Interoperability – Barriers to Adoption
There’s been some great comments on the recent post about the announcement of MD FIRE. That plus some other activities I’ve been involved in have inspired some thoughts on barriers to adoption for medical device interoperability.
For this discussion, interoperability refers to the ability of a medical device to be controlled by another medical device or third party information system. Medical device systems from a single vendor frequently include interoperability between the medical devices and applications running on general purpose computers, but since all the components are from the same vendor I’m excluding them from this discussion.
Like everything else, medical device interoperability will walk before it runs. In a recent comment, JimW suggests that MD FIRE’s focus is on driving the adoption of, “tightly coupled, low latency, deterministic connection[s].” I beg to differ; I found the MD FIRE text to be very general and that it avoided any kind of design solution whatsoever. Further, it is interesting that what little multi vendor interoperability that is actually on the market, is based on “tightly coupled, low latency, deterministic connection[s].” The example that comes to mind (actually the only one I can think of right now) is the use of CANopen to integrate radiographic equipment with contrast injectors in diagnostic imaging. Perhaps someone can provide additional examples.
Jim is right that such interoperability presents considerable product design and verification challenges, which is why I think that a different kind of interoperability will broad gain market traction before designs with tightly coupled deterministic connections. If you’ve heard Julian Goldman speak on this topic, he provides numerous examples of interoperability that revolve around simple safety interlocks like:
- Using a patient monitor to cease therapy delivery (and sound an alarm, of course) on a PCA pump when respiratory arrest is detected,
- Linking a heart lung machine and ventilator in surgery to ensure that one is turned on when the other is turned off, and
- Linking diagnostic imaging with a ventilator to ensure ventlation is restarted after it is stopped to reduce motion artifact during imaging.
A portion of the 500 patients who die unnecessary deaths every day in U.S. hospitals are killed because simple safety interlocks like these don’t exist. Why? Clearly such interoperability is not rocket science.
FDA MDDS Webinar
As the FDA grinds through the comments submitted in response to their proposed rule for medical device data systems (MDDS), the market awaits the final rule. Regardless of changes between the proposed and final rules, vendors who may be regulated under the new rule will have limited time to prepare.
Awhile back, I was contacted by ComplianceOnline to author a webinar on the FDA’s proposed MDDS rule. After some discussion, we agreed on the following pithy title: The FDA’s proposed Medical Device Data System (MDDS) rule and its implications for currently regulated and unregulated vendors and providers. The key objectives for the webinar are to provide clairification on the proposed rule and explore the consequences for those involved with MDDS – vendors and hospitals.
You can read a description and register for the webinar here. Attendees are encourage to submit questions – which I will answer during and after the webinar.
Alas, the webinar is not free. But compared to what it would cost in my time to lay out the proposed MDDS rule and its implications in detail, the price is a bargin.
If you have any questions about the webinar or MDDS, feel free to contact me (scroll down to the bottom of the page). You can also leave questions on the web page promoting the webinar.
Cisco Changing to Support Health Care
Many things have changed at Cisco since they were visited by the FDA in 2006. Awhile back Kent Gray, global lead for Healthcare Solutions at Cisco, explained to me that the FDA was responding to a brochure produced by Cisco that included a photo of a 7921 handset displaying a patient monitor alarm and associated waveform. The FDA observed that the photo represented labeling of a Class III medical device for which Cisco did not have regulatory approval. Thus began a crash course in the health care school of hard knocks for Cisco.
To Cisco’s credit they have since made many substantive changes to their traditional approach to vertical market marketing in response to the special requirements of health care. During the AAMI conference this week in San Jose, I had a chance to meet with Erik Petersen, the Global Healthcare Solutions & Technology Partnerships Manager, to talk about what Cisco’s been doing in health care.
Health care has strategic importance to Cisco. After their run in with the FDA – a rite of passage for health care vendors – Cisco’s commitment to the market was confirmed by no less than CEO John Chambers.
As a corporation that has experienced enviable growth, the company is grappling with the transition from a $40 billion company to one doing $60 billion. “Cisco wants to offer a strong proactive value proposition in health care,” said Petersen, “rather than just providing a piece of infrastructure that the customer has to deal with for an overall project.” To meet their growth objectives, the company is shifting from a horizontal market company to one focused on vertical markets and applications. To us in health care, this means responding to the unique requirements of our vertical market.
What’s Wrong with the Proposed FDA MDDS Rule
The FDA has proposed to reclassify Medical Device Data Systems (MDDS) from a default class III to class I. (You can read the proposed rule here, and the public comments here.) This is based on the belief that “risks to health from this device would be caused by inadequate software quality. Specifically, the risk to health would be that incorrect medical device data is stored, retrieved, transferred, exchanged, or displayed, resulting in incorrect treatment or diagnosis of the patient.” In my opinion, this is insufficient. Consideration must also be given to the risk of interactions between MDDS and devices.
Until now MDDS has not been a term that was widely used in the medical device or health care information industries. The FDA has proposed a definition that can be summarized as “a device that provides one or more of the following uses: electronic transfer, exchange, storage, retrieval, display or conversion of medical device data without altering the function or parameters of any connected device” (emphasis mine).
First, it is important to point out that even though MDDS’ currently default to class III, the FDA has been operating under their discretionary enforcement policy and has not been enforcing the class III requirements for MDDS. Products that currently meet the MDDS definition have in effect been operating without classification or enforcement; thus the reason for the proposed re-classification. In principle, I agree with the FDA that these types of devices should be regulated, but the question I pose is “why go from class III to class I?” Shouldn’t the classification for MDDS’ be class II?
IEC 80001 – An Introduction
There’s been increasing rumblings in the industry about the soon to be completed standard, IEC 80001. While it is starting to get some discussion, the vast majority of hospitals and vendors have yet to hear about it. This post is an effort to raise awareness and spark some discussion.
The Problem
In December of 2005, the FDA hosted a study session (more here, here and here) to discuss a new and growing threat to patient safety and possible solutions. The threat is the increasing availability of computer controlled medical devices operating in enterprise network environments. Medical devices systems of this kind include patient monitors and central stations, smart infusion pump systems, and devices connected to information systems that do surveillance and alarm notification (Cardiopulmonary, LiveData, Ascom and others).
There are two levels of threat. The first is when medical device systems are used in broader environments, like enterprise networks, which were not anticipated (at all, or at least not fully) by the manufacturer. Once the regulated medical device system is installed in the customer site, how the network environment is designed, managed and changed over time can impact the safety and effectiveness of the medical device.
A different threat emerges when regulated medical devices are combined to create systems of systems that were not anticipated (at all, or at least not fully) by the manufacturer. The actors in this scenario extend beyond the governmental regulatory agency and individual medical device manufacturers, to include third party IT infrastructure vendors, other regulated medical device vendors, and health care providers. When a provider buys a variety of medical device systems and deploys then on an enterprise IT infrastructure, how that infrastructure and medical device systems are configured and interact introduces new and unanticipated risks.
