Sterilization and Decontamination

2019 ◽  
Author(s):  
Sylvia Chegra ◽  
Martina N. Cummins
Keyword(s):  
Adverse Effect ◽  
Medical Devices ◽  
Microbial Contamination ◽  
Bacterial Spores ◽  
Cleaning Process ◽  
Infectious Agents ◽  
Toxic Chemical ◽  
Gas Plasma ◽  
Accredited Laboratories ◽  
Instructions For Use

Decontamination is the combination of processes (including cleaning, disinfection, and sterilization) used to make a re-usable item safe for medical use. It is important to have an understanding of the meaning of each of these terms as well as their application. Cleaning: a process to remove infectious agents and organic matter. The effectiveness of reducing microbial contamination will vary dependent upon the efficacy of the cleaning process and the initial bio- burden. It is important to note that this process does not necessarily destroy infectious agents and is a pre-requisite to disinfection and/ or sterilization. Disinfection: a process to reduce the number of viable infectious agents and which is commonly achieved either chemically or thermally. For some infectious agents (such as certain viruses and bacterial spores) it is not an effective method for inactivation and will not achieve the same level of reduction as is achieved through terminal sterilization. Sterilization: a process which renders an object free from viable infectious agents, including viruses and bacterial spores. Sterilization is achieved most commonly using a prescribed ratio of time, temperature, and steam or chemicals such as hydrogen peroxide, gas plasma, or ethylene oxide. The effective decontamination of re- usable medical devices is essential in reducing the risk of transmission of infectious agents with the chosen method of decontamination being detailed in the manufacturer’s decontamination guidance or instructions for use (IFU), supplied when a medical device is purchased. The guidance will reflect the validation that was carried out prior to the release of the product by accredited laboratories to ensure that the cleaning guidance is both effective and will not adversely affect the device. The aim of the decontamination process is to: 1. Reduce or completely remove microbial contamination to such a level that it is both safe to handle for staff and safe for further use on patients. 2. Ensure that there is no toxic chemical residue on the surface of the device that could cause adverse reactions when used on a patient. 3. Ensure that the decontamination process is compatible with the device and that it does not damage the device through the use of chemicals that can have an adverse effect on the device or by exposing it to either heat or water, which may cause damage.

Application of Hydrogen Peroxide Gas Plasma Method for Porous Polyurethane Sterilization

2007 ◽  
Vol 342-343 ◽  
pp. 905-908 ◽  
Author(s):  
Mi Hee Lee ◽  
Yeon I Woo ◽  
In Seop Lee ◽  
Jeong Koo Kim ◽  
Jong Chul Park
Keyword(s):  
Hydrogen Peroxide ◽  
Tissue Engineering ◽  
Medical Devices ◽  
Microbial Contamination ◽  
Polymer Scaffold ◽  
Plasma Method ◽  
Plasma Sterilization ◽  
Gas Plasma ◽  
Engineering Materials

Tissue-engineering must be either manufactured aseptically or sterilized after processing. To extend protection of medical devices against microbial contamination, various sterilization methods have been suggested. Hydrogen peroxide gas plasma sterilization has been applied in hospitals worldwide for almost a decade. In this study, we investigated the sterilization efficacy of hydrogen peroxide gas plasma sterilizer with porous polyurethane sample. The result is suggested that hydrogen peroxide gas plasma can be applicable to the sterilization of polymer scaffold for tissue engineering materials.

KAZAKHSTAN'S MARKET POSITIONS WITHIN THE EAEU

2022 ◽  
pp. 4-8
Author(s):  
А.М. САРСЕМБАЕВА
Keyword(s):  
Medical Devices ◽  
Registration Process ◽  
Accredited Laboratories

В данной статье рассмотрена проблема реализации процесса регистрации медицинских изделий в рамках ЕАЭС. Проанализирован рынок аккредитованных лаборатории, способных проводить испытания для дальнейшего процесса регистрации. А также стоит обратить внимание на нехватку лабораторий, способных проводить различные испытания на безопасность медицинских изделий в Казахстане в рамках ЕАЭС. This article discusses the problem of implementing the registration process of medical devices within the EAEU. The market of accredited laboratories capable of conducting tests for the further registration process is analyzed. And it is also worth paying attention to the shortage of laboratories capable of conducting various tests for the safety of medical devices in Kazakhstan within the framework of the EAEU.

scholarly journals Listeria Monocytogenes Contamination Study in Food from Plant Origin in the Market

2019 ◽  
Vol 4 (3) ◽  
Keyword(s):  
Listeria Monocytogenes ◽  
Microbial Contamination ◽  
Chemical Contamination ◽  
Minimal Processing ◽  
Traditional Markets ◽  
Fresh Food ◽  
Accredited Laboratories ◽  
Pathogenic Microbes ◽  
Random Method ◽  
Bean Sprouts

