BME Mid Term Engineered Medical Devices

★ Venipuncture

Puncturing a vein to draw blood or deliver medication.

Phlebotomist

Healthcare professional trained to collect blood samples.

★ Ethnography

Observing people in their real environment to understand behaviors, workflows, and pain points.

★ CAGR

Compound Annual Growth Rate; average yearly growth rate over multiple years, assuming compounded growth.

★ IVD

In Vitro Diagnostics; testing samples removed from the body to diagnose or monitor health.

★ DHHS

Department of Health and Human Services; U.S. public-health department overseeing the FDA.

★ FDA

Food and Drug Administration; DHHS agency regulating medical-device safety and effectiveness (and drugs, food, and biologics).

★ Taxonomy

System of naming and classifying items into groups.

★ Clinical axis

What medical need a device addresses and how it is used clinically.

★ Medical device

Product intended to diagnose, prevent, treat, or mitigate disease or a medical condition.

★ General controls

The FDA's basic regulatory requirements for making, labeling, selling, and monitoring medical devices to ensure safety and effectiveness. Apply to all device classes (I, II, and III).

Remember: General Controls = basic FDA requirements for ALL medical devices.

★ Special controls

Additional requirements for Class II devices beyond general controls.

Special Controls: Additional FDA requirements for Class II medical devices when General Controls alone are insufficient to ensure safety and effectiveness. May include extra testing, performance standards, labeling, and monitoring.

Remember the difference:

• General Controls: Basic FDA requirements for ALL medical devices.

• Special Controls: Additional requirements for Class II devices because General Controls alone aren't enough.

★ Class I device

Low-risk devices that generally require only FDA General Controls to ensure safety and effectiveness. They present minimal risk of injury and typically do not require premarket review.
Remember: Low risk → General Controls

★ Class II device

Moderate-risk devices requiring General Controls and Special Controls because General Controls alone are insufficient. Many require 510(k) clearance by demonstrating substantial equivalence to a predicate device. Examples: powered wheelchair and blood pressure monitor.

Remember: Moderate risk → General + Special Controls → Often 510(k)

★ Class II critical

A moderate-risk Class II medical device whose failure or malfunction could cause serious harm to the patient, particularly when supporting or sustaining life. Requires General and Special Controls. Example: Infusion pump.

★ Class III device

High-risk devices that often sustain or support life, are implanted, or present a potentially unreasonable risk of injury. They generally require Premarket Approval (PMA), involving extensive scientific and clinical evidence of safety and effectiveness.

Remember: High risk → Highest regulatory scrutiny → Usually PMA

★ 510(k) premarket notification

FDA Premarket Notification (510(k)); clearance pathway demonstrating substantial equivalence to a legally marketed predicate device, generally for Class II devices.

★ Predicate device

Legally marketed device used as a comparison for substantial equivalence.

★ De novo

An FDA regulatory pathway for new, low-to-moderate-risk medical devices that have no existing predicate device. Establishes a new device classification and regulatory requirements.

Remember:

• 510(k): Has a predicate device → demonstrates substantial equivalence.

• De Novo: No predicate device → creates a new classification.

• PMA: High-risk Class III devices → requires extensive evidence of safety and effectiveness.

★ PMA

PMA (Premarket Approval): The FDA's most rigorous review process for high-risk (Class III) medical devices, requiring extensive scientific and clinical evidence to demonstrate the device's safety and effectiveness before it can be marketed.

Key things to remember:

• Class III: Primarily used for high-risk devices.

• Safety and effectiveness: Must be demonstrated through extensive evidence.

• FDA approval: Required before marketing devices subject to PMA.

• Example: Implantable defibrillator.

Quick comparison

• 510(k): Demonstrates substantial equivalence to an existing predicate device → FDA clearance.

• De Novo: New low-to-moderate-risk device without a predicate → FDA classification and marketing authorization.

• PMA: High-risk device requiring extensive safety and effectiveness evidence → FDA approval.

★ QSR

QSR (Quality System Regulation): FDA regulations that establish quality system requirements for manufacturers of finished medical devices sold in the U.S., ensuring devices are consistently designed, manufactured, and controlled to meet safety and quality requirements.

Important things to remember:

• Purpose: Ensure medical devices consistently meet quality and safety requirements.

• Applies to: Manufacturers of finished medical devices.

• Regulation: 21 CFR Part 820.

• Design controls: Your notes specifically reference 21 CFR 820.30.

Easy way to remember:

QSR = The FDA's rules for how manufacturers maintain quality throughout medical device development and production.

Now QMSR —> Quality Management System Regulation

★ 21 CFR 820.30

FDA design-control requirements referenced in the glossary.

★ PRS

Product Requirement Specification; document stating intended use, performance, physical, reliability, environmental, user-interface, safety, regulatory, labeling, packaging, and cost requirements.

★ Intended use

Purpose and conditions of use: WHO uses it, WHERE, WHY, HOW LONG, criticality, and interactions with other devices.

★ MAUDE

Manufacturer and User Facility Device Experience; FDA database of individual medical-device adverse-event and malfunction reports.

★ ISO 13485

International Organization for Standardization (ISO) 13485; medical-device quality management systems.

★ ISO 14971:2000

International Organization for Standardization (ISO) 14971; medical-device risk management across the product lifecycle.

★ ANSI

American National Standards Institute; coordinates U.S. voluntary standards.

★ AAMI

Association for the Advancement of Medical Instrumentation; develops medical-device standards.

★ ASTM

ASTM (formerly American Society for Testing and Materials); develops materials and testing standards.

