ANSI AAMI PAC49-1993 (2000) PDF

Full title and description

ANSI/AAMI PAC49-1993 (R2000) — Pacemaker Emergency Intervention System. Specifies labeling and performance requirements for a pacemaker emergency intervention system (EIS) used to permit temporary conversion of an implanted bradycardia pacemaker to a defined high-output or standard mode (typically via a magnet) for emergency use when the pacemaker is believed to be operating in a nonstandard or not-understood manner. The EIS is intended for use in emergency rooms, clinics or other locations where a clinician skilled in pacemaker reprogramming may not be immediately available; follow-up programming by a qualified clinician is required after use.

Abstract

This standard defines minimum labeling, performance and user instructions for an Emergency Intervention System (EIS) intended to interact with implanted bradycardia pacemakers. It describes the functional effect of the EIS (magnet-induced mode change), basic safety and performance expectations, and recommended warnings and follow-up procedures to ensure patient safety when the EIS is used in urgent situations. The standard was prepared and published under AAMI and has been recorded with ANSI designation.

General information

• Status: Active / ANSI-approved designation (originally published 1993; recorded with a 2000 reaffirmation record in some listings).
• Publication date: 1993-09-01 (ANSI/AAMI PAC49-1993; listings also show R2000 / 2000 notation).
• Publisher: AAMI (Association for the Advancement of Medical Instrumentation); ANSI-designated where applicable.
• ICS / categories: Medical devices / medical electrical equipment (typical ICS grouping for pacemaker-related device standards: 11.040.01 / 11.040.10 range).
• Edition / version: ANSI/AAMI PAC49-1993 (reaffirmation / record noted for 2000 — often shown as PAC49-1993 (2000) in bibliographies).
• Number of pages: 8 pages (concise technical specification and labeling/performance requirements).

Scope

The standard applies to Emergency Intervention Systems (EIS) intended to interact with implanted bradycardia cardiac pacemakers by producing a predictable, temporary mode change (for example, via the application of a magnet) to place the pacemaker into a defined high-output or standard pacing mode. It covers labeling, instructions for use, intended clinical contexts (emergency/acute settings), performance expectations and warnings/precautions. It does not replace definitive reprogramming performed by a qualified pacemaker clinician and does not address implantable device design beyond the interaction addressed.

Key topics and requirements

• Definition of an Emergency Intervention System (EIS) and its intended clinical purpose.
• Functional description of magnet-induced pacemaker behavior and the expected temporary mode changes.
• Labeling and instructions for use designed for emergency application by clinicians who may not be pacemaker specialists.
• Performance criteria to ensure predictable interaction with conforming implanted bradycardia pacemakers.
• Safety warnings, contraindications, and mandatory follow-up recommendations after EIS use.
• Requirements for documentation, marking, and minimum information to accompany the device for clinicians.

Typical use and users

Typical users are emergency department clinicians, paramedics, clinic staff and other healthcare providers who may encounter a patient with an implanted bradycardia pacemaker operating in an unexpected manner. The EIS is intended for urgent, temporary intervention to stabilize pacing until a cardiac device specialist can perform definitive evaluation and reprogramming. Manufacturers of EIS devices and labeling writers also use the standard to ensure compliance and consistent instructions.

Related standards

Relevant device and cardiac device standards and documents to consult alongside PAC49 include IEC/EN standards for external and implantable cardiac devices (for example, IEC 60601 series particular standards for cardiac devices and IEC/ISO documents addressing implantable pacemaker safety and EMC), AAMI guidance for cardiac device testing, and clinical device interoperability/testing publications. These related standards provide device-level safety, performance and testing requirements that complement the emergency interaction focus of PAC49.

Keywords

pacemaker, emergency intervention system, EIS, magnet reversion, bradycardia pacemaker, AAMI, ANSI, labeling, emergency use, device instructions

FAQ

Q: What is this standard?

A: ANSI/AAMI PAC49-1993 (R2000) is a short technical standard that specifies labeling and performance requirements for a Pacemaker Emergency Intervention System (EIS) intended to produce a predictable, temporary mode change in implanted bradycardia pacemakers for emergency use.

Q: What does it cover?

A: It covers the intended function of an EIS (magnet-induced mode change), minimum labeling and instructions for emergency use, safety warnings and recommended clinical follow-up after use. It is focused on the emergency interaction and not on detailed implantable pacemaker internal design.

Q: Who typically uses it?

A: Emergency and acute-care clinicians, paramedics, clinic staff, medical device manufacturers of EIS products, and regulatory/quality professionals drafting labeling and instructions for such devices.

Q: Is it current or superseded?

A: The original publication date is 1993 with bibliographic records showing a 2000 reaffirmation/record (PAC49-1993 (2000)). Users should verify the current status with AAMI or ANSI for any later revisions or withdrawals before relying on the standard for regulatory or design work.

Q: Is it part of a series?

A: PAC49 is a focused AAMI/ANSI standard addressing emergency intervention interaction for pacemakers. It is complementary to broader cardiac-device and medical-electrical equipment standards (for example, IEC 60601 family parts for cardiac devices and related implantable cardiac device standards). Consult those IEC/AAMI standards for device-level safety and test methods.

Q: What are the key keywords?

A: Pacemaker, EIS, magnet, bradycardia, emergency intervention, labeling, AAMI, ANSI.