What are the basic medical reporting requirements, policies, and procedures imposed by FDA on hospitals along the following?

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Integrating theory and research needs assessment

The Safety Medical Devices Act of 1990 was enacted by Congress to
increase the amount of information the Federal Drug Administration (FDA) and
suppliers receive from users on malfunctions, adverse events, and critical
problems with medical devices. Despite the regulation enacted, studies show
that there has been widespread underreporting of such events. FDA reports
explicitly noted that less than 1{0e601fc7fe3603dc36f9ca2f49ef4cd268b5950ef1bbcf1f795cc00e94cdd119} of device problems occurring in hospitals
have been brought to their attention.

It was further
found that the more serious the problem with the device, the less likely that
it is reported. This indicates a large number of hospitals and other medical
units have been advertently withholding such very significant information to
proper government authorities. This could have been made because of fears that
their hospitals may suffer the consequences, but to the detriment of the
patients and the public.

The effects of
withholding critical information will have adverse effects in the short and
long terms. Suppliers may continue producing and gaining profits out of
products and services that have been causing death and injuries to innocent
people.Hospitals with sub-standard
medical devices handled and operated by medical personnel and practitioners
with sub-standard knowledge, skills, and competencies would continue to exist
and gain profit, but at the same time continue destroying the lives and quality
of family life of many.

Medical errors,
also called “adverse events,” include missed and delayed diagnoses, mistakes
during treatment, medication mistakes, delayed reporting of results,
miscommunications during transfers and transitions in care, inadequate
postoperative care, and mistaken identity. Patient safety also encompasses the
concept of “reliability.” Reliability in health care is defined as patients
getting the intended tests, medications, information, and procedures at the
appropriate time and in accordance with their values and preferences.
System-derived errors can occur when clinicians are tired after working long
hours, stressed or cutting corners because they are in a hurry. Environmental
factors like noise and lighting can distract clinicians. Mistakes also can be
made because of a lack of standardized equipment and practices. For example, it
is easy to understand how a patient can be administered the wrong medication if
two different medicine vials look the same and the doctor is in a hurry when
grabbing a medication. Providing clearly labeled, color-coded bottles or
storing similar-looking vials in separate locations can help prevent mistakes
like these from recurring (Patrick et al, 2008).

Research problem

This research
project intends to determine the degree of compliance of the Patton – Fuller Community
Hospital with the Safe
Medical Devices and policies and procedures in ensuring the safety of medical
devices used.

The
research questions are

1.What are the basic
medical reporting requirements, policies, and procedures imposed by FDA on
hospitals along the following?

Suspected medical device –related deaths

Medical device – related serious injuries

Other medical device-related adverse events

2.What have been the
experiences of the hospital/s in relation to: suspected medical device-related
deaths, medical device –related injuries, and other medical device-related
adverse events, and how were these addressed?

3.How may the
existing adverse – event reporting system of Patton – Fuller Community
Hospital be described
along the aforementioned variables (Robbins & Coulter, 2002).

4.To what extent has
the hospital been complying to the policies and procedures imposed by the FDA
in accordance with:

1Medical Device Act
of 1990,

2Medical devices
amendments of 1992, and

3State-specific
requirements?

5.How may the
findings be used by FDA in further reviewing its Safe Medical Devices Act and
in further improving the effectiveness of the implementation of the
corresponding policies, procedures, and processes?

Hypothesis

1.There is a
significant difference between the degree of compliance to Medical Device
Reporting imposed by FDA and the extent of compliance of hospitals,
particularly, Patton – Fuller
Community Hospital.

Significance
of the study

1.Protect Patients
and families. The results of the study may help the hospital to improve its
services and be careful in the use of its medical devices.

2.Benefit hospital
management and administration. This study would reveal some loopholes in their
operations, particularly in the implementation of policies and procedures in
relation to the use of their medical devices.

3.Benefit medical
device suppliers. The adverse discovered through this study will be important
feedback that would be used in further improving the products

4.Benefit the
government. This research could help the government in monitoring and
evaluating the implementation of the Safe Medical Devices Act of 1990,
including its amendments.

What’s a Disaster? What’s a Crisis?

