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Safety check for sterility

Kelley M Reece, Miguel A Lozano, Ryan Roux, Susan M Spivey
PURPOSE: The implementation and evaluation of a gravimetric i.v. workflow software system in an oncology ambulatory care pharmacy are described. SUMMARY: To estimate the risk involved in the sterile i.v. compounding process, a failure modes and effects analysis (FMEA) in the oncology ambulatory care pharmacy was performed. When a volumetric-based process was used to reconstitute vials, the actual concentration was unknown since an assumption must be made that the exact volume of diluent was used when reconstituting the drug...
February 1, 2016: American Journal of Health-system Pharmacy: AJHP
Tarun K Podder, Luc Beaulieu, Barrett Caldwell, Robert A Cormack, Jostin B Crass, Adam P Dicker, Aaron Fenster, Gabor Fichtinger, Michael A Meltsner, Marinus A Moerland, Ravinder Nath, Mark J Rivard, Tim Salcudean, Danny Y Song, Bruce R Thomadsen, Yan Yu
In the last decade, there have been significant developments into integration of robots and automation tools with brachytherapy delivery systems. These systems aim to improve the current paradigm by executing higher precision and accuracy in seed placement, improving calculation of optimal seed locations, minimizing surgical trauma, and reducing radiation exposure to medical staff. Most of the applications of this technology have been in the implantation of seeds in patients with early-stage prostate cancer...
October 2014: Medical Physics
Abdo Khoury, Sylvère Hugonnot, Johan Cossus, Alban De Luca, Thibaut Desmettre, Fatimata Seydou Sall, Gilles Capellier
Manual ventilation is a vital procedure, which remains difficult to achieve for patients who require ventilatory support. It has to be performed by experienced healthcare providers that are regularly trained for the use of bag-valve-mask (BVM) in emergency situations. We will give in this paper, a historical view on manual ventilation's evolution throughout the last decades and describe the technical characteristics, advantages, and hazards of the main devices currently found in the market. Artificial ventilation has developed progressively and research is still going on to improve the actual devices used...
2014: BioMed Research International
Justin L Hawkins
Failure of components integrated into the cardiopulmonary bypass circuit, although rare, can bring about catastrophic results. One of these components is the heat exchanger of the membrane oxygenator. In this compartment, unsterile water from the heater cooler device is separated from the sterile blood by stainless steel, aluminum, or by polyurethane. These areas are glued or welded to keep the two compartments separate, maintaining sterility of the blood. Although quality control testing is performed by the manufacturer at the factory level, transport presents the real possibility for damage...
March 2014: Journal of Extra-corporeal Technology
L Chappuy, C Charroin, F Vételé, T Durand, T Quessada, M-C Klotz, F Pirot, V Bréant, G Aulagner
INTRODUCTION: Initially, parenteral nutrition admixtures are produced by sterile filtration with a stability of 14 days This study was conducted to check the stability (physicochemical and microbiological) when automated compounding BAXA(®) EM 2400 is used. MATERIALS AND METHODS: Forty pockets corresponding to 10 patients have been manufactured in according to Good Manufacturing Practice. Macroscopic and physicochemical tests (determination of electrolytes by atomic absorption spectroscopy, osmolality and pH measurements) were performed at different times (D0, D7, D14)...
November 2013: Annales Pharmaceutiques Françaises
Marian Robinson
Recognizing the importance of documenting pharmacy activities to ensure both standardized practice and dose safety, a number of software products have been introduced to support sterile compounding activities. Among these, technology for managing pharmacy workflow is intended to ensure best practice for dose preparation and tracking; and support critical pharmacist's dose checking and verification activities. This guide is intended to help pharmacists through the process of selecting technology, with the aim of matching that technology to the operational, management, and financial needs of their pharmacy organizations...
