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https://www.readbyqxmd.com/read/28089965/increasing-patient-safety-by-closing-the-sterile-production-gap-part-2-implementation
#1
James Agalloco
Terminal sterilization is considered the preferred means for the production of sterile drug products as it affords enhanced safety for the patient as the formulation is filled into its final container, sealed and sterilized. Despite the obvious patient benefits, the use of terminal sterilization is artificially constrained by unreasonable expectations for the minimum time-temperature process to be used. The core misunderstanding with terminal sterilization is a fixation that destruction of a high population of a resistant biological indicator is required...
January 15, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28089964/increasing-patient-safety-by-closing-the-sterile-production-part-1-introduction
#2
James Agalloco
Terminal sterilization is considered the preferred means for the production of sterile drug products as it affords enhanced safety for the patient as the formulation is filled into its final container, sealed and sterilized. Despite the obvious patient benefits, the use of terminal sterilization is artificially constrained by unreasonable expectations for the minimum time-temperature process to be used. The core misunderstanding with terminal sterilization is a fixation that destruction of a high population of a resistant biological indicator is required...
January 15, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28070472/utilizing-the-veraflo%C3%A2-instillation-negative-pressure-wound-therapy-system-with-advanced-care-for-a-case-study
#3
Rita K Driver
BACKGROUND:  Mankind has always suffered wounds throughout time due to trauma, disease, and lifestyles. Many wounds are non-healing and have continued to be challenging. However, utilizing advanced wound care treatments, such as negative pressure wound treatment with instillation and dwell time (NPWTi-d), has proven beneficial. NPWTi-d is indicated in a variety of wounds, such as trauma, surgical, acute, pressure injuries, diabetic foot ulcers, and venous leg ulcers. Bacteria and bioburden interrupts wound healing by increasing the metabolic needs, ingesting, and robbing the necessary nutrients and oxygen...
November 30, 2016: Curēus
https://www.readbyqxmd.com/read/28069512/minocycline-enhances-the-mesenchymal-stromal-stem-cell-pro-healing-phenotype-in-triple-antimicrobial-loaded-hydrogels
#4
Alberto Daniel Guerra, Warren E Rose, Peiman Hematti, W John Kao
: Mesenchymal stromal/stem cells (MSCs) have demonstrated pro-healing properties including an anti-inflammatory cytokine profile and the promotion of angiogenesis via expression of growth factors in pre-clinical models. MSCs encapsulated in poly(ethylene glycol) diacrylate (PEGdA) and thiolated gelatin poly(ethylene glycol) (Gel-PEG-Cys) crosslinked hydrogels have led to controlled cellular presentation at wound sites with favorable wound healing outcomes. However, the therapeutic potential of MSC-loaded hydrogels may be limited by non-specific protein adsorption on the delivery matrix that could facilitate the initial adhesion of microorganisms and subsequent virulent biofilm formation...
January 6, 2017: Acta Biomaterialia
https://www.readbyqxmd.com/read/28058525/the-visual-assessment-of-broth-cultures-for-tissue-bank-samples
#5
Kerry Varettas
The bioburden screening process of allograft musculoskeletal tissue samples received at the South Eastern Area Laboratory Services includes the routine use of solid agar and cooked meat (CM) broth media. CM has been routinely sub-cultured onto solid agar plates after aerobic incubation at 35 °C. This study will evaluate whether a visual assessment of CM can replace sub-culture by an in vitro inoculation and a prospective study. Eight challenge organisms were serially diluted and inoculated into CM. The average inoculum of 0...
January 5, 2017: Cell and Tissue Banking
https://www.readbyqxmd.com/read/28050814/what-orthopaedic-operating-room-surfaces-are-contaminated-with-bioburden-a-study-using-the-atp-bioluminescence-assay
#6
Raveesh Daniel Richard, Thomas R Bowen
BACKGROUND: Contaminated operating room surfaces can increase the risk of orthopaedic infections, particularly after procedures in which hardware implantation and instrumentation are used. The question arises as to how surgeons can measure surface cleanliness to detect increased levels of bioburden. This study aims to highlight the utility of adenosine triphosphate (ATP) bioluminescence technology as a novel technique in detecting the degree of contamination within the sterile operating room environment...
