Many of us use medical devices in our everyday life without necessarily being ill, or even being aware of using them. Glasses, condoms, digital thermometers and pregnancy tests are considered medical devices. The user guide and labels on these devices are important parts of safety for medical devices. This is also the most accessible information that you can get a hold of to understand how to safely use a medical device.
Even though medical device instructions for use are easy to understand for the target user group, it can be hard to tell what the instructions actually mean. This is a layperson’s guide to understanding medical device instructions for use to keep you safe.
Instructions for use can vary from leaflets to printing on the packaging
Medical devices are regulated by the Medical Device Regulation in the EU. This means that the labels and instructions for use are under the scrutiny of regulatory bodies. In the European Union, medical devices must carry a CE mark to show that they meet relevant requirements for the market.
Instructions of use can vary from leaflets inside the packaging to short descriptions of use on the packaging or material of the medical device. As an example, on the packaging of surgical tape, you may sometimes only find brief information relating to the use of the medical device printed on the packaging.
Medical devices that are safe to use do not require instructions for use
Medical devices should always be classified according to their potential risk level. Manufacturers are not required to include instructions for use for the lowest classes of medical devices if they can be used safely without instructions. This applies to class I and class IIa medical devices.
The intended use or purpose tells the user how the device is meant to be used
The intended use is a very important statement, both for the user and the manufacturer. The intended use essentially explains who and for what purpose the medical device is intended to be used for.
If you use a medical device for another purpose or in a different way, it may not be safe or have the desired effect. A good example is insulin pens which are intended to be used multiple times for just one individual person. Yet, some people share them, which can lead to infections or worse.
Contraindications are the conditions that a medical device manufacturer absolutely do not want you to use a medical device for. This can be because there is no evidence that the device would perform safely and effectively for a particular patient group or particular indication or disease, or it might even be that the device is not safe to use.
The irony is that the device may very well be safe and effective for contraindicated indications or patient groups, but there is not data to support that. That is one reason for why a manufacturer has to contra-indicate specific patient groups or conditions. The other reason is that the device is actually not safe nor effective to use for the contraindicated indications or patients.
Relative and absolute contraindications
There are two kinds of contraindications, relative and absolute. Relative contraindications mean that you should be careful when combining two medical devices, procedures or drugs. The exception is if the benefits of doing so are considered to compensate for the potential risks. An example would be having an x-ray during pregnancy, which is not recommended unless absolutely necessary.
Absolute contraindications mean that a medical device could cause a situation that is life threatening. An example of this would be a person who is allergic to a certain substance in a medication. To consume a medication that contains this could be fatal. In medical device instructions for use, it is not common to specify what type of contraindication the instructions refer to. But, either way, you should not use a medical device against the contra-indications.
Inform the user of any residual risks
Residual risks is another way of expressing side-effects. Often, these are the risks that remain after the manufacturer has done everything they can to reduce the risks involved in the use of a medical device. Many times, this means that there is nothing else that can be done to further reduce risks.
When you use a medical device or other products, you should remember that there are always certain risks involved. By using the device, you are exposing yourself to these risks, so read the disclosure of residual risk to make a well-informed decision on if you are prepared to expose yourself to the risk compared to the potential benefits of the medical device.
Use warnings to avoid hazardous situations
Warnings may sound similar to residual risks, but they actually have a different purpose. Warnings are put in place to provide you with information to keep you safe. The manufacturer is putting trust in you to take certain actions or precautions or to avoid doing certain things to prevent hazardous situations.
As you may have learned, the instructions for use have a much more important purpose than telling you how to use a medical device. The instructions for use are there to help you use a medical device correctly for it to be effective, and to keep you safe.
There are many everyday items that are considered medical devices, such as condoms, glasses and even sports tape. By reading the instructions for use properly, you will have a better understanding of the risks involved as well as the recommended usage for these products.