Sterile compounding is the preparation of products that should be free from all viable forms of life. There are more stringent requirements for sterile compounding than there are for non-sterile compounding. Staff must be trained and tested on their aseptic processing abilities, cleaner aseptic facilities are required, the quality of air entering the aseptic facility must be evaluated and maintained, sterilisation processes must be effective, knowledge of solution stability is needed and sterility testing of the products is required. The most common type of compounded sterile preparations (CSP) used clinically are aqueous injections. These CSPs require greater attention when being prepared as they pose the greatest risk to the patient if they …show more content…
There are several conditions which aid in defining a CSP as high risk level: when non-sterile ingredients are used in the preparation or when a non-sterile device is used before sterilisation; when the preparation is exposed to air which is not of sufficient quality (less than ISO class 5) e.g. when a manufactured sterile product that lacks a preservative is exposed to air in storage it would be classified as high risk; if a non-sterile product is exposed for at least six hours before being sterilised. Before administration to a patient, the CSP cannot be exposed for not more than 24 hours at a controlled room temperature, no more than 3 days at a cold temperature and no longer than 45 days in freezing conditions (-20°C or less). All non-sterile equipment being used in high risk level compounding must be is rinsed with pyrogen free sterile water and drained or dried directly right before compounding begins. CSPs which are subject to terminal moist heat sterilisation are to be filtered before or during transfer into their final container through a filter with a nominal pore size of no greater than 1.2µm. Sterilisation by filtration must be undertaken in an environment of ISO class 5 or greater. Some examples of high risk level compounding processes include dissolving non-sterile bulk ingredients to produce solutions which are to be terminally sterilised, or when sterile components of the CSP are mixed in non-sterile containers prior to sterilisation. Quality assurance tests must be undertaken to verify the quality of the compounding process. The procedures for such tasks are the same as for low risk level compounding assessment except that a media fill test which accurately simulates the most stressful conditions associated with high risk level compounding is done by personnel twice a
Comment on class result with respect to differences in filter types, differences in filter assemblies, and overall on the confidence you would have in using this type of sterilisation process in preparation of pharmaceutical products. List the factors that may cause contamination during filtration. (20 marks)
This essay describes how the anaesthetic machine and airway management equipment are prepared in operating theatres and discusses how they are ensured safe for use. It evaluates the Association of Anaesthetists of Great Britain and Ireland (AAGBI) guidelines related to safe practice and the preparation of the ET tubes, laryngeal masks, guedels, Naso pharyngeal airways and the laryngoscope. The function of the anaesthetic workstation is to deliver a mixture of anaesthetic agents and gases safely to the patient during the induction process and throughout surgery. In addition, it also provides ventilation to support breathing and monitors the patient’s vital signs to minimise the anaesthetic risks to the patient whilst in the care of health professionals. The pre-use check is vital to patient safety as an inadequate check of the anaesthetic machine or airway management equipment can and does lead to significant harm of the patient including mortality (Medicines and Healthcare Products Regulatory Agency (MHRA), 2008 and Magee, 2012).
STERILIZATION Competent SPD (sterile processing department) technicians must be knowledgeable about all available sterilization methods, regardless of whether those methods are currently being used at their facility. The sterilization equipment, sterilization parameters, and loading and unloading of sterilizers are all critical components of effective sterilization .in addition, sterilization processes must be monitored administratively, biologically, and chemically. It is important that all
Yacopetti, N., Davidson, P., Blacka, J., & Spencer, T. (2013). Preventing contamination at the time of central venous catheter insertion: a literature review and recommendations for clinical practice. Journal Of Clinical Nursing, 22(5/6), 611-620. doi:10.1111/j.1365-2702.2012.04340.x
Precision of a patient’s intravenous medication is essential; it must be safe from. contamination, toxicity, and side effects. Most people believe these medications are compounded or mixed by a trained and licensed individual. However, this is inaccurate because the pharmacy technician actually compounds a large percentage of a patient’s medications. Compounding involves a technician’s math skills, aseptic technique, and professional ethics.... ...
Bowers, L., Allan, T., Simpson, A., Nijman, H., & Warren, J. (2007). Adverse Incidents, Patient
...e of bacterial contamination of raw materials subject to environmental pollution, sterilization is not complete, improper storage methods and unsanitary operations.
The patient was identified and the procedure was explained preliminary to administering the injection, to ensure the patient fully understood the procedure and to gain consent from them. The possible side effects of the medication were outlined aswell. ...
The Joint Commission was founded in 1951 with the goal to provided safer and better care to all. Since that day it has become acknowledged as the leader in developing the highest standards for quality and safety in the delivery of health care, and evaluating organization performance (The Joint Commission(a) [TJC], 2014). The Joint Commission continues to investigate ways to better patient care. In 2003 the first set of National Patient Safety Goals (NPSGs) went into effect. This list of goals was designed by a group of nurses, physicians, pharmacists, risk managers, clinical engineers, and other professionals with hands-on experience in addressing patient safety issues in a wide variety of healthcare settings (TJC(b), 2014). The NPSGs were created to address specific areas of concern in patient safety in all health care settings.
The Merck Manuals. (2008). The Merck Manuals. Retrieved from The Merck Manuals Online Medical Library: http://www.merckmanuals.com/home/ag/sec07/ch107/ch107b.html
To continue, compounding would be needed if a patient wants to change something about the medicine such as flavor or strength. It is vital that s...
Safety is focused on reducing the chance of harm to staff and patients. The 2016 National Patient Safety Goals for Hospitals includes criteria such as using two forms of identification when caring for a patient to ensure the right patient is being treated, proper hand washing techniques to prevent nosocomial infections and reporting critical information promptly (Joint Commission, 2015). It is important that nurses follow standards and protocols intending to patients to decrease adverse
Patient safety must be the first priority in the health care system, and it is widely accepta-ble that unnecessary harm to a patient must be controlled.Two million babies and mother die due to preventable medical errors annually worldwide due to pregnancy related complications and there is worldwide increase in nosocomial infections, which is almost equal to 5-10% of total admissions occurring in the hospitals. (WHO Patient Safety Research, 2009). Total 1.4 million patients are victims of hospital-acquired infection. (WHO Patient Safety Research, 2009). Unsafe infection practice leads to 1.3 million death word wide and loss of 26 millions of life while ad-verse drug events are increasing in health care and 10% of total admitted patients are facing ad-verse drug events. (WHO Patient Safety Re...
In the event that you think you have a contamination, contact your essential consideration supplier
Despite the efforts to provide the best care, there are still different factors that may contribute to medication errors and they are the major cause of morbidity and mortality in the hospital setting. For instance, health care professionals, particularly nurses, use a broad variety of devices to help administer medications: infusion pumps, IV administration sets, oral syringes, etc. Infusion pumps are a common type of error identified in the hospitals and can cause serious harm, including death. Most of the errors are associated with