End-of-Life Medical Device Security Risks
Post Summary
End-of-life (EOL) medical devices are a growing cybersecurity concern for healthcare organizations. These devices, no longer supported by manufacturers with updates or patches, expose hospitals to risks like data breaches, operational disruptions, and patient safety issues. With healthcare breaches costing an average of $11 million in 2023, addressing EOL vulnerabilities is critical.
Key Takeaways:
- EOL vs. EOS: EOL devices may still get limited support, while EOS devices receive no updates or patches, leaving them highly vulnerable.
- Common Risks: Outdated systems, weak authentication, unencrypted data, and reliance on obsolete protocols.
- Impacts: Data breaches, regulatory fines, legal liabilities, and potential harm to patients.
- Solutions:
- Conduct regular risk assessments.
- Use network segmentation to isolate vulnerable devices.
- Plan for device replacements or secure decommissioning.
- Collaborate with vendors for clear security documentation.
Healthcare organizations must act promptly to manage these risks, safeguard patient data, and ensure uninterrupted care.
End-of-Life Medical Device Security Statistics and Impact
Security Risks of End-of-Life Medical Devices
Common Vulnerabilities in EOL Medical Devices
End-of-life (EOL) medical devices come with a host of vulnerabilities that make them prime targets for cyberattacks. A staggering 59.8% of all medical device vulnerabilities arise from issues like weak user authentication and flawed software code [5]. Many of these problems stem from default or easily guessed credentials, which can expose sensitive patient data, or from software defects that leave systems open to crashes and exploits.
Another alarming trend is the reliance on outdated third-party libraries, which often lack proper update mechanisms. This has led to a 386% surge in security advisories since 2016 [5]. Interestingly, just four major vendors - Baxter, BD, Medtronic, and Philips - accounted for nearly half of these vulnerabilities (200 out of 433) [5].
"Legacy medical devices often remain in use long after their operating systems, firmware, and security protections have become outdated... With the right approach, legacy doesn't have to mean liability." - Med Device Online [3]
Updating these devices is no small task. Even minor security patches can require expensive retesting and regulatory approvals, discouraging manufacturers from acting quickly [3]. On top of that, healthcare providers often lack a comprehensive inventory of their devices, leaving them unaware of the specific risks tied to older equipment [3]. Despite new regulatory efforts to encourage timely updates, patch references in vulnerability disclosures actually dropped by 22% in 2024 [5].
These vulnerabilities make it increasingly difficult to integrate EOL devices into modern healthcare networks.
Integration Problems with Modern Networks
EOL devices don’t just pose security risks - they also struggle to function within modern IT environments. Many of these aging devices lack support for essential security features like data encryption, advanced access controls, or Software Bill of Materials (SBOM) documentation [3]. When connected to contemporary networks, they often act as weak links, providing attackers with potential entry points to compromise broader systems.
Another challenge is simply identifying these devices. Healthcare organizations frequently don’t have a clear understanding of which legacy devices are still connected to their networks or what risks they bring [3].
"Cybersecurity risk management is a shared responsibility among stakeholders including the medical device manufacturer, the user, the Information Technology (IT) system integrator, Health IT developers, and an array of IT vendors." - FDA [4]
Effects on Compliance and Patient Safety
The risks of EOL devices extend far beyond technical flaws, impacting both regulatory compliance and patient safety. A striking 73% of healthcare providers still depend on medical devices running outdated or unsupported systems [6]. This reliance exposes them to potential HIPAA violations, especially when insecure devices lead to unauthorized data access. The financial toll is immense - on average, healthcare data breaches cost $4.35 million as of 2022 [7].
But the stakes are even higher when it comes to patient safety. Vulnerabilities in critical devices such as pacemakers, insulin pumps, and infusion pumps can lead to catastrophic outcomes, including erratic device behavior, incorrect medication dosages, or even total device failure [1][7]. Ransomware attacks targeting unpatched EOL devices can disrupt essential hospital operations, delaying treatments and emergency services [6][1]. Compromised devices like diagnostic imaging systems or vital sign monitors can produce manipulated data, leading to potentially life-threatening clinical decisions [1][7].
Regulatory penalties further compound the issue. Non-compliance with standards such as the EU Medical Device Regulation (MDR) or FDA post-market surveillance requirements can result in hefty fines or even the loss of operational rights for certain equipment [1][3]. Continued use of unsupported devices also increases legal liability for healthcare providers if a security breach causes harm to patients [3].
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Threats and Consequences
How Attackers Exploit EOL Device Vulnerabilities
Outdated medical devices don’t just pose risks to themselves - they jeopardize entire healthcare networks. Cybercriminals exploit vulnerabilities in end-of-life (EOL) medical devices using various methods, turning these devices into entry points for larger attacks. For instance, remote code execution attacks involve sending malicious network requests to take over a device. Once compromised, attackers can use these devices to move laterally across a hospital's network, exposing other connected systems to risk[4].
