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 firstname.lastname@example.org