In a study of Franz (2014), Pal (2013) found that an artificial heart valve is a gadget fixed in a heart of a patient suffering from valvular heart ailment. Malfunctioning of any of the four natural heart valves necessitates organ implant. Turning to Pal (2013,) one finds that stents resemble a mesh tube used in the treatment of weak blood vessels. The research paper will study the technology employed in making the two devices and then analyze the product vulnerabilities, potential internal and external threats, levels of security to secure the gadgets and finally describe the risk management practices regarding the products and the related technology.
Analysis of system vulnerabilities
The work of Franz (2014) shows that the artificial heart valves are prone to hardening over several years hence exposing the patient to great risk. Franz (2014) explains that in the state told the pipes are vulnerable to failing. A growing body of research has proven that that previous cases of valve hardening resulted in failure. According to Rejda (2008), hardening of the prosthetic valves carries a high likelihood of mortality. Hardening happens as a result of gradual deterioration of valve function ending creating a need to perform the second replacement. Reference to Rejda (2008) reveals that the occurrence happens within a period of five to fifteen years after the first prosthesis implant. Reoperation to correct hardening puts a patient at a greater risk of death.
Tissue failure
The work of Rejda (2008) shows that the device-tissue can fail if a patient lives longer, surpassing the life span of the prosthetic fabric. Medical doctors' from Harvard School of Medicine explain that the gadget's tissue has a limited number of years. The period in most patients ranges from 5-15 years. Occurrence prompts reoperation exposing the patient to additional risks of pain and inconveniences (Pal, 2013).
Pannus(tissue ingrowth)
Pal (2013) perceptively states that the two gadgets are vulnerable to an in growth resulting from the production of a fibrous scar tissue by the body. The anomaly occurs at the site of the implant after removal of the native valve. The dysfunctional happening can result to valve thrombosis necessitating urgent operation.
Stuck leaflets (impingement)
Pal (2013) has drawn attention to the fact that likelihood exists whereby the leaflets in the mechanical prosthesis get trapped by blood pressure on the valve orifice. The tissues underneath the valve would most likely cause the leaflets to stick resulting in an impingement (Rejda, 2008). The scenario puts patient implanted organs at the risk of valve failure.
Nature of internal and external threats jeopardizing the products
Thromboembolic complications
Doctors categorize the anomaly as one of the biggest challenges designers face in developing the two artificial organs (Rejda, 2008). The occurrence of the phenomena can jeopardize standard functionality of the device posing a significant health risk to the patient.
Bactria infection
The phenomenon is an external threat to the functioning of the heart valve and the stent. The bacteria gain access to the site of the implant via the blood stream causing an infection. According to Rejda (2008), intravenous drug use, as well as a mistake during surgery, can cause an infection.
Prolapsed mitral valve
Pal (2013) makes clear that MVP is a condition that results when the leaflets of the artificial valve fail to meet properly. The primary cause of the dysfunctional occurrence is too lengthy chordae tendineae. Rejda (2008) postulates that either of the two leaflets becomes enlarged and this may result in an abnormal noise from the heart. Failure of the two leaflets to touch each other would lead in leaking of blood from the left ventricle to the left auricle causing heart murmur (Rejda, 2008).
Pulmonary valve incompetence
The work of Franz (2014) asserts that the condition results from an abnormally high pressure in the arteries or veins. The pulmonary blood vessels or with aortic valves might develop a problem causing pulmonary valve leakage. The threat may jeopardize the functioning of either of the device causing dilation of the pulmonary valve.
In an article by Franz (2014), other threats that may expose the proper operation of the systems to jeopardy include mechanisms such as forward and backward flow shear, cellular maceration, the presence of foreign material such as coagulation cascade and static leakage shear. Furthermore, other internal and external occurrences threatening the operation of the devices include valve tissue interaction, potential wear, blockage as a result of a clot, getting stuck, dynamic responsiveness as well as safety failure. Franz (2014) observes that valve orifice to anatomical ratio, blood leakages, detachable and replaceable Models of heart valves as well as transvalvular pressure gradient can potential hamper correct functioning of heart valves and stents. Wearing out of stent may result to tissue heart valve failure disturbing normal valve activities.
Levels of security
Pal (2013) reports that taking anticoagulants acts as a protection to prevent the occurrence of anomalies that may jeopardize the correct functioning of the system. Taking blood thinner would assist in protecting an individual from blood clot occurrence. Pal (2013) argues that conventional anticoagulants such Coumadin act as security against forming of fatal blood clots. Rejda (2008) discovered that the anticoagulants drugs interfere with potential blood clot sequence rapidly increasing the time a lump would take to form. The scenario gives blood and other body fluids to wash away any blood clumps creating a small percentage likelihood of clot formation Moreover, undergoing aortic valve replacement would act as a caution to prevent the occurrence of abnormal valve and stent conditions (Rejda, 2008).
The operation leads to removal of pulmonary valve to replace the aortic valve.The case explains that hiring prestigious qualified medical personnel would act as security against the occurrence of the described abnormalities. The competency possessed by the practitioners would help come up with more innovative ways as well as organ parts to prevent problems such as tissue failing, wearing out and blood clots. The opinion of Rejda (2008)is that the medical personnel would discover new ways of fixing the organs and use of proper medication after surgery to avoid complications. The text highlights possible ways of increasing product security for example of drugs such as Beta blockers, ACE inhibitors to control blood pressure.Rejda (2008)states that increase in pressure before healing would result to stent tearing causing further complications. Moreover, use of drugs such as statins would lower levels of cholesterol, thereby helping avoid thickening of inner linings of the blood vessels that would result in high pressure ultimately affecting stents and the artificial valves (Rejda, 2008).
Principles of risk management
Organization context
According to Pal (2013) Riordan Manufacturing Virtual Organization undertaking of making artificial valves and stents can be affected by political-legal, technological and societal, changes. Technology advancement would impact the organization positively. The change would result in the innovation of new and improved ways of making more durable and efficient health devices (Pal, 2013). Political reforms may affect the organization positively and negatively depending upon nature of new regulations. The manager in the organization should ensure changes in either field add value to the organization process.
Stakeholder’s involvement
Pal (2013) asserts the importance of engaging all stakeholders in the decision-making process. The parties should jointly decide the appropriate technology to apply when developing the valves and the stents. Pal (2013) argues that involving the individuals would help in making informed decisions towards enhancing the efficiency of the organization technology.
Organizational objectives
Rejda (2008) notes that it is imperative to align organizational goals with risk management approaches a company embraces. The goal to excel in nerve and stent technology should address any uncertainties such as technology failure and obsolescence (Rejda, 2008). The owner should be systematic and adopt a structured way of technological as well as organizational development.
Reporting
Rejda (2008) observes that reporting is vital to risk management. The organization leaders should ascertain the genuineness of organization information, for example, data available on technology development in the given group. Upholding transparency and visibility promotes actionable risk management undertaking.
Roles and responsibilities
According to Rejda (2008), the process of planning risk management to cover the products in the organization should be transparent and engage parties across the board. The medical practitioners should know the particular roles assigned to each in every stage of risk management. The individuals should understand the responsibilities in every phase of product development.
Progressive improvement
The organization should continually improve the risk management strategies that cover both product and the technology applied (Pal, 2013). Application of continuous learning would help manage ongoing risk for the current technological applications in the organization.
References
Franz, T. (2014). Cardiovascular and cardiac therapeutic devices. N.p
Pal, S. (2013). Design of artificial human joints & organs. N.p
Rejda, G. E. (2008). Principles of risk management and insurance. Boston: Pearson/Addison Wesley.