January 2011: International Journal of Pharmaceutical Compounding
Mark W Mackay, Jared Cash, Fred Farr, Marc Holley, Kevin Jones, Sabrina Boehme
BACKGROUND: Standardization is an invaluable tool to promote safety, improve care, and decrease costs, which ultimately improves outcomes. However, a pediatric setting presents unique challenges with its wide variety of weights, medications, and needs that are distinctly different. Our goal was to develop and implement standards in complex high risk areas that show improved outcomes and safety. PROGRAM DESCRIPTION: A computerized prescriber order entry program with decision support for pediatrics was developed for parenteral nutrition prescribing...
October 2009: Journal of Pediatric Pharmacology and Therapeutics: JPPT: the Official Journal of PPAG
Leanne Jones, Mohammad Othman, Therese Dowswell, Zarko Alfirevic, Simon Gates, Mary Newburn, Susan Jordan, Tina Lavender, James P Neilson
BACKGROUND: The pain that women experience during labour is affected by multiple physiological and psychosocial factors and its intensity can vary greatly.  Most women in labour require pain relief. Pain management strategies include non-pharmacological interventions (that aim to help women cope with pain in labour) and pharmacological interventions (that aim to relieve the pain of labour). OBJECTIVES: To summarise the evidence from Cochrane systematic reviews on the efficacy and safety of non-pharmacological and pharmacological interventions to manage pain in labour...
2012: Cochrane Database of Systematic Reviews
Mayank K Mittal, Jon B Morris, Rachel R Kelz
INTRODUCTION: Medical student procedural training has become increasingly limited amid concerns for patient safety. Because simulation education has been shown to be effective for early skills training, we used germ simulation for teaching hand hygiene principles and aseptic technique in urinary catheterization (UC). We hypothesized that posttraining, students would demonstrate proficiency comparable to surgery residents. METHODS: Seventy-five clinical clerks, second-year medical students, underwent the simulation training...
April 2011: Simulation in Healthcare: Journal of the Society for Simulation in Healthcare
Diane B Kimsey
Lean production is a process management philosophy that examines organizational processes from a customer perspective with the goal of limiting the use of resources to those processes that create value for the end customer. Lean manufacturing emphasizes increasing efficiency, decreasing waste, and using methods to decide what matters rather than accepting preexisting practices. A rapid improvement team at Lehigh Valley Health Network, Allentown, Pennsylvania, implemented a plan, do, check, act cycle to determine problems in the central sterile processing department, test solutions, and document improved processes...
July 2010: AORN Journal
Susan Pirie
An essential component of any clinical intervention or clinically invasive procedure in the perioperative setting will involve the use of instruments. It is therefore essential that all practitioners in the perioperative setting are able to identify the instruments required for a case, for both preparation and checking purposes, be able to verify the sterility of the instrument and/or set, and be aware of the actions to be taken if any problems arise.
January 2010: Journal of Perioperative Practice
Ronald Moy, Corey Maas, Gary Monheit, M Barbara Huber
OBJECTIVE: To evaluate the long-term safety of repeated administrations of a new botulinum toxin type A (Reloxin; Medicis Pharmaceutical Corp, Scottsdale, Arizona) in the treatment of moderate to severe glabellar lines. METHODS: Open-label assessment of 1200 patients receiving as many as 5 treatments of Reloxin over a 13-month period. The product was diluted in 2.5-mL sterile physiologic saline solution, 0.9%, without preservative to a concentration of 50 U of Reloxin per 0...
March 2009: Archives of Facial Plastic Surgery
Diane Gilmour
Surgical instruments, whether single use or reusable, are defined by the University of Newcastle's Online Medical Dictionary as 'Hand held tools or implements used by health professionals for the performance of surgical tasks' (CancerWEB 1998). This definition, in its broadest terms, recognises that the inter-professional team (health professionals) are involved in the use, care and management of that tool or implement (performance of surgical tasks). Spry (2007) identifies that a surgical instrument could last 10 years if well made, carefully handled and appropriately used and that it is the responsibility of the surgical team and sterile services personnel to preserve and protect the life of each individual instrument...
