OC-2025-130285 Automated External Defibrillator

The U.S. Food and Drug Administration (FDA) is seeking market feedback for the replacement, maintenance, and support of its Automated External Defibrillator (AED) program, documented under the Sources Sought Notice OC-2025-130285. The FDA aims to identify qualified vendors capable of supplying and servicing approximately 400 AED units across 87 cities in 34 states. Key requirements include the procurement of FDA-approved AEDs, preventive maintenance services, AHA-certified CPR/AED training for up to 500 employees annually, and comprehensive program administration support. Interested businesses must submit a Capability Statement detailing their qualifications, relevant experience, and information regarding their ability to meet small business set-aside criteria. Specifications for the AEDs include an 8-year warranty, a minimum 4-year battery life, and compliance with regulatory standards. Responses are due by July 23, 2025, highlighting the government's intention to assess both large and small business capacities for this public health initiative. This notice serves as a preliminary step in developing a potential Request for Proposal, guiding the acquisition strategy to ensure effective public health support through AED deployment.

The document outlines a "Sources Sought Notice" for Automated External Defibrillator (AED) services, aimed at gathering information from potential providers. It focuses on aspects such as experience, compliance with regulations, service scope, documentation, response times, parts supply, training, liability insurance, and pricing structure. Key inquiries include the duration of experience in servicing AEDs, technician certifications, prior federal agency engagements, methods for ensuring regulatory compliance, and details about maintenance services offered. The document emphasizes the importance of documentation post-service, readiness reporting, and customer support availability, including 24/7 options. Additionally, it seeks clarity on liability coverage and indemnification for servicing errors, alongside provider pricing models and any potential hidden fees. This inquiry serves as a preliminary step in evaluating AED service providers, ensuring they meet necessary federal standards and capabilities to support AED maintenance and training on devices for public safety.

The FDA's Public Access Defibrillation (PAD) Program aims to maintain a safe environment for employees and visitors by managing approximately 399 Automated External Defibrillators (AEDs) across its facilities. This Performance Work Statement (PWS) outlines contractual requirements for the procurement, maintenance, training, and management of AEDs. In the near future, the FDA plans significant replacements of AED units and associated components to ensure optimal functionality. Contractors are required to supply FDA-approved biphasic AEDs with multiple safety specifications and maintain a robust training program for approximately 400 Site Coordinators. The scope of work includes proactive maintenance, technical support, and compliance with relevant health and safety standards. A structured evaluation process will identify proposals based on technical capabilities, past performance, and cost realism. The document emphasizes the FDA’s commitment to equipping and training personnel effectively to handle potential cardiac emergencies. Overall, the initiative underlines the critical importance of having lifesaving devices readily available and the necessity for ongoing professional training, adequate maintenance, and speedy response systems to enhance public safety across FDA facilities nationwide.

The document addresses vendor questions regarding an Automated External Defibrillator (AED) solicitation. Key clarifications include the continued requirement for on-site services despite cellular self-reporting capabilities, the mandatory use of Archibus software for device management, and the FDA's specific requirement for two Pad-Paks/batteries per deployed AED unit (one primary and one secondary backup). The FDA will not accept a vendor-based web software in place of Archibus. These responses aim to clarify service expectations, software requirements, and equipment configuration for potential vendors.

This Performance Work Statement (PWS) outlines the requirements for the FDA's Public Access Defibrillation (PAD) Program, focusing on the purchase, maintenance, training, and management of Automated External Defibrillator (AED) units across FDA facilities nationwide. The program currently manages approximately 399 AED units across 87 cities in 34 states. The contract includes a base year and two option years, detailing the replacement of AED units and components, proactive maintenance, CPR/AED training and certification for up to 500 students annually, 24/7 technical support, and post-event data retrieval. The contractor will also be responsible for managing the AED Site Coordinator list and ensuring compliance with industry and regulatory standards. The FDA will provide government-furnished property, such as PIV cards and laptops, and access to internal tracking systems like Archibus. Performance will be monitored through various quality assurance methods, with deliverables including AED unit replacements, maintenance reports, training certifications, and transition documentation.

