Safety check for sterility

UNLABELLED: Current treatment modalities are limited in their approach and success for hair loss. QR 678 & QR 678 Neo are new formulations, consisting of a combination of growth factors and peptides. This study demonstrates safety analysis of QR 678 & QR 678 Neo formulation, using in vitro cytotoxicity assay and in vivo animal efficacy. METHODS: Factors including vascular endothelial growth factor, basic fibroblast growth factor, insulin-like growth factor-1, keratinocyte growth factor, and copper tripeptide 1 (QR 678) or their biomimetic peptides (QR678 Neo) were suspended in a sterile injectable vehicle...

Microbes are found all over the globe with some few exceptions, including sterilized surfaces. They include normal flora that is nonpathogenic, which contribute to the larger percentage, and pathogenic species which are few. Hence, the activities of humans cannot be completely separated from microbes. Thus, many pathogenic microbes have found their way into fresh fruits and vegetables which are a great source of a healthy diet for humans. The growing demand for fresh fruits and vegetables has necessitated larger production...

OBJECTIVES: To determine prospectively the risk reducing measures of non-sterility during aseptic handling and to develop a method for prioritising these measures. METHODS: In the first part of this series of articles, we identified all sources of risk which could contaminate a product during aseptic handling, and calculated the remaining risks of non-sterility using a risk assessment (RA) model. We concluded that additional research of some risk sources was needed before risk control (RC) could be executed on all risk sources...

PURPOSE: To evaluate the impact of remote sterile product pharmacist checks when used with a gravimetric-based technology-assisted workflow (TAWF) system on product checking accuracy, pharmacist review time, workload sharing, cost savings, and staff perceptions. METHODS: A double-arm, prospective study was conducted at 4 pharmacy locations for a 90-day period. Each compounded sterile product (CSP) checked by a remote pharmacist was also checked by a local pharmacist at the site of CSP preparation...

Achieving reliable instrument reprocessing requires finding the right balance among cost, productivity, and safety. However, there have been few attempts to comprehensively examine sterile processing department (SPD) work systems. We considered an SPD as an example of a socio-technical system - where people, tools, technologies, the work environment, and the organization mutually interact - and applied work systems analysis (WSA) to provide a framework for future intervention and improvement. The study was conducted at two SPD facilities at a 700-bed academic medical center servicing 56 onsite clinics, 31 operating rooms (ORs), and nine ambulatory centers...

Despite the use of sterile technique for indwelling urinary catheter insertion, as well as use of the defined catheter-associated urinary tract infection (CAUTI) bundle elements per Children's Hospitals' Solutions for Patient Safety, the CAUTI rate in the pediatric intensive care unit (PICU) at a free-standing pediatric hospital was increasing. In 2017, the PICU accounted for 87% of the organization's CAUTIs and 65% of the total indwelling catheter device days. With an important risk factor for CAUTIs being the duration of catheterization, the indication for catheters became an organizational executive priority...

BACKGROUND: This study examined whether corneas from bacteremic donors could be used for corneal transplant. METHODS: Corneas donated to the National Eye Bank of Taiwan between 1 January 2014 and 30 June 2017 were included in this study. All the corneas had corneoscleral rim cultures during the retrieval process and were hypothermic preserved in the Optisol-GS storage medium. A microbial work-up flow chart was used for the sterility check of all grafts. Bacteremic donors were defined as those whose last blood culture before corneal donation was positive...

PURPOSE: The impact of a gravimetric-based technology-assisted workflow (TAWF) system on hazardous compounded sterile product (CSP) production time, staff perception of safety, and job satisfaction was evaluated. METHODS: For 2 weeks before implementation of a gravimetric-based TAWF, staff utilized an automated punch clock to document the time to prepare and check CSPs compounded volumetrically. Simultaneously, an anonymous, online survey was e-mailed to staff to evaluate their perceptions regarding the safety of volumetric preparation and satisfaction with their role preparing CSPs...

The quality of medicines in some developing countries including Pakistan is not very satisfactory regarding safety and efficacy. In addition to sterile preparations, the microbial contamination of non sterile preparations should also be monitored according to USP microbial limits for these preparations. This study was designed to check the microbial quality of some commonly used non-sterile preparations available in Pakistan. Total 133 samples containing national and multinational brands of different dosage forms were collected from retail setups of Sargodha, Khushab and Chakwal cities...

OBJECTIVE: To explore the feasibility, safety, and preliminary technical experience of single incision plus one port laparoscopic total gastrectomy combined with π-shaped esophagojejunal anastomosis (SILT-π) in the surgical treatment of gastric cancer. METHODS: Clinical data of 5 gastric cancer patients undergoing SILT-π operation at the Department of General Surgery, The Second Affiliated Hospital of the Army Medical University from August to October 2017 were retrospectively analyzed...

OBJECTIVE: To evaluate the feasibility and the short-term safety of self-pulling and latter transected esophagojejunostomy(SPLT) in totally laparoscopic total gastrectomy (TLTG). METHODS: One hundred patients with gastric cancer received TLTG-SPLT at General Surgery Department of Huashan Hospital (Fudan University) from June 2014 to January 2017(SPLT group). The clinicopathologic characteristics, surgical and postoperative outcomes were collected retrospectively and compared with the conventional group undergoing TLTG plus overlap or functional end-to-end anastomosis from October 2013 to December 2015...

Background: USP <797> regulatory requirements have mandated that pharmacies improve aseptic techniques and cleanliness of the medication preparation areas. In addition, the Institute for Safe Medication Practices (ISMP) recommends that technology and automation be used as much as possible for preparing and verifying compounded sterile products. Objective: To determine the benefits associated with the implementation of the workflow management system, such as reducing medication preparation and delivery errors, reducing quantity and frequency of medication errors, avoiding costs, and enhancing the organization's decision to move toward positive patient identification (PPID)...

Despite significant advances in HIV drug treatment regimens, which grant near-normal life expectancies to infected individuals who have good virological control, HIV infection itself remains incurable. In recent years, novel gene- and cell-based therapies have gained increasing attention due to their potential to provide a functional or even sterilizing cure for HIV infection with a one-shot treatment. A functional cure would keep the infection in check and prevent progression to AIDS, while a sterilizing cure would eradicate all HIV viruses from the patient...

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...

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...

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...

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...

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)...

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...

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...