Fresh food from plants is fresh food that is consumed directly or after cutting, I have minimal processing. Therefore PSAT to be consumed must be safe from aspects of microbial contamination and physical chemical contamination. There are several types of pathogenic microbes, which can contaminate PSAT and can cause disease disorders. One microbe, which includes pathogenic microbes and potentially contaminates PSAT, is Listeria monocytogenes. Microbes Listeria monocytogenes are pathogenic in certain groups of people in small amounts. To know the prevalence of Listeria monocytogenes, studies were carried out, by taking samples at locations, and selected commodities. The locations chosen are West Java, Banten and DKI Jakarta in two traditional markets in each province. While the selected commodities are bean sprouts, tomatoes and cabbage. Sampling was carried out by random method, with the population in accordance with the number of vegetable traders in that location. Testing of samples for Listeria monocytogenes contamination is carried out in accredited laboratories. From the results of testing of 300 (three hundred) samples, consisting of 100 samples of bean sprouts, 100 samples of tomatoes, and 100 samples of cabbage, all test samples were declared negative or unexposed to Listeria monocytogenes.

scholarly journals The Effect of Disinfectants Absorption and Medical Decontamination on the Mechanical Performance of 3D-Printed ABS Parts

Polymers ◽  
2021 ◽  
Vol 13 (23) ◽  
pp. 4249
Author(s):  
Diana Popescu ◽  
Florin Baciu ◽  
Catalin Gheorghe Amza ◽  
Cosmin Mihai Cotrut ◽  
Rodica Marinescu
Keyword(s):  
3D Printing ◽  
Medical Devices ◽  
Mechanical Performance ◽  
Acrylonitrile Butadiene Styrene ◽  
Extrusion Process ◽  
Air Gaps ◽  
Safety Issues ◽  
Gas Plasma ◽  
3D Printed ◽  
Butadiene Styrene

Producing parts by 3D printing based on the material extrusion process determines the formation of air gaps within layers even at full infill density, while external pores can appear between adjacent layers making prints permeable. For the 3D-printed medical devices, this open porosity leads to the infiltration of disinfectant solutions and body fluids, which might pose safety issues. In this context, this research purpose is threefold. It investigates which 3D printing parameter settings are able to block or reduce permeation, and it experimentally analyzes if the disinfectants and the medical decontamination procedure degrade the mechanical properties of 3D-printed parts. Then, it studies acetone surface treatment as a solution to avoid disinfectants infiltration. The absorption tests results indicate the necessity of applying post-processing operations for the reusable 3D-printed medical devices as no manufacturing settings can ensure enough protection against fluid intake. However, some parameter settings were proven to enhance the sealing, in this sense the layer thickness being the most important factor. The experimental outcomes also show a decrease in the mechanical performance of 3D-printed ABS (acrylonitrile butadiene styrene) instruments treated by acetone cold vapors and then medical decontaminated (disinfected, cleaned, and sterilized by hydrogen peroxide gas plasma sterilization) in comparison to the control prints. These results should be acknowledged when designing and 3D printing medical instruments.

scholarly journals Analysis of improved cleaning process targeting tough spot around the yogurt filling machine

2021 ◽  
Vol 245 ◽  
pp. 03005
Author(s):  
Gu Yan ◽  
Zhao Longtao
Keyword(s):  
Food Industry ◽  
Room Temperature ◽  
Microbial Contamination ◽  
Risk Control ◽  
Cleaning Process ◽  
Seal Ring ◽  
Barrier Structure ◽  
Great Loss ◽  
Company Limited ◽  
Long Time

The dairy industry produces sterilized room temperature yogurt. In the process of water flushing filling machine of valves ABC structure, the milk pressed by the seal ring of plunger valve A cannot be cleaned for a long time, causing scaling and increasing the risk of pollution. In order to avoid the risk, the filling machine need to be manually disassembled and cleaned which takes more than 4 hours, resulting in great loss of efficiency. This paper integrates the aseptic tank technology and filling technology of China Mengniu Dairy Company Limited. On this basis, the cleaning process of the sterile[1] normal temperature yogurt filling machine is improved, the technology of water flushing valve A is innovated. It solves the problem of milk scale caused by the pressing of ring of valve A which is hard to clean, therefore minimizes the risk of microbial contamination. The improved process has been tested and applied to sterilized normal temperature yoghurt. The risk control of pollution products with high pectin fiber and even the filling machine with steam barrier structure in food industry is also applicable, which has certain promotion value.

scholarly journals Utilization of Ozone for the Improvement of Mentha piperita L. Quality by Reduction of Microbial Load and Impact of the Process on the Herb Properties

2020 ◽  
Vol 24 (2) ◽  
pp. 156-164
Author(s):  
Piotr Antos ◽  
Tomasz Piechowiak ◽  
Krzysztof Tereszkiewicz ◽  
Maciej Balawejder
Keyword(s):  
Adverse Effect ◽  
Essential Oils ◽  
Sensory Evaluation ◽  
Microbial Contamination ◽  
Food Poisoning ◽  
Microbial Load ◽  
Mentha Piperita