Another common method is the man-in-the-middle attack, where attackers exploit weak or unauthenticated network protocols. This allows them to intercept and manipulate device communications, which could result in altered medication delivery data or the theft of sensitive patient information[9]. Many outdated devices also transmit unencrypted patient data to fixed IP addresses, making it easy for anyone monitoring the network to intercept confidential health records[8].
Physical access to these devices adds another layer of vulnerability. Attackers with direct access can extract stored Wi-Fi credentials or intercept unencrypted data exchanged within the device. They may also launch denial-of-service attacks, crashing devices and disrupting patient care.
"An exploit is an instance where a vulnerability or vulnerabilities have been exercised (accidentally or intentionally) by a threat and could impact the safety or essential performance of a medical device or use a medical device as a vector to compromise a connected device or system." – FDA [4]
These exploitation methods aren’t just theoretical - they’ve led to real-world breaches, as the following examples demonstrate.
Case Studies
In February 2025, both CISA and the FDA issued emergency advisories for the Contec Health CMS8000 Patient Monitor due to multiple critical vulnerabilities (CVE-2024-12248, CVE-2025-0626, CVE-2025-0683). The device had a CVSS v4 score of 9.3 and was found transmitting unencrypted patient data to a hard-coded public IP address (202.114.4.119). These flaws allowed attackers to remotely execute code with minimal effort, creating a high risk for widespread exploitation in shared hospital networks. As a result, the FDA strongly urged healthcare providers to remove these devices entirely from their systems[8].
Another incident occurred in September 2022, when researchers uncovered severe vulnerabilities in Baxter SIGMA Spectrum Infusion Pumps (Firmware 8.00.01) and their Wi-Fi battery units. One flaw (CVE-2022-26390) involved storing Wi-Fi credentials in non-volatile memory, meaning sensitive information remained accessible even after the device was powered off. Another issue (CVE-2022-26394) allowed unauthenticated remote reconfiguration of gateway IP addresses via XML commands on TCP/UDP port 51243. This made the devices susceptible to man-in-the-middle attacks, enabling attackers to intercept and manipulate medication delivery data[9].
These examples highlight the far-reaching impact of such vulnerabilities, which extend beyond technical breaches to include legal and financial fallout.
Regulatory and Financial Consequences
The consequences of ignoring vulnerabilities in EOL devices extend well beyond cybersecurity concerns. Healthcare organizations can face hefty penalties under HIPAA if insecure devices lead to unauthorized access to Protected Health Information (PHI). The FDA’s Quality Management System Regulation (QMSR), aligned with ISO 13485:2016 and effective February 2, 2026, also enforces stricter safety standards for medical devices[4].
Manufacturers are required to report device corrections and removals that pose health risks under 21 CFR part 806. Additionally, any incidents involving death or serious injury must be reported under the Medical Device Reporting requirements outlined in 21 CFR part 803[4]. The FDA refers to the continued use of devices with unresolved cybersecurity risks as an "uncontrolled risk", where the potential for patient harm is deemed unacceptable[4].
"Failure to maintain cybersecurity can result in compromised device functionality, loss of data (medical or personal) availability or integrity, or exposure of other connected devices or networks to security threats. This in turn may have the potential to result in patient illness, injury or death." – FDA [4]
Beyond regulatory penalties, security breaches can lead to lawsuits, reputational damage, and operational disruptions. In the healthcare industry, where multiple parties - manufacturers, providers, IT integrators, and vendors - share responsibility, the liability for these vulnerabilities can ripple across the entire ecosystem, increasing third-party risk for all stakeholders[4].
How to Reduce End-of-Life Device Security Risks
Regular Risk Assessments and Monitoring
Start by identifying all legacy devices, noting their locations and connectivity, and then evaluate their risks. This process should consider technical feasibility, regulatory requirements, and clinical impact. Collaboration between manufacturers and healthcare providers is crucial during these evaluations. Key considerations include the possibility of security updates, encryption strength, access controls, the availability of a Software Bill of Materials (SBOM), and current monitoring practices. To ensure compliance and safety, align these assessments with established frameworks such as those from the FDA, NIST, ISO, and IMDRF.
"Healthcare Delivery Organizations should perform more regular risk assessments going into End of Life and End of Support to determine if they can accept the risk of continued use." – Health-ISAC [2]
Focus on devices that are network-connected or critical for life-sustaining functions. When technical updates are no longer an option, continuous monitoring can help detect and address vulnerabilities in real time. Tools like Censinet RiskOps™ simplify this process by automating workflows and centralizing visibility into device risks. This approach ensures organizations can maintain thorough documentation and establish effective procedures for managing legacy devices. Once risks are identified, the next step is implementing technical safeguards.