January 3, 2017: Clinical Orthopaedics and related Research
https://www.readbyqxmd.com/read/28045778/a-14-year-audit-and-analysis-of-human-skin-allograft-discards
#7
Jordan Spradbrow, Matthew Etchells, Robert Cartotto, Alison Halliday, Yulia Lin, Andrew Simor, Raj Visvalingam, Jeannie Callum
The objective of this study was to review the incidence of skin allograft discard and bacterial contamination due to donor bioburden at the Ontario Professional Firefighters Skin Bank over a 14-year period. We sought to determine whether modifications to our prerecovery donor preparation process have been effective in reducing skin bioburden and identify other potential risk factors of allograft contamination. A retrospective review of all skin donors (n = 259) processed from 2002 to 2015 was performed. Multivariate logistic regression was used to determine whether donor-related factors and procurement-related factors were significantly associated with microbial contamination predisinfection and discard secondary to contamination...
December 30, 2016: Journal of Burn Care & Research: Official Publication of the American Burn Association
https://www.readbyqxmd.com/read/28024852/a-model-for-choosing-an-automated-ultraviolet-c-disinfection-system-and-building-a-case-for-the-c-suite-two-case-reports
#8
Maureen Spencer, Michelle Vignari, Elizabeth Bryce, Helen Boehm Johnson, Loretta Fauerbach, Denise Graham
Environmental disinfection has become the new frontier in the ongoing battle to reduce the risk of health care-associated infections. Evidence demonstrating the persistent contamination of environmental surfaces despite traditional cleaning and disinfection methods has led to the widespread acceptance that there is both a need for reassessing traditional cleaning protocols and for using secondary disinfection technologies. Ultraviolet-C (UV-C) disinfection is one type of no-touch technology shown to be a successful adjunct to manual cleaning in reducing environmental bioburden...
December 23, 2016: American Journal of Infection Control
https://www.readbyqxmd.com/read/27987968/gamma-sterilization-of-diclofenac-sodium-loaded-n-trimethyl-chitosan-nanoparticles-for-ophthalmic-use
#9
Rathapon Asasutjarit, Thitaree Theerachayanan, Prartana Kewsuwan, Sukitaya Veeranondha, Asira Fuongfuchat, Garnpimol C Ritthidej
This study was conducted to investigate the effect of gamma irradiation on physicochemical properties of N-trimethyl chitosan (TMC), diclofenac sodium (DC) and diclofenac sodium loaded N-trimethylchitosan nanoparticles (DC-TMCNs), and to determine suitable doses of gamma rays for sterilization of DC-TMCNs. Physicochemical properties of TMC, DC and DC-TMCNs before and after exposure to gamma rays at various doses were investigated. It was found that gamma irradiation at doses of 5-25kGy did not cause any significant changes in physical and chemical properties of TMC, DC and DC-TMCNs...
February 10, 2017: Carbohydrate Polymers
https://www.readbyqxmd.com/read/27974628/quantitative-microbial-risk-assessment-of-pharmaceutical-products
#10
Mostafa Essam Eissa
Monitoring of microbiological quality in the pharmaceutical industry is an important criterion that is required to justify safe product release to the drug market. Good manufacturing practice (GMP) and efficient control on bioburden level of product components are critical parameters that influence microbiological cleanliness of medicinal products. However, since microbial dispersion through the samples follows Poisson distribution, the rate of detection of microbiologically defective samples lambda (λ) decreases when the number of defective units per batch decreases...
December 14, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27922787/hydro-responsive-wound-dressings-simplify-t-i-m-e-wound-management-framework
#11
Karen Ousey, Alan A Rogers, Mark G Rippon
The development of wound management protocols and guidelines such as the T.I.M.E. acronym are useful tools to aid wound care practitioners deliver effective wound care. The tissue, infection/inflammation, moisture balance and edge of wound (T.I.M.E.) framework provides a systematic approach for the assessment and management of the majority of acute and chronic wounds. The debridement of devitalised tissue from the wound bed, the reduction in wound bioburden and effective management of wound exudate - i.e., wound bed preparation - are barriers to wound healing progression that are targeted by T...