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Write 1-2 pages single spaced that addresses the following topic….Risk = The probability of Threat x vulnerability to that threat x consequences or loss of value of the asset. However, Risk is rarely isolated. Comment on the approach in (Griener. 2000) and top down versus bottom up risk analysis….
Here is the lecture:
Commentary
What’s a Disaster? What’s a Crisis?
Terminology is not completely standardized, so this will complicate your reading for this course. Lindell, Prater, and Perry define the terms hazard, emergency, and disaster at the beginning of Chapter 1. FEMA uses similar definitions (e.g., in the Comprehensive Preparedness Guide [CPG] 101), but the definitions are a bit different in ASIS International’s 2009 national standard and other publications. In the field of information technology, incidents are actions that violate or threaten to violate security policies, while disasters overwhelm an organization’s ability to handle the event and typically require moving essential functions to an alternate location.
A crisis generally poses a strategic threat that requires attention from and involvement of the highest levels of an organization. The impact can be to the organization’s people, mission, its financial stability, or its reputation and credibility. Like disasters, crises typically imply single, sudden, large events, but they have secondary meanings that denote a state of affairs — something that has duration. The onset may also be preceded by smaller events or incidents, by the growth of a condition, or the compounding of inter-related failures. Using an analogy from medicine, think of small strokes preceding a large stroke or the buildup of plaque in arteries leading to a heart attack. These would be termed “slow-onset” crises.
Risks to Assets
The assets of an organization include people, intellectual property (both information/data and processes), facilities, equipment, and other physical components. ASIS identifies these assets at risk: “Human Resources and Intellectual Assets; Information/Data; Facilities and Premises; Ethics and Reputation; Transportation, Distribution, and Supply Chain; Environmental, Health, and Safety; Financial Assets; … Vendor/Outsourcing” (2008, p. 5). ASIS also identifies legal and regulatory risks to organizations.
For a community, assets encompass households, businesses (for-profit and not-for-profit), government agencies, infrastructure, and even special features, such as a waterfront. The assets need to be assigned a value, even if it is a ranking such as High, Moderate, and Low.
The diagram in the attached file presents the concepts that make up risk to assets. Here, too, the terminology can vary. For example:
• Threat, hazard
• Vulnerability, exposure, weakness
• Countermeasure, safeguard, control
• Consequence, impact, harm
One term missing from the diagram is the likelihood of the threat exploiting the vulnerability. And likelihood may be characterized in terms of probability or frequency. The following sections explore threats, vulnerabilities, controls, consequences, and likelihood.
For other terms, see the Department of Homeland Security’s DHS risk lexicon (2010), which defines nearly 125 terms associated with risk management and analysis from a homeland security perspective, from “absolute risk” to “vulnerability assessment.”
Threats
Threats are a potential cause of harm to assets; they can be events, physical objects, or humans. Lindell et al. present various types of natural threats; their list could be expanded to include disease (such as pandemic flu) and infestations (such as insects, rodents, etc.). They also list technological threats, emphasizing hazardous materials. Other kinds of technological threats include structural and infrastructure failures; examples include bridges or dams, machinery, utilities, and hardware and software. The more complex a system, the more potential there is for problems, and Chiles’ book Inviting disaster: Lessons from the edge of technology (2002) provides numerous examples. Many technological threats are exacerbated by human factors such as management and operational problems; the BP oil spill in the Gulf of Mexico in 2010 is a significant example. Perrow provides a more nuanced analysis, covering not only the human factors (as in the 2009 Metrorail disaster), but also distinguishing between “integrated” and “modular” designs of complex systems (2009).
Human threats are another major category. The actions of human threat agents may be intentional or deliberate; accidental; or negligent. Intentional acts may be criminal (sabotage, espionage, terrorism, product tampering or counterfeiting, fraud) or not (e.g., boycotting the products or blockading the location of a business; hostile takeovers by another company). Accidental threats may come from errors or omissions. In a business context, accidental threats can occur because of poor procedures (they are incorrect, hard to understand, or non-existent), poor communication or bad information, poor training, or other reasons. Negligence implies that a certain standard of care or due diligence is expected. Negligence is, for example, a failure to comply with existing regulations, policies, standards, or procedures. Acts of management or of employees may be negligent, such as overriding a policy, mismanaging resources, or deception. Note that sometimes it is difficult to determine if an action is accidental or negligent. Indeed, it may not be clear at the start of some events — for example, fires — whether humans or other factors cause them.
The study of human threats also looks at whether the agent is internal to an organization (such as employees or citizens) or external. In business, the distinction between internal and external is not always exact, as there can be a continuum from inside to outside. All sorts of people may be allowed access to an organization, such as customers, contractors and vendors, third-party partners, or visitors. Ex-employees may also have access.
Insider threats may be harder to detect and insiders may cause more significant damage. Think, for example, of FBI agent Robert Hanssen who was selling information to the Russians over the course of two decades. Insider threats and incidents for the banking and financial industry were the subject of a 2004 study conducted by the U.S. Secret Service’s National Threat Assessment Center and CERT/CC. The insiders typically had “minimal technical skills” but had authorization to use the systems. However, they misused or exceeded their authorization. The National Infrastructure Advisory Council’s 2008 report describes behavioral characteristics of insiders who may pose a threat, explains why organizations fail to deal with such persons, and makes recommendations.