Proximal

Closer to the point of origin or attachment.

Distal

Farther from the point of origin or attachment.

Lumen

Hollow channel inside a tube or device.

Proximal port

Opening near the proximal end used to access a lumen.

★ Bloodletting

Historical practice of removing blood to treat or prevent illness.

Trepanation

Making a hole in the skull; an ancient surgical procedure.

Sphygmomanometer

Device used to measure blood pressure.

Mitral valve

Valve between the left atrium and left ventricle.

CDRH

Center for Devices and Radiological Health; FDA center overseeing medical devices and radiation-emitting products.

Auscultate

Listen to internal body sounds, usually with a stethoscope.

Ipsilateral

On the same side of the body.

★ Accident

Unplanned, undesired event, usually with harmful consequences.

★ Adverse event (AE)

Undesirable health event associated with medical care or device use.

★ Adverse device event (ADE)

Adverse event associated with a medical device.

★ Medical error

Planned action fails or an incorrect plan is used.

★ Error of execution

Correct plan, but the action is performed incorrectly.

★ Error of planning

Wrong plan chosen to achieve the goal.

★ Error of omission

Failing to perform a required action.

★ Error of commission

Performing an incorrect action.

★ Near miss

An error or unsafe event that could have caused harm but did not, due to detection or chance.

★ Diagnostic error

Missed, delayed, or incorrect diagnosis or test interpretation.

★ Medication error

Mistake in prescribing, dispensing, or administering medication.

★ Surgical error

Mistake during surgery, such as wrong-site surgery or a retained instrument.

★ Communication failure

Important patient information is lost or misunderstood between care providers.

★ Slip

Correct goal, but wrong physical action.

★ Mistake

Incorrect plan or mental model.

★ Lapse

Memory failure, such as forgetting a required step.

★ Violation

Knowingly bypassing a rule or procedure.

★ Hazard

Potential source of harm.

★ Hazardous situation

Circumstance in which someone or something is exposed to a hazard.

★ Harm

Injury, damage to health, property, or the environment.

★ Dalkon Shield

Unsafe 1970s IUD; multifilament tail string could carry bacteria into uterus. Helped prompt the 1976 Medical Device Amendments.

★ 1976 Medical Device Amendments

Expanded FDA authority to regulate medical devices for safety and effectiveness.

CPAP

Continuous Positive Airway Pressure; provides positive air pressure to help keep the airway open.

Intubation

Placing a tube in the trachea to maintain breathing.

★ Pneumothorax

Collapsed lung caused by air entering the space around the lung.

Ambu bag

Handheld device for manually assisting ventilation.

★ Cardinal Rule 1

Make it easy to determine what actions are possible at any moment.

★ Cardinal Rule 2

Make things visible, including a conceptual model of the system and the results of actions.

★ Cardinal Rule 3

Make it easy to evaluate the current state of the system.

★ Cardinal Rule 4

Make all aspects of design consistent with user expectations; follow natural mappings.

★ Cardinal Rule 5

Consider the use environment and other things the device must interact with.

★ Cardinal Rule 6

Consider the user and their physical and cognitive capabilities and limitations.

★ Cardinal Rule 7

Do real-world user testing.

★ Natural mapping

Controls and actions correspond intuitively to their effects.

★ EMI/RFI

Electromagnetic Interference / Radio-Frequency Interference; disturbances that disrupt electronics or wireless communication.

★ Ergonomics

Designing tasks and tools to fit users physical and cognitive abilities.

★ Anthropometrics

Measurements of human body dimensions used in design.

★ IHA / PHA

Initial Hazard Analysis / Preliminary Hazard Analysis; early TOP-DOWN identification of potential hazards, causes, severity/probability-based risks, and intended mitigations.

★ IHA Step 1

Develop a hazard list from previous failures/recalls, clinician interviews, engineering experience, and deduction.

★ IHA Step 2

Work with the design team to identify probable causes for each hazard.

★ IHA Step 3

Assign a numerical risk index based on severity and probability of occurrence.

★ IHA Step 4

Mitigate hazards with design features or system responses; use labeling as a last resort.

★ Living hazard analysis

Safety analysis updated throughout development as new information appears.

★ Risk index

Rating based on severity and probability of occurrence.

★ FMEA

Failure Modes and Effects Analysis; BOTTOM-UP method examining how each component/process might fail, its effects and causes, and its risk.

★ FMEA RPN

Risk Priority Number = Severity (S) × Occurrence (O) × Detection (D); used to prioritize potential failure modes.

★ FTA

Fault Tree Analysis; TOP-DOWN method starting with an unwanted system event and tracing combinations of underlying causes using AND/OR logic gates.

★ Fishbone diagram

Cause-and-effect diagram; starts with a failure/problem and branches backward into categories of possible causes.

★ Fault

Abnormal or undesirable system state.

★ Failure

Loss of ability to perform a required function.

★ DHF

Design History File; records documenting that a device was developed according to the approved design plan and met design requirements.

★ Hazard mitigation

Design changes or system responses that eliminate or reduce risk.

★ Affordance

Design feature that suggests how an object can be used.

★ Forcing function

Design feature that prevents an unsafe action or forces deliberate consideration before proceeding.

★ Error-tolerant design

Design that prevents user mistakes from causing hazardous outcomes.

★ Labeling as last resort

Prefer safer design and safeguards over relying only on warnings.

Flange

Finger grip on syringe or needle hub that helps stabilize handling.

Palpate

Examine by touching or pressing with the fingers.

Septum

Puncturable seal that helps prevent fluid leakage.