PROJECT ON HEALTH PROBLEM-HEALTH POLICY LINK: MEDICAL DEVICE SAFETY JANET JAIAH HMGT 310 PROFESSOR MICHAEL MARINO SEPTEMBER 4TH, 2016 HGMT 310 Assignment #1 Student Name: JANET JAIAH Assignment #1 Title: Medical Device Safety CFR Title 21 Health Problem: A medical device is, simply defined, any item used to diagnose, treat, or prevent disease, injury, or any other condition that is not a drug, biologic, or food. The official United States (U.S.) definition of the term 'device' can be found in the Federal Food Drug & Cosmetic Act (1998) enforced by the U.S. Food and Drug Administration (FDA), an agency of the U.S. Department of Health and Human Services. Medical devices range from items as simple as tongue depressors to more complex devices, such as ventilators. They represent some of the most innovative technologies developed in recent years. Yet regardless of how novel a device may be, the public expects, and the Food and Drug Administration requires that medical devices be safe, effective, and manufactured in accordance with current manufacturing practices. Medical devices can cause, or contribute to commonly known adverse events, such as the frequently reported problems of 'arching' and 'burns' from defibrillator pads. The FDA requires documentation of these wellknown events even though these events are included in the manufacturer's device labeling (Code of Federal Regulations 21, 2010). In medical device reports for which the reporter role was documented, nurses submitted 12,758, and risk managers submitted 26,512, of the 315,673 reports submitted. Nurses who work as risk managers are in a unique position to promote medical device safety. When nurses recognize a device problem, the FDA encourages them to use their facility's incident reporting system to alert appropriate staff regarding the problem or adverse event. Unfortunately for patients, not all device problems that occur are reported; yet unreported problems increase the potential for harm to patients and nurses alike. Healthy People 2020: In healthy People 2020, the Medical Product Safety decreases inappropriate use and the monitoring of adverse effects of the products. \"Many factors influence the safety of medical products and their effects on 2 patients. These factors include: A patient's genetic make-up and physiological condition, Drug composition (ingredients), manufacturing, and labeling, Appropriate use, Monitoring for adverse effects Incorrect use and inadequate monitoring of many medical products can cause adverse effects. For this reason, greater focus and emphasis on the safe use of such products is critical. Successfully reducing adverse events that result from medical products will improve overall treatment and increase the number of patients who benefit from medical products. \" Health People 2020\" Official Title and Citation of the Legislation: The Official Title is Medical Device Patient Safety Act and it was introduced to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. The Legislation is H.R.5866 - Medical Device Patient Safety Act H.R.5866 112th Congress (2011-2012) Describe the public The policy response is that: policy response: Medical Device Patient Safety Act - Directs the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs, to establish a program to enhance the oversight by the Food and Drug Administration (FDA) of medical device recalls. Requires the program to routinely and systematically assess: (1) information submitted to the Secretary pursuant to a device recall order issued under the Federal Food, Drug, and Cosmetic Act (FDCA); and (2) information required to be reported by a device manufacturer to the Secretary regarding the manufacturer's correction or removal of a device. Requires the Secretary to use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices. Requires such program to be designed to identify such things as recall trends, the causes of recalls, and the time to complete a recall. Requires the Secretary to develop explicit criteria for assessing whether a person subject to a recall order or the manufacturer's reporting requirement has performed an effective correction or removal action. Requires the Secretary to document and publish specified information 3 concerning termination of a recall. Permits the Secretary to conditionally clear for introduction into interstate commerce for commercial distribution a medical device intended for human use if such medical device is cleared pursuant to specified FDCA reporting requirements concerning the introduction of devices into interstate commerce. Permits the Secretary, as part of such conditional clearance, to: (1) impose specified restrictions on the sale, distribution, or use of the device; (2) require specified labeling for the device; and (3) require the maintenance of specified records that enable the FDA to track the device and determine the safety and effectiveness of the device. Status: It was introduced into the house on 05/30/2012 by Rep. Braley Bruce L. [D-IA-1] The Committee responsible is House - Energy and Commerce Latest Action was 06/01/2012. It was Referred to the Subcommittee on Health Conclusion: In my opinion, the health policy adequately addressed the health problem identified and in detail too. Any violations will be dealt with appropriately as they are working endlessly to reduce occurrences of faulty devices. Resources for Updates: The resource a health organization may use to check for updates are: www.healthypeople.gov/2020/topics-objectives/topic/medical-productsafety www.congress.gov/bill/112th-congress/house-bill/5866 4 REFERENCES http://www.fda.gov/MedicalDevices/Safety/default.htm www.healthypeople.gov/2020/topics-objectives/topic/medical-product-safety www.congress.gov/bill/112th-congress/house-bill/5866 www.regulations.gov 21 CFR Part 801 - 820 Citation: Swayze, S., Rich, S., ( October 17, 2011) "Promoting Safe Use of Medical Devices" OJIN: The Online Journal of Issues in Nursing Vol. 17 No. 1. 5 Submit Files - Assignment #2 (17.5 points): Policy Implementation Hide Submission Folder Information Submission Folder Assignment #2 (17.5 points): Policy Implementation Instructions Assignment #2- Policy Implementation (17.5 points) Build on Assignment #1. You will cover the same health problem and the same policy unless otherwise indicated by your instructor. Some remedial action on Assignment #1 may be required in order for students to proceed to Assignment #2.Complete the following using the format provided. Except for titles, narrative format is expected with complete sentences. The table should be single spaced maximum 2.5 pages. Also include a cover page and a reference page in APA Format. HGMT 310 Assignment #2 Student Name: Type your name here. Assignment #2 Title: Provide a short name and the official title of the legislation. Agency Responsible: Identify the agency and subunit (such as a bureau or office) responsible for implementing the policy. If multiple agencies are involved indicate who is responsible for what. Enforcement: What federal or state agency is responsible for enforcement? What are the key areas for enforcement? Implementation: How is the legislation implemented? What federal or state agency is charged with its implementation? Are local public health departments involved? Are collaborating organizations engaged to achieve the aims of the policy? Are citizen's involved? Are health provider organizations? Are grants awarded? Impact on Health Service Organizations: What does a Health Care Manager need to know about this legislation and the related implementation? Include five bullets of how this legislation impacts health services organizations operating in your home state. Resource: What resource would a health organization utilize to find updates regarding the impact policies have on them? All sections of Assignment #2 are required