December 2016: British Journal of Community Nursing
https://www.readbyqxmd.com/read/27912981/examining-the-association-between-surface-bioburden-and-frequently-touched-sites-in-intensive-care
#12
C E Adams, J Smith, V Watson, C Robertson, S J Dancer
BACKGROUND: Critical care patients are at increased risk of infection. Near-patient surfaces act as reservoirs of microbial soil, which may contain pathogens. AIM: To correlate soil levels with hand-touch frequency of near-patient sites in an intensive care unit (ICU). METHODS: Five sites around each bed in a 10-bed ICU were screened for total microbial soil (cfu/cm(2)) and Staphylococcus aureus every month for 10 months. Selected sites were infusion pump and cardiac monitor, left and right bedrails, and bed table...
January 2017: Journal of Hospital Infection
https://www.readbyqxmd.com/read/27876528/the-impact-of-lens-care-solutions-on-corneal-epithelial-changes-during-daily-silicone-hydrogel-contact-lens-wear-as-measured-by-in-vivo-confocal-microscopy
#13
Xiaolin Zhang, Christine Marchetti, Jessica Lee, Yan Sun, Sara Debanne, Ying Jiang, Jami Kern, Mark Harrod, Beth Ann Benetz, Eric Pearlman, Loretta Szczotka-Flynn
PURPOSE: To assess corneal epithelial microstructure via confocal microscopy and determine if cellular changes are associated with lens care solutions during daily wear of silicone hydrogel contact lenses. METHODS: Corneal in vivo confocal microscopy with the Nidek ConfoScan4 was performed at baseline and after 5 months of lotrafilcon A daily contact lens wear. Enrolled participants were randomized to use either a polyhexamethylene biguanide (PHMB) preserved multipurpose care solution (MPS) or a peroxide based solution system...
February 2017: Contact Lens & Anterior Eye: the Journal of the British Contact Lens Association
https://www.readbyqxmd.com/read/27844457/application-of-the-atp-assay-to-rapidly-assess-cleanliness-of-spacecraft-surfaces-a-path-to-set-a-standard-for-future-missions
#14
James N Benardini, Kasthuri Venkateswaran
The National Aeronautics and Space Administration (NASA) measures and validates the biological cleanliness of spacecraft surfaces by counting endospores using the NASA standard assay (NSA). NASA has also approved an adenosine-5'-triphosphate (ATP)-based detection methodology as a means to prescreen surfaces for the presence of microbial contamination, prior to the spore assay. During Mars Science Laboratory (MSL) spacecraft assembly, test, and launch operations, 4853 surface samples were collected to verify compliance with the bioburden requirement at launch...
December 2016: AMB Express
https://www.readbyqxmd.com/read/27817762/improvement-of-hand-hygiene-quality-and-compliance-using-bioburden-measurement-and-online-feedback-in-germany
#15
Frank Günther, Kai Rudolph, Uwe Frank, Nico T Mutters
To improve compliance with hand hygiene, a novel method with inclusion of an online reporting system was developed, comprising measurement of total hand bioburden, anonymous online feedback, and onsite training. The intervention significantly improved both compliance and quality of hand hygiene and reduced Staphylococcus aureus incidence. Infect Control Hosp Epidemiol 2016;1-4.
November 7, 2016: Infection Control and Hospital Epidemiology
https://www.readbyqxmd.com/read/27800587/evaluation-of-antibiotic-pressurized-pulse-lavage-for-contaminated-retromuscular-abdominal-wall-reconstruction
#16
Arnab Majumder, Heidi J Miller, Parita Patel, Yuhsin V Wu, Heidi L Elliott, Yuri W Novitsky
BACKGROUND: Despite patient risk factors such as diabetes and obesity, contamination during surgery remains a significant cause of infections and subsequent wound morbidity. Pressurized pulse lavage (PPL) has been utilized as a method to reduce bacterial bioburden with promising results in many fields. Although existing methods of lavage have been utilized during abdominal operations, no studies have examined the use of PPL during complex hernia repair. METHODS: Patients undergoing abdominal wall reconstruction (AWR) in clean-contaminated or contaminated fields with antibiotic PPL, from January 2012 to May 2013, were prospectively evaluated...