Speed of onset is one characteristic of a threat or hazard. Other characteristics are the scope and the duration of the impact; how predictable the event is; what the primary impacts to assets are, and whether there are secondary impacts; and the state of preparation to respond and recover. Lindell et al. present a similar list in Chapter 6, while CPG 101 lists other factors (see pp. 4-8 through 4-9). These lists were designed for physical threats, but could be adapted for cyber threats or organizational crises such as fraud, sexual harassment, or other forms of malfeasance.
Vulnerabilities
Vulnerabilities allow potential threats to cause actual events. In risk management terms, threats exploit vulnerabilities, which are weaknesses or susceptibilities to damage or disruption. Vulnerabilities may be understood as controls that are absent, weak, or flawed. (Controls are discussed in the next section.) For example,
• No fence = absent control
• Short fence = weak control
• Hole in fence or fence poorly constructed = flawed control
Some kinds of vulnerabilities are considered conditions, such as high population density for a community, the location of an organization, or the type of industry a business is in (e.g., airlines, shipping, etc.). Sometimes the distinction between threat and vulnerability becomes fuzzy around the concept of condition or circumstances. My preference is to treat circumstances and conditions as vulnerabilities that a threat agent can exploit.
Lindell et al. provide an in-depth discussion of vulnerabilities in Chapter 6, including what they call “vulnerability dynamics.” Vulnerabilities are categorized in different ways. Social vulnerabilities revolve around how well individuals, households, or other social units can deal with disasters. Physical vulnerabilities arise from design, the materials used, implementation or construction, as well as factors such as neglected or improper maintenance, all of which are influenced by costs. The same concerns apply to software in computers and other electronic devices. Geographic vulnerabilities play a role in natural disasters such as earthquakes, tornadoes, and hurricanes or, for business operations, political conditions or currency markets.
Complexity and interdependencies can obscure vulnerabilities and they can complicate efforts to respond effectively when an incident occurs, such as during the Three Mile Island nuclear reactor incident in 1979. Malfunctioning valves led to overheating of reactor coolant, causing a relief valve to open; the relief valve then did not close when it should have, and coolant drained out of the reactor. Operators, however, mistakenly believed that there was too much coolant, and drained out more coolant, leading to a meltdown of half of the reactor core (Chiles, 2002, p. 47). Perrow (2009) cites examples of airplane computers involved in accidents and near-accidents.
Controls to Mitigate (Reduce) Risk and Other Strategies
As mentioned above, one definition of vulnerability is a control that is absent, flawed or weak. The term control includes safeguards (proactive controls) and countermeasures (reactive controls). Controls mitigate risks by reducing a threat’s impacts or its likelihood, or both. Only rarely do they completely eliminate threats; that is a message that must be stated clearly (and often) to management.
One way to classify controls is whether they help to prevent (or protect or deter), detect, or respond to and recover from adverse events. Lindell et al. use the term hazard mitigation to refer to prevention controls. The levee system in New Orleans is a protection control, as are, for example, regulations about insider trading. Detection may take the form of monitoring. Examples include sensors for natural phenomena (earthquakes) or technology (pressure, temperature, traces of harmful materials, etc.). On the enterprise side, examples of monitoring might be collecting and analyzing reports of product failures or customer complaints, tracking of adherence to policies, etc. Other forms of detection include testing and quality control as well as auditing. The third area is controls for response or recovery. Here are some examples: Stockpiles of vaccines or medicines; enough trained emergency personnel; sufficient insurance or reserve funds to carry out recovery. The list is long and varied.
Consequences (Impacts)
Consequences of an adverse event are also referred to as its impacts. Some consequences are primary while others are secondary. For example, storms or flooding may have secondary consequences such as disruption of utilities or transportation.
Human impacts vary, depending on the type of crisis or disaster. Most people think first of death, injury, and illness when they discuss human impacts, but there may also be psychological and social impacts. Physical damage and destruction, whether with or without environmental consequences are created by many kinds of disasters. The consequences can disrupt vital critical infrastructures such as energy, water, communications, or transportation.
A disruption can impact an organization’s processes, the outputs of the processes, or the resources used to create the outputs, such as people, financial condition, facilities, equipment, materials and supplies. A disaster or crisis may slow or even disrupt cash flow to an organization (accounts receivable) or tourists may stay away, impacting the local economy. Responding to a crisis can also drain an organization’s or local government’s resources. There may be unplanned expenses to restore and rebuild, for example. A disaster or crisis may also result in increased insurance rates for an organization, or even being unable to obtain insurance. Primary threats to organizations’ financial assets include fraud, theft, or extortion, or negligence such as making extremely risky investments.
Other non-physical consequences may be political or legal. A crisis may draw the attention of politicians, as happened to Veterans Affairs in summer 2006 because a stolen laptop contained personally identifiable information of 26 million veterans. Regulations may be changed or added to respond to a crisis. There can be legal reactions to crises, such as government investigation and prosecution; for example, Hewlett-Packard was investigated by the California attorney general for spying on members of its board of directors and reporters to uncover leaks. Another legal reaction is filing of lawsuits. Defending against lawsuits incurs legal costs and loss of a lawsuit may require a substantial payout to the plaintiffs, such as in tobacco liability cases.

