Debate and Provocations: Who Cleans Up After Failed Implants?

Prof. Maria Keet gave a presentation on computer ethics at an EthicsLab meeting, drawing from her new book, Autonomous Decisions. As someone interested in medical devices but still relatively new to ethics, I found her presentation particularly engaging. I was especially intrigued when she discussed implants and software, as my research focuses on the regulatory journey of medical devices, such as implants, from conception to clinical trials in humans.

The Role of Software in Medical Implants

Not all implants function the same way. Some, like hip replacements, are purely mechanical and require no software. Hip implants are medical devices designed to replace a damaged hip joint, helping people move more easily and reducing pain, particularly for those with arthritis or hip injuries.

In contrast, other implants, such as pacemakers, rely heavily on software. A pacemaker is a small device that regulates abnormal heartbeats by sending electrical signals to maintain a normal heart rate and rhythm. A pacemaker is a small device that helps regulate abnormal heartbeats by sending electrical signals to maintain a normal heart rate and rhythm. In a pacemaker, the software plays a critical role in managing its functions; setting the lowest allowable heart rate, adjusting the device's response to different heart conditions, and using sensor data to modify the heart rate based on physical activity or other bodily changes. Without continuous software support in such devices, they can become ineffective or even dangerous.

The Problem: What Happens When a Company Shuts Down?

Prof. Keet raised a critical question I hadn’t considered:

“Service Level Agreements are time limited. What is an appropriate timespan for the hardware and software of implants, and who is ultimately responsible for ensuring continued support?”

Imagine this scenario: A company develops and maintains pacemaker software, but after deployment in an experimental study, the company shuts down or goes bankrupt. What happens to the software embedded in the device? How long will it continue to function safely and effectively?

A Service Level Agreement (SLA) is a contract that defines the level of service a company must provide to its customers, including how long support will be available. But what happens if the company ceases operations? Who takes responsibility for maintaining the service? What happens to the agreement, and how should it be enforced?

A Real-World Example: Markus Möllmann-Bohle

This dilemma isn’t just theoretical—it has already happened.

Since 2013, Markus Möllmann-Bohle has relied on a neurostimulator implanted under his cheekbone to manage severe cluster headaches. The device sends small electrical pulses to block pain signals from his nerves. However, in 2019, the manufacturer shut down, leaving Möllmann-Bohle and hundreds of other patients stranded without access to the proprietary software needed to adjust their implants and keep them working properly.

Because of his background as an electrical engineer, Möllmann-Bohle has managed to continue using the device and carrying out some maintenance himself. But this isn’t a sustainable solution. The implant requires advanced maintenance, and without proper support, its future remains uncertain.

So, who should have been responsible for ensuring the continued upkeep of his implant? And how do we prevent this from happening again?

Beyond This Case, Similar Concerns Arise:

• Who is responsible for software updates, security patches, and fixing malfunctions when the responsible company goes out of business?
• If a software failure harms a patient, who bears legal and ethical responsibility—the manufacturer, the healthcare provider, or another entity?
• If an implant fails due to software issues, who pays for removal or replacement? If the state funded the implantation, should it also be responsible for long-term monitoring, software failure costs, and continued patient care?
• What legal and regulatory measures are needed to ensure that implantable medical software remains supported, even after the original developer shuts down?

At the heart of this issue are real people whose health and quality of life depend on medical devices. Should we accept that some patients will be abandoned when companies fail, or do we have a moral obligation to create safeguards? If we fail to act, how many more will face Möllmann-Bohle’s dilemma?

Edited using ChatGPT free version with the following prompt: Please proofread, fix punctuation and improve the structure to enhance readability