This exchange occurred during the U.S. Food and Drug Administration Neurological Devices Panel examining the reclassification of electroconvulsive therapy (ECT) devices on January 27, 2011. These are the remarks as published in the public record of the meeting.
MS. CARRAS: I have a question for Dr. Weiner. Dr. Weiner, I did a lot of outside reading to prepare for this appointment, and I was wondering if you could answer Linda Andre’s assertion that you have worked for companies that make electroconvulsive shock machines.
DR. WEINER: Yeah, I’d be glad to answer that. Earlier in my career, I did a small amount of consulting with the device companies. As I said, I was trained in electrical engineering and systems engineering. So I was familiar with more than most psychiatrists are with the electrical properties and gave them advice. It was never more than a miniscule part of any income I had.
DR. BROTT: When was the latest date of that activity?
DR. WEINER: The latest date of that activity, I don’t recall, but I don’t believe any of it was within the past 10 years, but let me add that some of the research that I did in conjunction with a colleague, Dr. Krystal, resulted in a patent by Duke University which is licensed to one of the companies, MECTA, and to avoid conflict of interest, I do not personally receive royalties from that.
DR. BROTT: While you’re up there, do you practice, do you administer ECT?
DR. WEINER: Yes, I do. Yes, I do.
DR. BROTT: And, you know, I noticed you mentioned you have this engineering background. What machine or what device or devices do you use?
DR. WEINER: Well, I’ve used both the presently marketed ECT devices.
DR. BROTT: And you currently use both of them?
DR. WEINER: Yes, I use one more than the other just because that happened to be the one that we had.
DR. BROTT: And how do you, you know, how old are they, and how do you maintain them, and do they ever develop problems? How do you detect problems? What can you tell us about these devices in everyday use?
DR. WEINER: Well, they’re pretty robust. They tend not to break down, and if there’s anything we think wrong with it, then we have it either fixed locally — there are service manuals that come with the machines — or we send it back to the factory to work on, but that’s been very rare that something like that has happened.
DR. BROTT: Could you give us any recent examples with the date? Like the last time it broke down was 1950 or, you know, 19-whatever and what it was.
DR. WEINER: Oh, I think, you know, two, three years ago, one of the knobs that control the chart drive got loose and wasn’t functioning. We had that fixed.
DR. BROTT: Is there any standard maintenance or, you know, in the manual that comes with it or who’s responsible for the machine just to see that it’s doing what it’s supposed to do? I presume this is in a medical center, hospital setting?
DR. WEINER: Right, right. It’s subject to the same medical equipment testing practices that any medical equipment is within a medical center that the medical center tends to have policies and procedures for. They’re not specific to ECT but to all medical devices.
DR. BROTT: What does that mean in terms of this device? Do they come in and look at it or do anything with it?
DR. WEINER: They generally look at it and make sure that there’s no problems with leakage current. There’s not specific tests that they generally carry out. There have been some places that have done those. The service manual includes instructions on how some of those things could be carried out, but there’s not specifics, and that’s true for most medical devices that are used in hospitals.
DR. BROTT: Other questions of the Panel members? Dr. Ellenberg.
DR. ELLENBERG: If you wouldn’t mind staying up. This is Jonas Ellenberg. Is there a fail-safe mechanism on the ECT machines that would not allow a certain current level with a certain level without an override by a senior official at the hospital or are they —
DR. WEINER: Yeah, there are constraints on the maximum output charge that actually come actually through the FDA. The FDA has maintained a limit which goes back a number of years so that there’s been no increase allowed in quite a number of years.
DR. ELLENBERG: That’s not my question. Does the machine regulate that? Does it stop?
DR. WEINER: Oh, you cannot —
DR. ELLENBERG: You cannot do it.
DR. WEINER: — set it to go higher than that. Plus, there’s voltage limiting built into the machine. So if the impedance was apparent, the machine would shut off.