The risk management of a product does not end once a product is on the market -- in fact, it becomes more rigorous. The work that Medical Safety does in post market surveillance and vigilance are integral in ensuring marketed products perform as intended and do not harm patients. ISO 14971 provides guidance on what should be included in a post-market monitoring process:
• Determination if changes must be made to the original medical device risk assessment;
• A systematic process to evaluate product (not just customer complaints);
• Inclusion of objective evidence in the risk management file;
• Evaluation of any new hazards;
• Determining whether there have been changes in the acceptability of risks as originally defined; and
• Inclusion of
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The information gathered provides insight to what product was involved, where the event occur, what harm resulted from the event, the severity of the harm, what treatment was given, and what outcome resulted.
The challenge of post market complaint data is the variability of information received. Some reporters provide detailed information on the complaint and treatment (e.g., a central 1mm corneal ulcer with negative cultures treated with Vigamox® every hour in affected eye) while other complaints may be vague (e.g., eye pain). Medical Safety is tasked with case follow up to ensure all pertinent information is gathered. The timeliness of complaint report processing and the quality and accuracy of complaint reports are critical in the analysis of post market
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To ensure consistency of medical assessments, Medical Safety decides and establishes the criteria of a complaint. This is needed because there are varying treatment and risk profiles within a medical diagnosis. For example, a report of Endophthalmitis is a serious event. However, how is the severity of a bacterial infection established? A bacterial infection of the central cornea with a positive culture for pseudomonas has a higher severity than a bacterial infection of the conjunctiva with no corneal involvement. By having a criterion, Medical Safety accurately and consistently classifies complaints. The criterion helps with the assessment of cases with limited information. For example, reports of “chemical burn” would be considered more serious than a report of “irritation”. By establishing an adverse event reporting criteria, Medical Safety effectively assesses complaints in a consistent fashion. This increases the reliability of complaint trending and analysis and helps Medical Safety to monitor a products safety profile.
At set time intervals, Medical Safety compares post market complaints and sales to identify trends in complaint reporting and unexpected product event combinations. Medical Safety does this by using statistical and descriptive analysis. Three examples of signaling and trending methods that can be used include: Empirical Bayes Geometric Mean (EBGM), U-Chart,
middle of paper ... ... Root Cause Analysis in Response to a Sentinel Event. Retrieved on March 2014 from world wide web at http://www.pedsanesthesia.org/meetings/2004winter/pdfs/heitmiller_Sentinel.pdf Orlando Regional Healthcare, Education & Development. (2004). Patient Safety: Preventing Medical Errors.
The Institute of Medicine (IOM) reported in 1999 that between 44,000 and 98,000 people die each year in the United States due to a preventable medical error. A report written by the National Quality Forum (NQF) found that over a decade after the IOM report the prevalence of medical errors remains very high (2010). In fact a study done by the Hearst Corporation found that the number of deaths due to medical error and post surgical infections has increased since the IOM first highlighted the problem and recommended actions to reduce the number of events (Dyess, 2009).
Health is an ever growing and developing sector. Newer diseases raise their head from time to time. These developments put new challenges for mankind. To meet the challenges put forward by the diseases and their outcomes; there is a need for scientific and strategic innovations. These innovative measures empower the healthcare sector to fight the disease and overcome the disease burden. Australian commission on safety and quality in healthcare is also one such innovative step that aims at provision of a universal healthcare service to all across Australia.
There are a few types of medical errors discussed in Patient Safety Principles & Practice. One of them is an error of execution. An error of execution is when a correct action does not proceed as intended. It is a failure of a planned action to be completed as first intended. It occurs unintentionally during an automatic performance of patient care. This error is almost always observable at the patient and caregiver interface.
Direct legal issues that result in inadequate infection-control practices, medical costs of healthcare-associated infections and the amount of deaths that have occurred due to these preventable infections are the main targeted issues that will focus on this project. Reporting requirements of HAIs vary from state to state, provider, facility, frequency, and type of infection. Due to this, there is inconsistency in the methods of data collected, risk management, data validation, and the requirement or reporting HAIs. The legal requirements and statutes that mandate disclosure of errors need to be addressed in order to reduce and prevent HAIs. In addition, the discussion of legal duties and responsibilities of the care providers, facilities and patients are discussed.
The purpose of this paper is to identify a quality safety issue. I will summarize the impact that this issue has on health care delivery. In addition, I will identify quality improvement strategies. Finally, I will share a plan to effectively implement this quality improvement strategy.
Safety is a primary concern in the health care environment, but there are still many preventable errors that occur. In fact, a study from ProPublica in 2013 found that between 210,000 and 440,000 patients each year suffer preventable harm in the hospital (Allen, 2013). Safety in the healthcare environment is not only keeping the patient safe, but also the employee. If a nurse does not follow procedure, they could bring harm to themselves, the patient, or both. Although it seems like such a simple topic with a simple solution, there are several components to what safety really entails. Health care professionals must always be cautious to prevent any mishaps to their patients, especially when using machines or lifting objects, as it has a higher
Working as a nurse, patient care associate, or any other health care professional is not an easy job. Nursing profession has the highest rate of back and other injuries related to lifting, moving and transporting patients. Hospitals and other nursing facilities were experiencing increased numbers of injuries, which meant many lost work days, worker’s compensation costs and patient safety at risk.
risk, for drugs and medical devices, weighing risks against benefits is at the core of
...occurrences including sentinel events, near misses and serious occurrences; Detail of program activities that the high-risk process components; Results of the high-risk or error-prone processes selected for ongoing measurement and analysis; results of input from patients and families participation in improving patient safety is obtained; report medical/health care errors description of education and training programs that are maintaining and improving employee proficiency and supporting approach to patient care (Ihi.org,2011).
The National Patient Safety Goals are a key when it comes to patient safety. Implementing safety goals helps reduce the number of medication errors, improves communication between members of the healthcare team and reduces the number of infections patients acquire while under the hospital’s care. In addition, The Joint Commission reviews and publishes these goals each year. Depending on the occurrence of sentinel events, the goals are re-evaluated or revised accordingly. It is important that The Joint Commission reinforce the practice of patient safety goals in that they help improve patient care.
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...
It is shocking to know that every year 98000 patients die from medical errors that can be prevented(Kohn, L. T., Corrigan, J. M., & Donaldson, M. S. (Eds.), 2000). Medical errors are not a new issue in our healthcare system; these have been around for a long time. Hospitals have been trying to improve quality care and patients safety by implementing different strategies to prevent and reduce medical errors for past thirty years. Medical errors are the third leading cause of death after heart disease and cancer in America (Allen, 2013). In addition medical errors are costing our healthcare system an estimated $735 billion to $980 billion (Andel, Davidow, Hollander, & Moreno, 2012).
Meeting the needs and expectations of those providing health care encourages and able to recognize and report adverse events and prepare through training and education to partake in open disclosure.
It’s true what everyone talks about safety – you are the key to your safety, when you do it safely you do it the right way and the best gift you can give to your family is to always stay safe. We have been taught by our parents and teachers to be cautious while doing a number of things. That’s very essential in our daily lives, because one needs to be extra cautious to prevent unavoidable accidents. However, mishaps do happen everywhere in the safest of places, no matter how careful we are in our actions. It is highly unpredictable, what’s going to happen the very next instant. There are numerous incidences we come across like simple trips, falls, cuts due to sharp objects, burns or sudden worsening of a person’s health condition, causing