Panhandle Medical Practice

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Panhandle Medical Practice (Activity-Based Costing) Panhandle Medical Practice is a group practice owned by the area’s leading hospital, Panhandle Regional Medical
Center. The practice includes both primary care and specialty physicians, with an emphasis on internal medicine, obstetrics, pediatrics, and surgery. The practice
has three different locations, each one staffed with a mix of primary care and specialist physicians. Traditionally, ancillary services have been performed at the
hospital. Still, some ancillary services are best performed at the practice locations for one or more of the following reasons: lower costs, increased physician
efficiency, and improved patient convenience. For example, one of the practice locations now has a diagnostic imaging capability. When the scanner was moved from
the hospital to the practice location, volume increased, costs decreased, and both physician and patient satisfaction improved. The proposal now being considered
is to provide ultrasound services at the practice locations. Preliminary analysis indicates that two approaches are most suitable. Alternative 1 involves the
purchase of three ultrasound machines, one for each of the practice’s three locations. Patients would schedule appointments, generally at the location that they
are using, during preset times on particular days of the week. Then, the full-time ultrasound technician would travel from one location to another to administer
the tests as scheduled. In Alternative 2, patient scheduling would be the same, but only one ultrasound machine would be purchased. It would be mounted in a van
that the technician would drive to each of the three practice locations. Most of the operating costs of the two alternatives are identical, but Alternative 2 has
the added cost of operating the van and setting up the machine after each move. The two alternatives differ substantially in initial costs because Alternative 1
requires three ultrasound machines at a cost of $75,000 each, whereas Alternative 2 requires only one. However, Alternative 2 requires a van, which with necessary
modifications would cost $40,000. Thus, the start-up costs for Alternative 1 total 3 Af— $75,000 = $225,000, while those for Alternative 2 amount to only $75,000 +
$40,000 = $115,000. Note, though, that because the two alternatives have different operating costs, a proper cost analysis of the two alternatives must include
both initial (capital) and operating costs. The hospital’s financial staff considered several methods for estimating the operating costs of each alternative. After
much discussion, they decided that the activity-based costing (ABC) method would be best. Furthermore, an ad hoc task force was assigned the task of performing the
cost analysis. To begin the ABC analysis, the task force had to develop the activities involved in the two alternatives. This was accomplished by conducting
“walk-throughs” of the entire process from the standpoints of the patient, the ultrasound technician, and the billing and collections department. The results are
contained in Table 1. A review of the activities confirms that all except one”machine setup”are applicable to both alternatives. The next step in the ABC process
is to detail the costs associated with each activity. This step uses financial, operational, and volume data, along with the appropriate cost driver for each
activity, to estimate resource consumption. Note that traditional costing, which often focuses on department-level costs, typically first deals with direct costs
and then allocates indirect (overhead) costs proportionally according to a predetermined allocation rate. In ABC, the activities required to produce some service,
including both direct and indirect, are estimated simultaneously. For example, Table 1 contains activities that entail direct costs (such as technician time) and
activities that entail indirect costs (such as billing and collection). Although the ABC method is more complex and hence costlier than the traditional method, it
is the only way to accurately (more or less) estimate the costs of individual services. Activity cost detail on a per-procedure basis is shown in Table 2. In
essence, each activity is assigned a cost driver that is most highly correlated with the actual utilization of resources. Then the number of driver units, along
with the cost per unit, is estimated for each activity. The product of the number of units multiplied by the cost per unit gives the cost of each activity.
Finally, the activity costs are summed to obtain the total cost per procedure. Many of the activity costs cannot be estimated without a volume estimate. The best
estimate is that 50 procedures would be done each week, regardless of which alternative is chosen. Assuming the technician works 48 weeks per year, the annual
volume estimate is 2,400 procedures. Of course, a much greater total volume can be accommodated under Alternative 1, with three machines, than with Alternative 2,
with only one machine. However, to keep the initial analysis manageable, the decision was made to assume the same annual volume regardless of the alternative
chosen. In addition to the costs mentioned thus far, some other costs are thought to be relevant to the decision. First, in addition to the obvious costs of
operating the van (primarily gas expenses), it is estimated that annual maintenance costs will run about $1,000. Furthermore, annual maintenance costs on each of
the three machines under Alternative 1 are estimated at $500, while the annual maintenance costs for the single machine under Alternative 2 are estimated at a
higher $1,000 because of added wear and tear. Also, the manufacturer of the ultrasound machines has indicated that a 5 percent discount may be available if three
machines, as opposed to only one, are purchased. Finally, to have a rough estimate of total annual costs over the life of the equipment, it is necessary to make
assumptions about the useful life of the ultrasound machines and the van. Although somewhat controversial, the decision was made to assume a five-year life for
both the ultrasound machines and the van. Furthermore, the assumption was made that the value of these assets would be negligible at the end of five years. Assume
that you are the chairperson of the ad hoc task force. Your charge is to evaluate the two alternatives and to make a recommendation on which one to accept. Because
the revenues are assumed to be identical for the two alternatives, the decision can be made solely on the basis of costs. As part of the analysis, it will be
necessary to estimate the costs of the two alternatives on a per procedure and annual basis. In addition, any qualitative factors that are relevant to the decision
must be considered before the recommendation is made. To keep the analysis manageable, the task force was instructed to assume that operating costs remain constant
over the useful life of the equipment. For comparative purposes, this assumption is not too egregious because the activities are roughly the same for both
alternatives, and hence inflation would have a somewhat neutral impact on costs. TABLE 1 Panhandle Regional Medical Center Activities Associated with Alternatives
1 and 2 1. Appointment scheduling 2. Patient check-in 3. Ultrasound testing 4. Patient checkout 5. Film processing 6. Film reading 7. Billing and collection 8.
General administration 9. Transportation and setup (Alternative 2 only) Questions 1. Estimate the base case cost of each alternative regarding the provision of
ultrasound services. (For now, ignore the discount if three units are purchased.) 2. Which alternative has the lower total cost? 3. What value for travel and setup
costs would make the costs of the two alternatives the same? 4. Now consider the 5 percent discount. What impact does this discount have on the decision? What
discount amount would make the two alternatives equal in costs? 5. What subjective factors would influence the decision as to which alternative to choose? 6. What
is your final decision?