The U.S. Food and Drug Administration (FDA) is soliciting proposals (RFQ: OC-2025-130285) for a total small business set-aside to procure, deliver, install, maintain, and support Automated External Defibrillator (AED) units for its nationwide Public Access Defibrillation (PAD) Program. The requirement includes approximately 400 FDA-approved biphasic escalating waveform AED units with real-time CPR feedback and self-diagnostic capabilities, integrated PAD PAK cartridges, responder kits, storage cabinets, signage, and inspection tags. The contract also mandates ongoing preventive maintenance, monitoring, 24/7 technical support, post-event data retrieval, and annual CPR/AED training for up to 500 FDA personnel across 87 cities in 34 states and U.S. territories. The period of performance is a 12-month base with two 12-month options. Proposals are due by September 24, 2025, 12:00 PM ET, and will be evaluated based on technical capability, corporate experience, management approach, and price.

The document provides a detailed inventory of AED devices and their components, including AED Primary PADs, AED Secondary PADs, and AED Pediatric PADs, with their corresponding expiration dates and projected replacement costs. The file lists 134 unique AED devices (911AED000001 to 911AED000137, with some numbers skipped), each with an associated equipment code and serial number. The expiration dates for the devices range from October 2026 to October 2030, while the expiration dates for the AED pads are more varied, with many expiring in June 2024, November 2024, September 2026, and a few in May 2026, October 2025, December 2022, November 2023, December 2023, January 2028, and August 2024. A total of 399 devices, 399 primary pads, 391 secondary pads, and 2 pediatric pads are listed, with a total count of 1191 items. The document indicates that some secondary pads have an "UNKNOWN" expiration date.

The Attachment A - PRICING SHEET outlines the costs associated with AEDs, maintenance, and training over a base period and two option years. Key items include Primary, Secondary, and Pediatric PAD-PAKs & Batteries, AED Maintenance & Monitoring, optional cabinets and signage, Technical and Program Management Support, and CPR/AED Training & Certification. Option Year 2 also includes AED Unit Replacement and Transition and Close-out services. The document details quantities and unit prices (all listed as $0.00 in this version) for each item, demonstrating a comprehensive plan for AED program implementation and sustainment.

The provided document is a template, version 4.2, titled “AED Solicitation – Vendor Pre Proposal Questions Template,” dated September 4, 2025. It is designed to facilitate vendor inquiries regarding solicitations, likely within the context of government RFPs, federal grants, or state/local RFPs. The template includes fields for Solicitation No., Solicitation Title, Question No., Question Type, Document/Part, PWS Section (§), POC (Email/Phone), Question, Suggested Correction/Clarification (optional), Priority, Attachment/File Name (optional), and Notes (optional). Users are instructed to open the template in Excel for full functionality, as some viewers may not show dropdown menus for selecting options within certain cells.

The FDA's Performance Work Statement (PWS) outlines the scope of services for its Public Access Defibrillation (PAD) Program, focusing on the purchase, maintenance, certified training, and management of Automated External Defibrillator (AED) units nationwide. The program currently manages approximately 399 AEDs across 87 cities in 34 states. The contract requires the replacement of a significant portion of these units and associated components over a base year and an option year, along with ongoing maintenance, technical support, and comprehensive CPR/AED training for up to 500 FDA employees annually. The contractor must meet industry, FDA, AHA, OSHA, and DOT standards. Key deliverables include AED unit replacement, maintenance, training, site coordinator list management, technical support, and post-event data retrieval. The FDA will provide government-furnished property like PIV cards and laptops, and access to internal tracking systems (Archibus). Performance will be monitored through various quality assurance methods, with the period of performance spanning a 12-month base and two 12-month option periods.