AbstractHerbs can be contaminated with microorganisms, which affects their quality while increasing the risk of food poisoning. Thus, there is a need for efficient decontamination techniques. In this study, the microbial load was reduced in peppermint herb (Mentha piperita L.) exposed to ozone at 10 ppm for 60 minutes. The quality of the ozonated herb was assessed by the determination of microbial load and essential oils content. Total microbial content was reduced by 4 log cfu g−1 of the microorganisms whereas the contamination with molds was reduced from 10.07 log cfu g−1 of the microorganisms to zero. Moreover, sensory evaluation of the herb aroma was conducted. These characteristics were not significantly affected by the treatment. Therefore, ozone can be used to improve the peppermint herb quality by reduction of the microbial contamination of peppermint herb while having no adverse effect on the herb aroma.

Optimizing Epidemiology–Laboratory Collaborations

2019 ◽  
pp. 187-212
Author(s):  
M. Shannon Keckler ◽  
Reynolds M. Salerno ◽  
Michael W. Shaw
Keyword(s):  
Infectious Disease ◽  
Disease Control ◽  
Study Design ◽  
Disease Outbreak ◽  
Field Investigation ◽  
Infectious Agents ◽  
Toxic Chemical ◽  
Infectious Disease Outbreak ◽  
Control And Prevention ◽  
Future Outbreak

Whether a field investigation involves a suspected or known infectious disease outbreak or a potential exposure to a toxic chemical or radionuclide, its success often depends on contributions from relevant laboratories; thus, strong collaborations between epidemiologists and laboratory scientists are critical. Outbreak investigators should contact scientists in relevant laboratories as soon as possible, preferably before deployment to the investigation site because early consultations with laboratory experts is often essential to study design. Many local laboratories can perform the more common tests needed, especially those for common infectious agents, whereas laboratories at the Centers for Disease Control and Prevention can provide backup support or more specialized services when appropriate. Strong collaborations between field epidemiologists and laboratory scientists can enhance the performance of future outbreak investigation teams.

Preliminary Study of Ozone Utilization in Elimination of Bacterial Contamination in Metalworking Fluids

2013 ◽  
Vol 581 ◽  
pp. 143-147
Author(s):  
Kristina Gerulova ◽  
Eva Buranská ◽  
Ondrej Tatarka ◽  
Zuzana Szabova
Keyword(s):  
Adverse Effect ◽  
Ozone Concentration ◽  
Bacterial Contamination ◽  
Microbial Contamination ◽  
Metalworking Fluids ◽  
Extreme Conditions ◽  
Quality Performance ◽  
Preliminary Study ◽  
Micro Organisms

Metalworking fluids (MWFs) are used during machining to prolong the life of the tool, carry away debris, and protect the surfaces of work pieces. During their lifetime they are prone to intensive microbial deterioration. Microbial contamination can be a problem, primarily because of potentional adverse effect to the operators health and effect on a fluid quality, performance and economics. Bactericides are added to control the growth of micro-organisms. The paper deals with possible utilization of ozone for sterilization of MWFs to avoid presence of biocides. There were tested 16 MWFs for their reaction to ozone application in extreme conditions (concentration of MWF 1% (v/v), ozone concentration 15 g hour-1, application of ozone 4 hours). After, was realized pilot sanitation of selected in-use MWF for elimination of presence bacterias by applying lower concentration of O3, there were measured few parameters to control the quality of treatment fluid.

When human factors and design unite: using visual language and usability testing to improve instructions for a home-use medication infusion pump

2014 ◽  
Vol 3 (1) ◽  
pp. 254-260 ◽  
Author(s):  
Natalie Abts ◽  
Angelica Hernandez ◽  
Stanley Caplan ◽  
A. Zachary Hettinger ◽  
Ethan Larsen ◽  
...  
Keyword(s):  
Home Environment ◽  
Medical Devices ◽  
Infusion Pump ◽  
Healthcare Facility ◽  
Second Phase ◽  
Heuristic Evaluation ◽  
User Testing ◽  
More Care ◽  
Two Phases ◽  
Instructions For Use

Use of medical devices in the home that had previously been used in a healthcare facility is increasing as more care is being transferred to the home environment. To accommodate these changes, instructions for use (IFU) for these devices must be clear and understandable for patients and caregivers to be able to operate them safety. IFUs that use illustrations and graphics rather than text to convey information may make user guides more accessible. This project consisted of two phases to determine the appropriate design of a visual user guide (VUG). During the first phase, a heuristic evaluation of the manufacturer’s IFU for an infusion pump was conducted. In the second phase, the heuristic evaluation results were used to inform the development of a VUG. Two rounds of iterative user testing were then conducted with a sample of target end users, with each round resulting in updates to the VUG. Findings demonstrated both major deficiencies in the usability of the manufacturer’s IFU, and improvements in helpfulness ratings and subjective participant feedback as the VUG was updated based on testing recommendations. The study demonstrates the value of visual guides for patients using medical devices and the use of discount usability techniques to identify major design issues.

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