Baxa's Non-Approved Software Policy: That's Your Problem

While browsing the web for medical devices that appear to run on Windows operating systems, I came across the Baxa ExactaMix Compounder. One could use a compounder for parenteral nutrition. These devices do run a "Microsoft Operating System" according to Baxa. Interestingly, the product page contains a link to a Baxa-authored whitepaper titled Preventing Cyber Attacks (PDF). At first glance, I was pleased to see that Baxa actually offers guidance on this issue, but the content of the whitepaper raises alarms. This excerpt in particular is unsettling (my emphasis added):

FDA regulations require manufacturers to “Validate all changes, updates, and patches, including operating systems, before installing them to ensure the safety and effectiveness of the medical devices.”1 Baxa ExactaMix Compounders have been verified and validated only with the software that was installed by Baxa. Thus, any changes to the original, validated image, including installation of antivirus software, nullifies the validated state, may create an unsafe operating condition, and would constitute off‐label use. 

As an FDA‐regulated manufacturer, Baxa Corporation will not/cannot support nor endorse off‐label use of its compounder. Only validated systems are approved by Baxa as being safe and effective for use. Any unauthorized programs installed on a Baxa product will void the manufacturer’s warranty. ExactaMix Compounders have been validated only with the operating system and patches installed by Baxa. Installing any software not provided by Baxa, including OS updates, firewall software and anti‐virus products, on Baxa automated compounding devices may change the operating parameters and adversely affect the operation of the device, rendering it unsafe to use. 

The footnote above points to an FDA document titled Reminder from FDA: Cybersecurity for Networked Medical Devices is a Shared Responsibility, of which Baxa has adopted a very narrow interpretation that maximally reduces their responsibility for software security.  How convenient.

While the quote that Baxa pulled from the document is really there, it does not tell the whole story. Rather than taking the draconian stance on the issue of software configuration that Baxa suggests, the document also explicitly states that, "Medical device manufacturers and user facilities should work together to ensure that cybersecurity threats are addressed in a timely manner." and furthermore that:

The need to be alert and responsive to cybersecurity issues is part of the device manufacturer’s obligation...Software patches and updates are essential to the continued safe and effective performance of medical devices. Typically, FDA approval is not required before install changes, updates, or patches that address cybersecurity issues (see question #10 of the guidance).

Other highlights from the FDA document include these two bullet points that appear to directly contradict Baxa's stance on software updates:

• Make sure that you have adequate anti-virus software and firewalls installed, properly set up and current.

• Update your operating system and medical device software. Software updates offer the latest protection against harmful activities.

In fairness to Baxa, the FDA guidance does not make it entirely clear what the company's responsibilities are in terms of validation for software updates and antivirus software, but a blanket mandate that customers must not take vital steps to protect their devices or patients seems like an irresponsible choice by a manufacturer that could put patients at risk. Rather than sharing responsibility as FDA recommends, Baxa is completely abdicating responsibility for security and forcing customers to do the same by forbidding them to install software updates.

Click Here to Download Your AVEA Ventilator Software Update. Trust Me.

[Updates contributed from readers appear at the bottom of this blog post.]

Summary: The web server distributing the software updates for a ventilator (a medical device) itself needs some help with software updates. According to Google, the web server was infected with 48 viruses and 2 scripting exploits. 20 pages resulted in malicious software being downloaded and installed without user consent. 

The risks should be obvious. This is an update for a medical device, and yet one must download it in a manner as if software sepsis is no big deal. Health care professionals might as well stop their washing hands while they're at it.

Hospital IT staff:  How much do you trust the Internet for updating medical device software? A number of researchers in software upgrades bemoan the general state of the art for secure software updates.  Worse, the cryptographic technology at the core of commercial software update mechanisms is broken and being actively exploited by the Flame virus.

Well, if you work for a hospital, the Flame virus is probably the least of your worries.  You just want to keep your HIT systems and software-controlled medical devices working.  Vendors routinely install software updates for medical devices from the Internet or USB keys.  I've seen medical sales engineers download pacemaker-related software from the Internet.

Today I tried to download a software update for CareFusion AVEA Ventilators.  What I found may disturb hospital IT staff.  Here's a screenshot.  When I clicked on the highlighted link for "AVEA Ventilator software update," a second dialog box popped up, "Warning: Visiting this site may harm your computer."

What's this second dialog box?  It's a feature in the web browser that uses the Google Safe Browsing service.  For this particular web server that provides the software update for a ventilator, Google had the following data for www.viasyshealthcare.com:

What happened when Google visited this site?Of the 347 pages we tested on the site over the past 90 days, 20 page(s) resulted in malicious software being downloaded and installed without user consent. The last time Google visited this site was on 2012-06-08, and the last time suspicious content was found on this site was on 2012-06-03.
Malicious software includes 48 trojan(s), 2 scripting exploit(s).
Malicious software is hosted on 3 domain(s), including nikjju.com/, lilupophilupop.com/, koklik.com/.
This site was hosted on 1 network(s) including AS26651 (CAREFUSION).

Wonderful.  I am downloading ventilator software from a web server known to have 48 trojans and 2 scripting exploits.  Hurray for science and technology.  Clicking on the CAREFUSION link provides further assuring data:

What happened when Google visited sites hosted on this network?
Of the 3 site(s) we tested on this network over the past 90 days, 2 site(s), including, for example, viasyshealthcare.com/, sensormedics.com/, served content that resulted in malicious software being downloaded and installed without user consent.
The last time Google tested a site on this network was on 2012-06-08, and the last time suspicious content was found was on 2012-06-06.

On the same site, I found another product that discusses its software update mechanism for Cortical Stimulator Control Units.  The company advises its customers to "Click Run" when the "File Download Security Warning" dialog box appears.  The instructions appear to refer to a CD rather than an Internet download, but I wonder how many technicians take a short cut by downloading an update via the Internet.  That Internet is so darn convenient.

I find it difficult to establish trust in the safety of software affilatied with reports of "malicious software being downloaded and installed without user consent."

What's the way forward?  That's a longer discussion.  Let me update you over drinks.  For starters, go read the Google papers on web malware [Trends in Circumventing Web-Malware Detection and All Your iFRAMEs Point to Us].  Here's to a better and more secure software update infrastructure.  Cheers.

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