Technical Safeguards for EOL Devices
If replacing end-of-life (EOL) devices immediately isn’t possible, implementing technical safeguards is essential. One effective method is network segmentation, which isolates vulnerable devices from the main hospital network. This strategy limits an attacker’s ability to move through the system if a device is compromised, reducing the overall risk while allowing the device to remain in use for patient care.
As devices approach the end of their lifecycle, the responsibility for maintaining security shifts more heavily onto the healthcare delivery organization. Meanwhile, manufacturers should design devices with security in mind, adhering to principles like "Secure by Design, Secure by Default, and Secure by Demand" [2]. Even after deployment, post-market updates and requirements remain crucial, as cybersecurity risks continue to evolve [2].
"Communication between the two parties is essential as the device moves through the lifecycle so that tasks are coordinated, and security gaps within the product are reduced." – Health-ISAC [2]
Transparency plays a key role here. Detailed security documentation and a comprehensive SBOM help healthcare organizations identify potential vulnerabilities and manage updates effectively. Based on risk assessments, organizations can choose to address issues with secure updates, enhance monitoring, or document and contain risks for lower-priority systems.
Working with Third-Party Vendors and Planning Upgrades
Managing legacy risks effectively also requires strong collaboration with vendors. Maintain a detailed inventory of device security data, including encryption status and whether protected health information (PHI) is stored. Using tools like a Computerized Maintenance Management System (CMMS) or similar databases can simplify this process. Standardized documents such as the Manufacturer Disclosure Statement for Medical Device Security (MDS2) and the SBOM provide essential insights into a device’s security features.
Establishing Information Sharing Agreements (ISAs) with manufacturers can clarify expectations and improve transparency when managing legacy device risks. Before a device reaches its end of life, request a list of all locations where data is stored, including any cloud-based systems, and ask for guidance on the most secure methods for data removal. Formalize decommissioning procedures with clear documentation on data storage and approved data-wiping methods.
"Creating a structured decommissioning process now will help assure that the protections you need are in place when you dispose of medical devices in the future." – Chad Waters, Senior Cybersecurity Engineer, ECRI [10]
During the decommissioning process, disassociate devices from management servers or cloud services to block unauthorized network access. Remove all IT configurations, such as IP addresses, wireless settings, and Active Directory accounts. Additionally, secure documentation from third-party salvage companies confirming that storage media has been destroyed. Modular designs can also extend the secure lifecycle of devices by allowing component upgrades when full replacement isn’t feasible.
Building an End-of-Life Device Management Plan
Core Elements of an EOL Management Plan
A solid end-of-life (EOL) management plan starts with maintaining an accurate inventory. This inventory, ideally stored in a Computerized Maintenance Management System (CMMS) or a configuration management database, should focus on tracking devices that handle Protected Health Information (PHI) [10]. Use tools like MDS2 and SBOM to monitor device security details and identify vulnerabilities [10][12].
As devices approach EOL or End of Support (EOS), ramp up risk assessments to keep safety in check [2]. These assessments should move beyond traditional probability models and incorporate exploitability metrics. Why? Because cybersecurity threats stem from human behavior, making them harder to predict using standard methods [12]. A thorough vulnerability management plan should include processes for coordinated vulnerability disclosure, regular security testing, and clear timelines for patch development and deployment [12].
"Cybersecurity risk management is a shared responsibility among stakeholders including the medical device manufacturer, the user, the Information Technology (IT) system integrator, Health IT developers, and an array of IT vendors." – FDA [4]
As discussed earlier, the responsibility for cybersecurity shifts to healthcare organizations after device deployment. This makes having robust decommissioning protocols essential. When devices leave your facility - whether they’re being destroyed, sold, or reassigned - establish clear data decommissioning procedures [10]. This involves requesting data-wiping utilities from manufacturers, manually disconnecting devices from servers or cloud services, and removing IT configurations like wireless settings, IP addresses, Active Directory accounts, and DICOM setups [10]. Remember, at the EOL stage, cybersecurity accountability lies with healthcare organizations [2][4].
Comparing Management Approaches
Choosing the right management strategy depends on the device's criticality, technical feasibility, and clinical importance. Here’s a breakdown of different approaches to mitigate vulnerabilities:
| Management Strategy | Cost Level | Implementation | Best Use Case |
|---|---|---|---|
| Remediation | High | Software/firmware updates and revalidation. | Critical care devices with vendor support [11]. |
| Compensating Controls | Moderate | Network segmentation, firewalls, access restrictions. | Legacy devices that are functional but not patchable [4]. |
| Containment | Low | Risk documentation and isolated monitoring. | Low-priority systems with minimal clinical impact [11]. |
| Decommissioning | Variable | Data wiping, factory resets, or physical destruction. | Devices at the end of their functional life [10]. |
For smaller or underfunded hospitals, mutual aid partnerships or private sector collaborations can help manage legacy devices by pooling costs and expertise [13]. Joining Information Sharing Analysis Organizations (ISAOs), like Health-ISAC, can also ease the burden. These groups allow members to share vulnerability assessments and receive actionable threat intelligence, reducing the strain on individual resources [4].
