William Hyman: New Warnings and Old Users

From time to time, I have evaluated situations in which a manufacturer has revised instructions for use and/or on-device warning labels for a product, and thereby provided this new information for new purchasers. In some cases, this revised information directly addressed safety issues; the new instructions or warnings were intended to mitigate a known hazard. In these cases, the manufacturer had concluded (rightly or wrongly) that the hazard was not the result of a design issue, but stemmed from user confusion. The thinking appears to have been that further instructions or warning language about the device would be adequate to mitigate the risk.

A fairly obvious and important question is whether the new instructions or warnings need to go to existing owners or users of the product? Or to put it another way, if a new user needs the new information for enhanced safety, how can it be that the “old” user doesn’t also need that information? I will avoid the issue here of whether distribution to existing owners is “required” and address just the safety issue. In this regard, I would note that if asked whether new instructions are distributed to existing users, a manufacturer responds “no” because such action is not required, then that manufacturer has a perspective that’s opposite of what I see as a mindset of “safety first.”

This issue can be addressed for three broad types of devices: single use, implants, and permanent hospital equipment. In the case of single-use devices, it can be assumed, at least after some period of time, that the old instructions and warnings are no longer available. If this is the case, then a new purchase would include the new information. If the device itself is new to the user, we might assume that that the user will read the instructions and warnings, and thereby be properly informed. If the user is familiar with the product (which is unchanged in this scenario), then it can be assumed that the user will read the new material only if it is brought to his attention. This might be done with prominent “flagging” or a notice about the new information. Without such a flag, experienced users could not be expected to read the instructions and warnings each time they open one of the devices, since they would likely assume that their prior knowledge remained valid.

The situation for implants would be similar where the information might pertain to patient selection, implantation technique, risks, or follow-up. Unless it was brought to a surgeon’s attention that there was new information, a surgeon experienced with the product would be unlikely to re-read the package insert. Again, appropriate flagging might be helpful here. The assumption is that new users would read the information.

For permanent hospital equipment, the issue is bit more complicated because existing users would have the instructions and warnings that came with the original purchase. If they did not purchase a new device, they would not have the new information—nor would they have any way to know that new information was being provided with newly purchased units. They would be trapped in the old knowledge, lacking the new information that the manufacturer had thought was necessary and appropriate to provide to new purchasers. Even if a new unit were purchased, those having older units of the same device would not necessarily know that there was new information—unless there was specific notice in that regard. For on-device labels, this could lead to a situation where older units had one set of warnings and newer units had a different set of warnings. If the devices were examined side by side, the difference in the labels might be noted, and the manufacturer might then be asked to upgrade the old labels. Short of that, it’s not inconceivable to think that you could have one “freshly warned” group in a hospital using a device, but another group using the device completely unaware of the new warning. That cannot be good.

True concern for patient safety and understanding the logic of warnings suggests to me that new instructions and warnings need to be brought to the prominent attention of existing owners and users, not just new purchasers. This would be the proper way to keep everyone informed. And such an approach would avoid the need to rationalize the following question: How it can be that if I buy a new device, I need (and get) new and presumably important safety information, but if I have an old one I don’t need that same information?

William Hyman, ScD, is professor emeritus of biomedical engineering at Texas A&M University. He now lives in New York where he is adjunct professor of biomedical engineering at The Cooper Union. Hyman may be contacted at w-hyman@tamu.edu

4 thoughts on “William Hyman: New Warnings and Old Users

  1. Even if the new IFU or other labeling were cleared by the FDA, this has not meant that past users were made aware of it. And it is not the FDA’s responsibility to put new IFUs in the hands of customers; it is the manufacturer’s. Equally, a recall, if one were indicated, is also the manufacturer’s responsibility, and almost all recalls are “voluntary” actions by manufacturers–not actions taken by the FDA. Even when the FDA subsequently classifies a recall and posts it, it is almost always acting on a recall that has already been undertaken. Furthermore, recalls are pushes since they require the manufacturer to contact their customers.

    We are also now in the domain of “required to,” which is a different subject than what the customer needs to safely use the device.

    If “push” is a nightmare, so is every user facility having to routinely check for updates for every medical device that is used.

  2. William,

    I would suggest it’s the responsibility of the user and hospital to ensure they have access to the most current information. I have seen a number of FDA, MHRA, and TGA safety alerts informing users that changes have been made to the IFUs. Like any other safety alert, the users need to act on it (i.e., remove the unit from service, make sure the company has access to it to address the issue, or make sure they get a updated copy of the IFU)–unless of course the regulatory bodies have not been informed of the IFU update, which is another issue .

    However, in the spirit of “patient safety,” IFUs and their use and access are still stuck in the dark ages: 99% of all clinical reference documentation has been accessible via the hospital intranet, and yet equipment IFUs are still generally available as soft covered cheap booklets or CDs.

    I run the Clinical Equipment User Manual Library for over 200 hospitals in the UK and Australia and getting safety and quality, clinical educators and nurse managers to buy into the concept of using the IFU as a point-of-care clinical reference tool is still an uphill battle.

    Many of the established manufacturers have produced brilliant reference documents, quick guides, user troubleshooting guides, set-up guides etc. However, the mindset that the user manual is to complicated, not user friendly, etc., still persists.

    • When there is an alert, it is certainly appropriate for users that see it to act on it. More challenging is when there is no alert and then, following your logic, the user has to regularly and systematically contact all manufacturers to ask if there is anything new. This is not practical, and I’m not even sure it would be effective. Who do you ask exactly? Not everyone has access to a user manual librarian who could perform this task. And it is not clear that even you routinely provide such information or just “shelve” it in case someone comes looking for it.

      Pushing new information to users is far more efficient than each user having to pull that information, especially when they don’t know that new information is available.

      • The IFU is part of the device. If a company make changes to it and doesn’t notify the regulator, then the regulator has to take the appropriate action with respect to that manufacturer. Why is it any different than any other alert? Hence, the user should not have to contact the manufacturer on a regular bases at all (and if you are aware of a change in the IFU which has not been brought to the attention of the FDA then you should report it). There is no need to reinvent the wheel.

        Pushing information onto users, in my experience, would be a nightmare. Locating equipment, let alone the number of people who use it, would be just as challenging as mapping the solar system. Within an clinical team (or any team at all for that matter, including a biomed department) there is a natural propensity for individuals to migrate to areas of interest, many outside their formal positions. This is particularly evident with respect to technology. Making sure the IFUs are available on the intranet (the hospital’s responsibility), alongside all the other reference material, is a practical way to ensure those tech-savvy individuals don’t have to jump through hoops to look for the manufacturer-supplied information. As the biomed department has organization-wide responsibility for all medical devices, it should be the key driver of this type of service. The department also has a responsibility to manage alerts, and therefore any changes in the IFU can be directed to the appropriate people within a department when necessary.

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