July 2008: Journal of Perioperative Practice
J D Stopforth, B Kottapalli, M Samadpour
Manual dispensing equipment for aseptically packaged beverages or foods requires refrigeration of the product package following breakage of the hermetic seal. The food service industry would benefit greatly by implementing dispensing equipment that maintains the sterility of products after continued use without the need for refrigeration. The purpose of this study was to evaluate the ability of a valve, designed to operate aseptically and dispense products with or without refrigeration, to maintain the sterility of products following breakage of the hermetic seal and continued use simulating that of food service...
March 2008: Journal of Food Protection
Rita Singh, Sumita Purohit, M P Chacharkar, P S Bhandari, A S Bath
Amniotic membranes collected from the placentae of screened donors were processed and sterilized by gamma irradiation at 25 kGy. The sterility assurance level (SAL) of gamma irradiated amniotic membranes and clinical efficacy in second-degree burn wound healing were evaluated. Processed air-dried amniotic tissue from 159 batches of processing was checked for the bioburden level before sterilization. About 39% of the tissues had bioburden in the range of 10(1)-10(2)/100 cm(2) and 54.8% in the range of 10(2)-10(3)/100 cm(2)...
June 2007: Burns: Journal of the International Society for Burn Injuries
Gijs A Kleter, Ad A C M Peijnenburg
Mitochondria of cytoplasmic male sterile crop plants contain novel, chimeric open reading frames. In addition, a number of crops carry endogenous double-stranded ribonucleic acid (dsRNA). In this study, the novel proteins encoded by these genetic components were screened for the presence of potential binding sites (epitopes) of allergy-associated IgE antibodies, as was previously done with transgenic proteins from genetically modified crops. The procedure entails the identification of stretches of at least six contiguous amino acids that are shared by novel proteins and known allergenic proteins...
September 2003: Plant Biotechnology Journal
Francesca Mazzotti, Julia Beuttler, Richard Zeller, Ulrich Fink, Stefanie Schindler, Albrecht Wendel, Thomas Hartung, Sonja von Aulock
Medical devices manufactured for implantation into humans must be free of any contamination with viable bacteria. However, remnants of dead bacteria and bacterial components alone may induce an inflammatory immune response. Pyrogen tests for such inflammatory contaminations are generally performed either by determining the content of lipopolysaccharide in rinsing solutions of batch samples by limulus amoebocyte lysate assay, by injecting the rinsing solutions into rabbits or by implanting batch samples into rabbits and measuring change of body temperature...
February 2007: Journal of Biomedical Materials Research. Part A
Mauro Seveso, Orazio Maugeri, Gianluigi Taverna, Guido Giusti, Alessandro Piccinelli, Alessio Benetti, Luisa Pasini, Pierpaolo Graziotti
UNLABELLED: Conservative renal surgery (enucleation or segmentary resection) has become the gold standard treatment for small and peripheral malignant kidney lesions or in cases of reduced renal function or bilateral lesions. The aim of this study is to evaluate the incidence and treatment of complications of this technique in our experience. MATERIALS AND METHODS: Between March 1997 and March 2005, 159 patients aged from 23 to 77 years (median 66 years) underwent conservative renal surgery...
December 2005: Archivio Italiano di Urologia, Andrologia
Peggy Edwards
Theatre practitioners have been involved in patient safety for years. Each time you check a patient into the department you are using a risk management tool: the check-list. Each time you check the position of a patient on the operating table, check their consent form, ensure the sterile field is maintained and that the instrument count is correct, you are intrinsically involved in patient safety.
October 2005: British Journal of Perioperative Nursing: the Journal of the National Association of Theatre Nurses
H Bass, R Walters, C Darke
A bank of Epstein-Barr virus (EBV)-transformed B-lymphoblastoid cell lines (BCLs) has been established in this laboratory over the last 7 years. Novel, rare and unusual HLA phenotypes were highlighted during routine clinical testing and during typing of volunteer haematopoietic stem cell donors for the Welsh Bone Marrow Donor Registry. The BCLs are routinely used as laboratory reagents, as a source of DNA for reference purposes and for research work. Consenting donors are tested for hepatitis B surface antigens (HBsAg), human immunodeficiency virus (HIV) and hepatitis C virus (HCV) before their B-lymphocytes are transformed...
April 2004: European Journal of Immunogenetics
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