Service manuals aren’t optional or proprietary “extras” in a hospital. They’re required for safe maintenance and compliance, and they should be non-negotiable at purchase.
By J. Scot Mackeil, CBET – senior anesthesia BMET, Massachusetts General Hospital
In the fast‑paced and high‑stakes environment of a modern hospital, a service manual is far more than a technical reference. It is the DNA of the medical device lifecycle. These documents are the foundation that tells a biomedical equipment technician (BMET) exactly how a device is supposed to work, how it fails, and how to keep it safe for patients.
Some manufacturers may still view service manuals as proprietary assets tied to their service revenue, but within healthcare technology management (HTM) departments, these manuals are nothing less than mission‑critical infrastructure. They enable BMETs to keep life‑support equipment running, ensure clinical uptime, reduce risk, protect patients, and meet strict regulatory requirements that govern nearly every aspect of hospital operations.
A Lifecycle Tool, Not Just a Repair Guide
The utility of a service manual begins long before a device reaches a patient’s bedside and continues long after it has left front‑line clinical service. These documents guide the earliest stages of evaluation, procurement, and installation, shape how a device is tested and configured during incoming inspection, and provide the foundation for safe day‑to‑day operation throughout its clinical lifetime.
Even after retirement, the manual remains vital for proper decommissioning and donations, ensuring that the device’s final steps are handled with the same level of safety and precision as its first patient day.
Pre‑Purchase, Procurement, and Incoming Inspection
Clinical engineers use service manuals to evaluate their department’s future needs to sustain the device, evaluate IT security requirements, risk management factors, installation needs, and the device’s suitability for intended use.
BMETs rely on service manuals to familiarize themselves with a device’s technical design, specifications, and operating principles. These documents will guide required acceptance testing, proper assembly and installation, configuration, and fine‑tuning of system settings, and verification that the device is safely integrated into the hospital’s equipment inventory.
Point of Care Support
When a device fails at the bedside, the service manual becomes indispensable, providing real‑time troubleshooting information essential for swift, accurate intervention. A patient’s outcome can be severely affected by a technology failure, and both the BMET and the physician need every possible advantage to mitigate the issue quickly and safely.
Having immediate access to the manufacturer’s documented procedures gives the BMET the technical footing required to restore function, support the clinical team, and prevent a device malfunction from escalating into a patient‑care crisis.
Planned Maintenance (PM)
Service manuals serve as authoritative sources for PM checklist development and for designing alternative equipment maintenance (AEM) strategies.
Forensic Device Investigations
During adverse incident reviews, service manuals support failure modes and effects analysis and provide the technical foundation for regulatory reporting to the US Food and Drug Administration (FDA), ECRI, or hospital risk management.
The Regulatory Imperative
Access to service manuals is not optional; it is a regulatory requirement. In the United States, US Centers for Medicare & Medicaid Services (CMS), Joint Commission, FDA, and the National Fire Protection Association (NFPA) all set clear expectations for manufacturers and healthcare organizations.
CMS mandates that repairs and PM activities follow original equipment manufacturer (OEM) procedures found in service manuals.
Joint Commission standard EC.01.01.01, EP 3 requires accredited healthcare facilities to maintain a comprehensive library of service information. (HTM professionals may recall George Mills announcing this initiative at the 2018 AAMI Conference in Long Beach.)
NFPA 99-2012, the US National Health Care Facilities Code, requires manufacturers to provide the service documentation necessary to support safe equipment operation and lifecycle management. Essential maintenance information cannot be withheld under claims of confidentiality.
NFPA-99-2012 Section 10.5.3.1.1 states that the manufacturer of the device shall furnish operator’s, maintenance, and repair manuals with all units. These shall include operating instructions, maintenance details, and testing procedures.
As for FDA regulations, “Under 21 CFR 820.40 and 820.181, manufacturers are federally required to control and maintain servicing instructions within the Device Master Record, ensuring that complete and accurate service documentation exists to support safe installation, maintenance, and repair throughout the device’s lifecycle.”
Operational Excellence and Integrity
A BMET’s ability to perform real‑time troubleshooting is fundamental to keeping clinical services running. As OEMs reduce direct technical support in favor of tape gun service models or place technical support calls behind paywalls, the service manual becomes the BMET’s most reliable tool for restoring device function quickly—directly influencing patient safety and care continuity.
Likewise, during forensic device investigations, the service manual provides the technical grounding required to generate accurate, defensible findings for hospital risk management.
BMETs rely on service manuals not only for repairs and PMs, but also for incoming inspections, configuration, and gaining essential familiarity with a device’s design and functions. When a BMET signs a PM label, completes a repair report, or conducts a forensic device investigation, their professional credibility is anchored in the fact that their actions were guided by documented, manufacturer-supplied procedures. The service manual is the foundation that ensures the BMET’s technical decisions are traceable, defensible, and aligned with regulatory expectations.
