Some time ago Tim Gee pointed out that a major vendor for an in hospital communication system included the following statement in its documentation:
“This product is not intended for use with patient monitoring devices or other patient care devices. Do not use this product as the primary communications tool in health care environments, as it may use an unregulated frequency band that is susceptible to interference from other devices or equipment.”
Of course “primary communication” was exactly why the product was being purchased, and arguably what it was being sold for.
When discussing Clinical Decision Support (CDS) (here) I have pointed that it is common for CDS creators to in essence say that one should not rely on the output of the product, but instead always second guess the advice provided. This perhaps approaches a warning that I proposed for a product that I thought was seriously defective: DO NOT USE THIS PRODUCT. Maybe I was being facetious.
These examples may pale in comparison to the following disclaimer for medical image processing software:
<The manufacturer> ” SHALL HAVE NO LIABILITY OF ANY KIND FOR ANY DIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT, FAILURE OR MALFUNCTION OF THE SOFTWARE, OR USE OF ANY <manufacturer> DOCUMENTATION, WHETHER THE CLAIM IS BASED UPON WARRANTY, CONTRACT, TORT OR OTHERWISE. <Manufacturer> MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WHETHER ARISING FROM STATUTE, COMMON LAW, CUSTOM OR OTHERWISE.”
The all caps format is verbatim. Ironically I discovered this disclaimer while reading a UK Medical Device Alert. The reason for the alert was that some versions of the software under some circumstances could change the orientation of the image being presented. This of course could be a bad thing. However our stalwart manufacturer noted that “No upgrade is being provided due to the “remote” probability and the available workaround for the issue. This issue is being corrected as a part of our service updates for the future software releases.” The referenced workaround is in effect, to always make sure that the image is being presented correctly. As a fan of the term “upgrade” I also note that if they were going to provide an upgrade, which they aren’t, this would be a use of the term to mean fix-something-that-is-broken, as opposed to it-is-good-but-we-are-making-it-better.
Since I am also a fan of the proliferation of version numbers it was of interest to me to note that the effected products were version “6.0, 6.1, 6.2, 6.3 (except 6.3.1), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5”. One of course wonders why 6.4.4 and 6.4.5 escaped the bug, but not 6.5.
Apparently the Medicines and Healthcare Products Regulatory Agency (MHRA), which is more-or-less the UK’s FDA, was not intimidated by the manufacturer’s notice in their URGENT: MEDICAL DEVICE RECALL (FIELD SAFETY NOTICE) that the labeling addendum included the demand that, “No part of this work may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic or mechanical, including photocopying and recording, or by any information storage or retrieval system without permission in writing from” <the manufacturer>, or maybe they had permission. However the recipient would not automatically have permission it seems, and thus they would be precluded for actually following the instruction to “Notify your users of the issue described in this letter.” Well, I guess you could tell the users about it, but perhaps not actually make the addendum available directly to them. You could point them to the MHRA notice I suppose.
On a related note this reminded me of a discussion by the consumer advocate, “The Haggler,” in the New York Times. The issue was a failure of a backpack with “a lifetime guarantee”. The manufacturer explained that this meant the lifetime of the backpack (I am not making this up), and that since the backpack had obviously reached the end of its life, the warranty did not apply. The Haggler has also discussed various draconian Terms and Conditions of sale from certain internet vendors.
It might be fair to say that disclaimers are largely unseen, unread and/or ignored by users. In this regard how many Terms of Agreement on a web site have you actually read? None-the-less, at one time or another a situation will occur when you have a complaint (e.g. the product doesn’t work right and as a result a wrong diagnosis occurred which resulted in injury to the patient), and the response may well be “see disclaimer.” Please see your attorney to determine how effective such a disclaimer is. But in any case, it might have been a good idea to be aware of the disclaimer before you bought the product.
[author] [author_image timthumb=’on’]http://medicalconnectivity.com/wp-content/themes/deadwood/images/authors/Hyman.jpg[/author_image] [author_info]William Hyman is Professor Emeritus of the Department of Biomedical Engineering at Texas A&M University. He recently retired and has moved to New York City where he continues his professional activities.