PCEI flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

Beneficence and non-maleficence

Beneficence is acting for the patient's benefit; non-maleficence is avoiding harm. Clinical engineers weigh both when selecting devices, prioritizing maintenance, and recommending use restrictions.

Conflict of interest disclosure

Any gift, fee, travel, or equity that could bias a procurement or evaluation decision must be disclosed in writing to the employer before the decision is made.

Competence boundary rule

A clinical engineer lacking documented training on a device class must escalate to a qualified colleague or the manufacturer rather than perform service, even for apparently routine tasks.

Whistleblower protection scope

Good-faith reports of device safety hazards or regulatory violations to an internal compliance channel or external regulator are legally protected from retaliation in most jurisdictions.

Patient data confidentiality duty

Device-generated clinical data, including alarm histories and therapy settings, may only be discussed on a need-to-know basis; unauthorized discussion breaches ethics codes and privacy law.

Acceptance testing purpose

Before clinical use, verify the device matches the purchase specification, passes safety tests, and record serial number, software version, and accessories in the inventory system.

CMMS inventory core fields

A maintenance system record should include unique asset ID, manufacturer, model, serial number, location, acquisition date, warranty end, PM schedule, and full service history.

Availability formula

Availability equals scheduled time minus downtime, divided by scheduled time. It is paired with mean time between failures and mean time to repair for reliability analysis.

Electrical safety test set

Patient-connected equipment testing typically covers protective earth resistance, chassis leakage current, and patient leakage current, compared against IEC 60601-1 limits.

Decommissioning requirements

Retirement includes sanitizing stored protected health information, archiving or removing the maintenance record, and disposing of batteries and hazardous components compliantly.

Life-cycle cost replacement rule

Replacement decisions compare cumulative maintenance cost against replacement cost, weighted by parts-availability risk, clinical demand, and remaining useful life.

FDA device risk classes

Class I devices are low risk under general controls; Class II moderate risk with special controls and often a 510(k); Class III high risk requiring premarket approval.

510(k) substantial equivalence

A 510(k) submission demonstrates that a new device is substantially equivalent to a legally marketed predicate device in intended use and technological characteristics.

EU MDR risk classes

Regulation 2017/745 assigns classes I, IIa, IIb, and III, requires notified body involvement for most classes, and mandates unique device identification and post-market surveillance.

IEC 60601-1 scope

This is the general safety standard for medical electrical equipment; the -1-2 collateral covers electromagnetic compatibility and other collaterals address specific modalities.

ISO 14971 role

ISO 14971 defines the medical device risk management process, from hazard identification through risk control, residual risk evaluation, and post-production monitoring.

IEC 62304 safety classes

Software safety class A means no injury is possible, B means non-serious injury is possible, and C means death or serious injury is possible.

Risk control hierarchy

Controls are applied in order: inherently safe design first, then protective measures in the device or process, then information for safety such as labeling and training.

FMEA risk priority number

RPN equals severity multiplied by occurrence multiplied by detection. Higher values prioritize which failure modes receive mitigation effort first.

Root cause analysis method

A structured timeline, causal factor charting, and techniques such as five whys or fault tree analysis move the investigation from proximate cause to underlying system cause.

Incident evidence preservation

Quarantine the device, retain accessories and disposables, capture alarm logs and error codes, and document the clinical sequence before any repair or reset occurs.

Use error as system issue

Human factors cause many device incidents. Use error reflects design and workflow weaknesses and should be analyzed as a system problem, not solely operator failure.

HL7 FHIR characteristics

FHIR uses RESTful application programming interfaces with JSON or XML resource representations, supporting modern interoperability alongside the older HL7 version 2 messaging standard.

DICOM standard purpose

DICOM governs medical imaging storage and transfer, including modality worklists, image objects, and a defined data dictionary of attributes for each object.

IEC 80001-1 principle

It addresses risk management when medical devices are connected to IT networks; the responsible organization must assess network risk before permitting connection.

Premarket cybersecurity package

FDA expectations include a threat model, security risk assessment, software bill of materials, and a coordinated vulnerability disclosure policy in the submission.

Device hardening baseline

Change default credentials, disable unused services and ports, segment clinical networks, patch on a risk-based schedule, and maintain a current device asset inventory.

Network segmentation rationale

Separating clinical device networks from enterprise and guest networks, with firewalls or unidirectional gateways, limits lateral movement from compromised IT systems.

Critical path definition

The critical path is the longest dependent sequence of project tasks; any delay on it delays the project end date unless the schedule is compressed.

Earned value variances

Cost variance equals earned value minus actual cost; schedule variance equals earned value minus planned value. Negative values indicate cost overrun or schedule delay.

Stakeholder influence-interest grid

Stakeholders are mapped by influence and interest; those high in both require active management and frequent direct communication throughout the project.

Capital business case elements

A device purchase case includes clinical need, volume projections, total cost of ownership, reimbursement or revenue impact, and the risk of taking no action.