On the other hand, the absence of service manuals exposes both BMETs and OEMs to significant liability. Without documented procedures to reference, BMETs are forced to rely on incomplete information, tribal knowledge, or guesswork—conditions that increase the risk of improper repairs, missed safety checks, and undetected failure modes.
If an adverse event occurs and a BMET cannot demonstrate that their actions followed manufacturer-based procedures, both their professional credibility and the hospital’s defense in a legal or regulatory investigation may be compromised.
Likewise, OEMs face heightened risk. Withholding service documentation can be interpreted as obstructing hospital policies and maintenance practices, violating NFPA 99‑2012 expectations, and contributing to unsafe conditions that expose the manufacturer to legal scrutiny. In short, when manuals are unavailable, everyone carries more risk—the hospital, the BMET, the OEM, and ultimately, the patient.
Strategic Integration: From Procurement to Deployment
The value of a service manual begins during pre‑purchase evaluation. Clinical engineers and value analysis teams rely on this information to:
- review cybersecurity requirements,
- assess interoperability and systems risk,
- understand maintenance needs, and
- calculate the true total cost of ownership, including projected service workloads.
End‑of‑Life Philanthropy
For equipment donated to global health partners, the service manual ensures the device does not become e‑waste. It enables technicians in developing nations to install, repair, and maintain the equipment safely, extending its useful life and continuing its mission of patient care long after retirement from US hospitals.
A Call to Action for HTM and CE Leadership
The fight for service manual access must be won during procurement—not after the purchase order is signed. Clinical engineering leaders must insist, as part of the request for proposal process, that OEMs provide:
- Complete, unredacted service manuals
- Schematics
- Parts lists
- Diagnostic software
- Diagnostic access codes
- Access to repair parts
- Training resources
These should be non‑negotiable line items in every request for proposal and purchase order. By leveraging purchasing power early, leadership ensures BMETs have the tools needed at the workbench from day one.
I would also say that HTM managers should empower their BMETs to say “no” to doing incoming inspections on devices unless the service manual accompanies the request. Protecting the “right to repair” begins at the negotiating table and safeguards the hospital’s long‑term investment in essential technology.
Open Access Is a Shared Safeguard
Strengthening the partnership between OEMs and hospitals requires open access to service manuals, parts, software, access codes, and training. When manufacturers empower HTM professionals with the documentation and tools needed to maintain devices safely and effectively, they become true allies in healthcare delivery—ensuring that lifesaving technology remains safe, compliant, and ready for the next patient.
Conversely, restricting access to service information introduces avoidable risk for everyone involved. Without proper documentation, BMETs face increased liability if maintenance actions cannot be traced back to manufacturer‑approved procedures, and OEMs expose themselves to regulatory and legal scrutiny for withholding information essential to safe operation as defined by NFPA 99 and CMS expectations. Open documentation is not just good practice; it is a shared safeguard that protects the patient, the hospital, the BMET, and the manufacturer alike.
About the Author: J. Scot Mackeil, CBET, is a senior biomedical equipment technician at Mass General Hospital in Boston with over 45 years of experience. He is a 2018 GE/AAMI BMET of the Year recipient and a frequent contributor to HTM publications and symposiums. He specializes in anesthesia, neuromonitoring, and surgical systems. He is a General Class Ham Radio license holder – N1JSM.
Key Sources
- Centers for Medicare & Medicaid Services (CMS). State Operations Manual: Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals. CMS; Rev. 202.
(Requirements for following manufacturer maintenance recommendations.) - The Joint Commission. Comprehensive Accreditation Manual for Hospitals (CAMH): Environment of Care Standard EC.01.01.01, EP 3. Oakbrook Terrace, IL; latest edition.
(Mandates availability of service information and maintenance documentation.) - Mills, George. Announcement on service documentation requirements. Presented at: AAMI Annual Conference & Expo; 2018; Long Beach, CA.
(Historical introduction of the new EP addressing service manual availability.) - National Fire Protection Association. NFPA 99: Health Care Facilities Code. 2012 Edition. Quincy, MA: NFPA.
(Defines manufacturer obligations for providing documentation necessary for safe operation and maintenance.) - US Food and Drug Administration. 21 CFR §820.40 – Document Controls.
(Requires manufacturers to control all documents, including service instructions and specifications needed for safe maintenance.) - US Food and Drug Administration. 21 CFR §820.181 – Device Master Record (DMR).
(DMR must include all documentation needed to manufacture, install, test, maintain, and service the device.) - Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI EQ56: Recommended Practice for a Medical Equipment Management Program.
(Defines maintenance strategies, including AEM methodology.) - AAMI. AAMI TIR18: Guidance on Planning and Implementing a Medical Device Preventive Maintenance Program.
(Framework for PM development and documentation‑based procedures.) - Federal Trade Commission. Nixing the Fix: An FTC Report to Congress on Repair Restrictions. May 2021.
(Analyzes OEM repair restrictions and their impact on safety, competition, and access to servicing information.)
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