Can new medicines and vaccines be safely developed without animal testing?

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You will submit a 5-7 page argumentative research paper on one of the following topics. This research paper should be completed in proper MLA format (with in-text cites and a works cited page; no title page.) Your research paper will be graded for organization, content, correctness, unity, and effectiveness. Plagiarized papers or papers submitted without a verifiable works cited page will receive a zero. You must cite a minimum of three sources in your paper. Remember that once you declare your topic and take a position, you must prove it by providing evidence in the form of facts, expert opinions, previous studies, and statistics.

Develop one of the following thesis statements into a research paper.
Animal testing is necessary to develop new medicines and advance scientific knowledge.
Animal testing is unethical and should be outlawed.
Some of the issues in this argument:
What rights do animals possess? What rights do humans have to use animals as they wish? Can new medicines and vaccines be safely developed without animal testing? Do humans exploit animals when they keep them as pets and/or in zoos?
OR
The positive aspects of legalized gambling far outweigh the harmful side effects that occur.
The harmful side effects of legalized gambling far outweigh any positive effects.
Some of the issues in this argument:
What are the social and economic effects of legalized gambling on a community? What is the relationship between gambling and crime? Can the gambling industry regulate itself?
OR
Develop a thesis statement and subsequent paper which explore the following: To what extent should individuals have the protection of the law and the assistance of the medical establishment in terminating their own lives?