To implement these strategies effectively, consider leveraging advanced tools that streamline risk management.
Using Censinet RiskOps™ for EOL Management
Censinet RiskOps™ simplifies the process of managing EOL device risks with AI-powered automation, replacing slow, manual evaluations. This platform centralizes visibility into device risks across your healthcare organization, making it easier to identify which legacy devices need urgent attention and which can be managed with compensating controls.
The platform acts as a command center for risk management, offering a real-time dashboard that consolidates all device-related policies, risks, and tasks. With Censinet AI™, the platform speeds up assessments by summarizing vendor evidence, capturing integration details, identifying fourth-party risks, and generating risk summary reports. While automation handles much of the heavy lifting, human oversight ensures critical decisions remain in the right hands.
Censinet RiskOps™ also features advanced routing and orchestration tools, directing key findings and tasks to the appropriate stakeholders. This ensures that critical issues are addressed promptly and by the right teams, maintaining accountability and oversight throughout your organization.
Healthcare organizations can choose from three implementation models:
- Internal Use: Full access to risk assessment tools for in-house management.
- Hybrid Approach: A mix of software and managed services tailored to your needs.
- Fully Outsourced: Comprehensive cyber risk management, including assessments and reporting.
These options allow organizations to scale their risk management efforts effectively while staying aligned with their specific operational needs.
Into the Looking Glass, Medical Device Cybersecurity | Veronica Schmitt
Conclusion
End-of-life medical devices pose a serious challenge to healthcare cybersecurity. With hospitals averaging 10–15 connected devices per bed and breaches costing nearly $11 million in 2023, the need for proactive risk management is undeniable [1]. Older systems, especially those no longer supported, create vulnerable entry points to Electronic Health Records and other critical systems.
When manufacturers end support for these devices, the responsibility for their security shifts entirely to healthcare organizations [2]. This requires a proactive approach. Hospitals and clinics must maintain detailed inventories, conduct regular risk assessments, segment networks, and plan for phased replacements. As Daniel Bardenstein from Manifest Cyber highlights:
"EOL and EOS aren't just compliance checkboxes, they're fundamental cybersecurity and patient safety issues" [14].
Addressing these risks demands focused solutions. Tools like Censinet RiskOps™ simplify the process by centralizing device visibility, automating risk assessments, and coordinating remediation efforts across IT, Risk, Cybersecurity, and BioMed teams. With Censinet AI™, organizations can speed up evidence reviews and generate actionable plans, scaling their risk management efforts without compromising patient safety.
Timely action is essential. Before devices become obsolete, healthcare organizations should use a Software Bill of Materials to track component lifecycles, implement structured decommissioning protocols, and adopt automated platforms to stay ahead of potential threats. Consolidated risk assessments and clear decommissioning strategies are vital to protecting patient care. Whether managing risks internally, through a hybrid approach, or by outsourcing, the goal remains the same: safeguarding patient data and ensuring safe, reliable care in an increasingly connected healthcare system.
FAQs
How do I quickly find EOL/EOS devices on my network?
To spot EOL (End of Life) or EOS (End of Support) devices on your network quickly, leverage tools specifically built for device discovery and lifecycle management. Regular network scans using asset management and vulnerability assessment tools can pinpoint outdated hardware and software. These scans are especially useful for identifying unsupported devices, such as IoT gadgets or medical equipment, which can pose security risks. Establishing a clear EOL detection policy ensures you're managing these risks proactively and staying ahead of potential vulnerabilities.
When should an EOL device be replaced vs isolated?
When a device reaches its end-of-life (EOL), it’s time to assess its role in your setup. If the device no longer receives support, creates serious cybersecurity vulnerabilities, or doesn’t work with modern technology, it’s best to replace it. However, if the device still functions but lacks updates or support, you might consider isolating it. Just make sure strong security measures are in place to minimize any risks.
What’s the safest way to decommission an EOL device?
The best approach to safely decommission an end-of-life (EOL) medical device involves a clear, step-by-step process to protect sensitive data and ensure proper handling. Begin by securely erasing or physically destroying any data stored on the device, especially protected health information (PHI). Use approved methods for data sanitization, or opt for physical destruction when necessary to eliminate all risks. Lastly, document every step of the process thoroughly to stay compliant with regulations and minimize potential cybersecurity threats tied to decommissioned devices.
