Potential difficulties could result from improper placement of instructions, unclear and imprecise language, print size inappropriate for the visually impaired or poorly translated or outdated instructions, the agency says in recently published guidance. Such concerns qualify as adverse events, the agency adds.
The guidance focuses on reusable devices for diagnosis, monitoring, improved function and emergency services. In vitro diagnostic medical devices are not included.
The guidance, which is directed at facilities and providers, stresses that manufacturers are ultimately responsible for how their products are used and will be held accountable for IFUs that don’t consider the user’s knowledge and training.
The guidance offers examples of situations that may occur with poor IFUs and training. In one instance, the MHRA received reports of incorrectly assembled respiratory therapy devices where an expiratory pathway wasn’t provided, ultimately resulting in lung injury.
In another case, after a “cut and push” technique was used to remove an endoscopic gastrostomy tube through the skin, a remnant lodged in the patient’s small bowel, resulting in death. The manufacturer’s instructions recommended only endoscopic removal of the PEG tube. The agency advised that when endoscopic removal wasn’t feasible, appropriate risk assessment and patient follow-up should be done.
Manufacturers should provide all necessary information on storage, pre-use checks, maintenance and cleaning of devices, the MHRA says. Special instructions may also be required to cover systems where devices are used with other devices — such as connecting a blood analyzer to a computer for automatic updating of patient data.