Healthcare is one of the most complex and tightly interconnected environments in the world. Patients interact with medical devices, software systems, medications, clinical workflows, and multiple clinicians—all of which must function safely and consistently. Because the stakes are so high, even a minor issue can escalate into patient harm.

To manage this risk proactively, healthcare organizations and medical device teams increasingly blend two powerful methods:

1. Failure Mode and Effects Analysis (FMEA) – a structured technique to identify how processes or components might fail
2. ISO 14971 risk management – the globally recognized standard for identifying hazards, estimating risks, implementing controls, and maintaining traceability throughout the life cycle of a medical device

Although ISO 14971 is written for medical device manufacturers, healthcare organizations benefit greatly from adopting its terminology—hazards, hazardous situations, harms, sequences of events, and residual risk—because this language focuses directly on patient impact rather than just process breakdowns.

The result is an FMEA process that goes beyond operational efficiency and aligns with how regulators, auditors, and patient-safety experts think about risk.

ISO 14971 and Healthcare Risk Management

ISO 14971 sets expectations for how medical device manufacturers and integrators must manage risk. It requires organizations to:

• Identify hazards associated with a device or system
• Identify the foreseeable sequence of events that could expose people to the hazard
• Identify the hazardous situations in which harm could occur
• Define harms precisely and clinically
• Estimate risk based on the probability of harm and severity of harm
• Implement risk control measures
• Evaluate residual risk after controls
• Maintain a complete risk management file

While ISO 14971 is not a hospital regulation, many healthcare systems use its principles because they offer:

• A more rigorous approach to clinical risk
• Stronger alignment with manufacturers
• Better documentation for accrediting bodies
• A clearer understanding of how device + human + workflow failures combine to cause harm

This makes ISO 14971 terminology the preferred language for safety-focused healthcare teams.

Key ISO 14971 Terms Every Healthcare FMEA Should Use

Hazard

A potential source of harm.

In healthcare, common hazards include electrical energy, high pressure, concentrated medications, software miscalculations, biological contamination, or excessive radiation.

Hazardous Situation

A circumstance in which a patient, user, or environment is exposed to a hazard.

Example: a ventilator delivering insufficient tidal volume due to a misconfiguration.

Harm

Physiological injury or damage to health, such as hypoxia, overdose toxicity, infection, or tissue injury.

Sequence of Events

The chain of failures or human actions that lead from hazard → hazardous situation → harm.

This is crucial because healthcare incidents usually involve multiple contributing factors.

Risk

The combination of the probability of harm and the severity of that harm.

Risk Control Measures

Actions designed to eliminate a hazard or reduce the probability or severity of harm. Controls may include design changes, workflow modifications, alarms, competency requirements, or automation.

Residual Risk

Risk that remains after applying controls. ISO requires evaluating whether the remaining risk is acceptable.

Using this terminology makes your FMEA not only more accurate but also more credible to regulators, auditors, and medical device customers.

How FMEA Supports ISO 14971 in Healthcare

Traditional FMEA focuses on process-level failures:

• Failure modes
• Causes
• Effects
• Severity
• Occurrence
• Detection
• RPN

However, this approach alone does not examine patient harm in a way aligned with ISO 14971. In healthcare and medical device scenarios, FMEA becomes far more valuable when mapped to ISO 14971:

• Failure modes → potential contributors to hazards
• Effects → describe the hazardous situation created
• Outcome → describe the actual harm to the patient
• Actions → become formal risk control measures
• Re-scoring → becomes residual risk evaluation

In other words, FMEA supports ISO 14971—but ISO 14971 defines the structure.

HFMEA (Healthcare FMEA, developed by the VA) already incorporates some of this thinking through hazard scoring and decision trees, which align well with ISO-style analysis.

ISO 14971–Aligned FMEA Process for Healthcare

1. Define the Scope

Select a device, workflow, or system where medical device use, software, and human factors interact. Examples include:

• Infusion therapy
• Blood transfusion
• ICU ventilator workflows
• Surgical workflows
• Medication administration
• EHR-to-device interoperability

FMEA should reflect both device functionality and the clinical-use environment.

2. Build a Multidisciplinary Team

Healthcare risk cannot be understood from one discipline alone. Include:

• Clinicians (nurses, physicians)
• Pharmacists
• Biomedical engineers
• Device super-users
• Human factors specialists
• Health IT professionals
• Quality and risk leaders

This ensures analysis captures real-world use—not just theoretical design.

