NIH, the National Academies of Sciences, Engineering and Medicine conducted a virtual town hall meeting from 4 April to 20 May 2016 to allow BMBL users to share their thoughts on the BMBL in general and its individual sections and appendices. Specifically, users were asked to indicate what information they think should be added, revised, or deleted. Major themes from the virtual town hall meeting were further discussed in a workshop held on 12 May 2016 in Washington, DC. This document encapsulates the discussion of the major comments on the BMBL that were posted on the virtual town hall prior to 12 May 2016 and the various BMBL comments and issues related to biosafety that were raised during the workshop by participants who attended the meeting in Washington DC and those who listened to the live webcast.

REFERENCE:
Board on Agriculture and Natural Resources; Division on Earth and Life Studies; National Academies of Sciences, Engineering, and Medicine. Soliciting Stakeholder Input for a Revision of Biosafety in Microbiological and Biomedical Laboratories (BMBL): Proceedings of a Workshop. WASHINGTON (DC): National Academies Press (US); 2016 Jul.
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