Advancing Health Care Risk Management CPHRM ASHRM Study Notes

The IOM’s quality framing highlights three categories of quality problems:underuse(failing to provide beneficial care),overuse(providing care where harms outweigh benefits), andmisuse(errors/defects in delivering appropriate care). This triad matters to risk management because harm arises not only from mistakes (misuse) but also fromomissions(underuse) andunnecessary interventions(overuse). For example, missing a diagnostic test can cause deterioration (underuse), while ordering a risky, non-indicated procedure can cause avoidable complications (overuse). Misuse connects strongly to patient safety incident analysis and reliability engineering. Together, these categories provide a comprehensive lens for prioritizing improvement: reduce preventable adverse events, close evidence-based gaps, and avoid low-value care that increases complications and cost. Using this IOM model supports a balanced quality/risk program that prevents harm across the full spectrum of clinical decision-making and care delivery.

Under Health Care Risk Management standards recognized by ASHRM and the American Hospital Association Certification Center, the Safe Medical Devices Act SMDA is part of the FDA’s post market surveillance system for medical devices. The SMDA requires healthcare facilities to report to the FDA and, in some cases, to the manufacturer when a medical device has or may have caused or contributed to a patient death or serious injury. This mandatory reporting system enhances device safety monitoring and supports regulatory oversight after products enter the market.

EMTALA governs emergency medical screening and stabilization obligations, not device reporting. The Occupational Safety and Health Act focuses on workplace safety for employees rather than patient device-related injuries. Patient Safety Organizations operate under the Patient Safety and Quality Improvement Act and facilitate voluntary reporting of patient safety events, but they do not replace FDA-mandated device reporting requirements.

Legal and regulatory objectives in healthcare risk management emphasize compliance with federal reporting statutes, timely submission of required reports, and maintenance of documentation to mitigate regulatory exposure. Therefore, the Safe Medical Devices Act is the correct answer regarding mandatory FDA post market surveillance reporting for device-related deaths or injuries.

The HIPDB was established to help combathealthcare fraud and abuse, while the NPDB historically focused on practitioner competence and professional conduct (including items like malpractice payments and certain adverse actions). HRSA explains that HIPDB is no longer separate and that its information is now collected and disclosed through the NPDB following the 2013 merger. For risk managers, the objective is to ensure credentialing, contracting, and compliance teams understand the expanded scope and proper use: querying supports safer hiring/privileging decisions and reduces negligent credentialing risk, while reporting supports system integrity. Organizations must also ensure due process and correct categorization of reportable events to avoid wrongful reporting exposure.

According to Health Care Risk Management standards supported by ASHRM and the American Hospital Association Certification Center, the Safe Medical Devices Act SMDA establishes mandatory reporting requirements for certain healthcare facilities when a medical device has or may have caused or contributed to a patient death or serious injury. These requirements apply to device user facilities, which include hospitals, nursing homes, and ambulatory surgical facilities.

Hospitals are explicitly required to report device-related deaths to both the FDA and the manufacturer, and serious injuries to the manufacturer or the FDA if the manufacturer is unknown. Nursing homes and ambulatory surgery centers are also considered device user facilities under the Act and must comply with similar reporting obligations.

Physician offices, however, are generally not classified as device user facilities under SMDA reporting rules and therefore are not subject to the same mandatory reporting requirements, although voluntary reporting is encouraged.

Legal and regulatory objectives emphasize timely compliance with FDA reporting mandates, maintenance of documentation, and coordination with manufacturers and regulatory authorities to mitigate risk and enhance patient safety. Therefore, the SMDA reporting requirements apply to nursing homes, ambulatory surgery facilities, and hospitals.