3. Map the Process or Use Scenario

Document:

• Intended use
• Foreseeable misuse
• Steps in the workflow
• Device-user interactions
• Software dependencies
• Environmental factors

This step reveals the underlying structure of risk.

4. Identify Hazards

List all potential sources of harm, such as:

• Mechanical energy (e.g., pressure from a ventilator)
• Incorrect software output (e.g., wrong dose calculation)
• Biological contamination
• Incorrect medication concentration
• Electrical failure

Both device-related and workflow-related hazards should be included.

5. Identify Sequences of Events and Hazardous Situations

Describe:

• How failures accumulate
• How user actions or misinterpretations contribute
• How the environment or workflow can amplify risk

Healthcare incidents almost always come from a combination of factors—this step captures that.

6. Identify Harms

Describe harms in clear clinical language. Examples:

• Hypoxia
• Bradycardia
• Tissue necrosis
• Sepsis
• Overdose-related respiratory depression
• Incorrect treatment due to a false laboratory result

This directly connects engineering analysis to clinical outcomes.

7. Estimate Risk (Probability + Severity of Harm)

Unlike industrial FMEA, ISO 14971 requires estimating:

• The severity of the potential harm
• The probability of that harm occurring

Probability accounts for both the sequence of events and the likelihood of resulting harm.

8. Apply Risk Control Measures

Risk controls may include:

Design controls

• Software limits
• Hard stops
• Automated checks
• Improved physical design

Protective measures

• Alarms and alerts
• Interlocks
• Guards

Information for safety

• Instructions for use
• Training
• Labeling

Workflow improvements

• Standardized order sets
• Double-verification for high-risk drugs
• Clinical checklists

In healthcare, many controls are procedural rather than purely mechanical.

9. Evaluate Residual Risk

After controls:

• Re-estimate severity and probability
• Determine whether residual risk is acceptable
• If not, add more controls or justify with benefit–risk analysis

Residual risk evaluation is a core ISO 14971 requirement.

10. Maintain and Update the Risk Management File

Document every relationship:

Hazard → Sequence of events → Hazardous situation → Harm → Risk estimate → Controls → Residual risk

Healthcare teams should update the file whenever:

• Processes change
• New equipment is introduced
• Incident reports identify new issues
• Software is updated
• New regulatory expectations emerge

Examples of ISO 14971–Aligned Hazards and Harms

Medication Safety

• Hazard: concentrated drug solution
• Hazardous situation: administered without dilution
• Harm: acute toxicity or organ injury

Infusion Pump Use

• Hazard: incorrect software calculation
• Hazardous situation: pump runs at unintended rate
• Harm: respiratory depression, fluid overload

Diagnostic Processes

• Hazard: contaminated or mislabeled specimen
• Hazardous situation: incorrect lab result
• Harm: wrong treatment or delayed diagnosis

Ventilation Systems

• Hazard: hardware or configuration error
• Hazardous situation: patient receives insufficient ventilation
• Harm: hypoxia, cardiac arrest

These examples reflect true ISO 14971 terminology and realistic clinical scenarios.

How APIS® IQ-Software Supports ISO 14971–Aligned FMEA

APIS® IQ-Software helps teams perform healthcare and medical device risk management with:

• Built-in structures for hazards, hazardous situations, and harms
• Traceability across all risk elements
• Connections between FMEA, fault trees, and hazard analysis
• Action tracking for risk control measures
• Consistent risk scoring aligned with ISO matrices
• Lifecycle updates for devices and processes
• Clear documentation for audits and regulatory reviews

This helps both device manufacturers and healthcare organizations align with ISO expectations while still benefiting from the familiar workflow of FMEA or HFMEA.

Conclusion

FMEA becomes significantly more powerful in healthcare when teams adapt it to the terminology and structure of ISO 14971. By focusing explicitly on hazards, hazardous situations, harms, risk controls, and residual risk, organizations shift from analyzing process failures to analyzing patient risk, which is exactly how regulators and safety professionals view it.

At APiS North America®, we help organizations integrate FMEA with ISO 14971–aligned risk management. With APIS® IQ-Software, we provide the tools needed to identify hazards, analyze sequences of events, evaluate harms, and manage risk controls with full transparency and traceability. We’ve seen how ISO-aligned risk analysis elevates patient safety and creates safer, more resilient healthcare systems.