October 31, 2016: Surgical Endoscopy
https://www.readbyqxmd.com/read/27761677/tissue-recovery-practices-and-bioburden-a-systematic-review
#17
REVIEW
S Brubaker, K Lotherington, Jie Zhao, B Hamilton, G Rockl, A Duong, A Garibaldi, N Simunovic, D Alsop, D Dao, R Bessemer, O R Ayeni
For successful transplantation, allografts should be free of microorganisms that may cause harm to the allograft recipient. Before or during recovery and subsequent processing, tissues can become contaminated. Effective tissue recovery methods, such as minimizing recovery times (<24 h after death) and the number of experienced personnel performing recovery, are examples of factors that can affect the rate of tissue contamination at recovery. Additional factors, such as minimizing the time after asystole to recovery and the total time it takes to perform recovery, the type of recovery site, the efficacy of the skin prep performed immediately prior to recovery of tissue, and certain technical recovery procedures may also result in control of the rate of contamination...
December 2016: Cell and Tissue Banking
https://www.readbyqxmd.com/read/27757727/analysis-of-the-effectiveness-of-sodium-hypochlorite-decontamination-of-cadaveric-human-tissues-at-retrieval
#18
Adolfo Paolin, Diletta Trojan, Antonio Carniato, Fabio Tasca, Ervino Massarin, Alessandro Tugnoli, Elisa Cogliati
Bacterial contamination of tissues retrieved from cadaveric donors is a common feature worldwide, and every tissue bank, albeit using different methods, conducts decontamination to guarantee safe tissues suitable for clinical use. The effectiveness of the methods used to eradicate pathogens differs. In order to reduce the tissue bioburden at retrieval, we have introduced a new method involving rinsing tissues in a sodium hypochlorite solution. To test its effectiveness we analyzed two comparable groups of tissues: Group A: 1881 tissues, all rinsed with isotonic saline solution after retrieval, and Group B: 1968 tissues immersed in an isotonic saline solution containing sodium hypochlorite (final concentration 0...
December 2016: Cell and Tissue Banking
https://www.readbyqxmd.com/read/27731824/microbial-and-chemical-analysis-of-illicit-drugs-samples-confiscated-from-different-areas-of-pakistanmicrobial-and-chemical-analysis-of-illicit-drugs-samples-confiscated-from-different-areas-of-pakistan
#19
Shahzad Hussain, Zainab Khattak, Sidra Mahmood, Farnaz Malik, Humayun Riaz, Syed Atif Raza, Samiullah Khan
The microbial and chemical analysis of illicit drug samples from different areas of Pakistan i.e. Quetta, Karachi, Lahore and Islamabad was conducted in a cross-sectional study at National Institute of Health, Islamabad. The drug samples were confiscated by Anti Narcotics Force (ANF), Pakistan. Microbial analysis was done by estimating bioburden which revealed the presence of gram negative and positive bacteria's, fungus, Streptococcus, Staphylococcus species. Trypton soya agar was used for total aerobic count, MacConkey agar for gram-negative bacteria, Sabouraud dextrose agar for fungus and Vogel-Johnson agar for Streptococcus and Staphylococcus species...
September 2016: Pakistan Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27721009/a-shape-memory-foam-composite-with-enhanced-fluid-uptake-and-bactericidal-properties-as-a-hemostatic-agent
#20
T L Landsman, T Touchet, S M Hasan, C Smith, B Russell, J Rivera, D J Maitland, E Cosgriff-Hernandez
: Uncontrolled hemorrhage accounts for more than 30% of trauma deaths worldwide. Current hemostatic devices focus primarily on time to hemostasis, but prevention of bacterial infection is also critical for improving survival rates. In this study, we sought to improve on current devices used for hemorrhage control by combining the large volume-filling capabilities and rapid clotting of shape memory polymer (SMP) foams with the swelling capacity of hydrogels. In addition, a hydrogel composition was selected that readily complexes with elemental iodine to impart bactericidal properties to the device...
October 6, 2016: Acta Biomaterialia
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