Preventing and Handling Medical Device Failures

Preventing Failures 

Using medical devices correctly is the first step in preventing failures. To do this, follow the medical device manufacturer’s instructions for use (IFU) and your organizational policy and procedures, both of which should be readily available and easily accessible.1 Following both the manufacturer's IFU and organizational policies and procedures facilitates the use of the product in the manner it was intended, increasing the chances of medical device effectiveness. Medical devices used outside these established parameters decrease the potential effectiveness of the device and can increase the risk of patient and personnel injuries. 

Handling Failures

In the event of a medical device failure, follow your health care organization's policy and procedure and guidance from the manufacturer’s IFU. The process can differ depending on the medical device involved, such as equipment, single-use (disposable) products, or reusable devices.  

For malfunctioning equipment, if allowed by the manufacturer’s IFU, health care organization policy and procedure, and the surgeon or anesthesia provider using the equipment, sometimes you can power the device off and then back on again after five to 10 seconds. Doing so may “reset” the medical device, like a computer or smartphone. This process may be especially beneficial if the device has a frozen screen or error message. Make note of the error message before you reset the device; you may need it to report the failure.  

For equipment, handling failure can include  

• safely removing it from service,¹
• removing it from the OR,
• having it cleaned by environmental service personnel when needed,¹
• “tagging” it with information identifying it as out-of-service, 
• filling out any required forms related to equipment malfunctions,
• sequestering it in a location dedicated to broken equipment, and
• notifying the appropriate personnel. 

The type of personnel notified may depend on the severity of the incident and how specialized the piece of equipment is. Consider the differences between these two scenarios:  

• If an electrosurgical unit (i.e., bovie) malfunctions by shutting down and no patient injury occurs, and there are many other units available, then only notifying biomedical engineering personnel may be appropriate. 
• If a highly specialized piece of robotic equipment fails or seriously injures a patient, and there is only one such device, and you need it for the next procedure, you might notify biomedical engineering personnel, the manufacturer’s representative, the charge nurse, and the nurse manager. 

For single-use (ie, disposable) devices, handling failure can include  

• safely removing the item from the sterile field using standard precautions,¹
• containing it in a manner to prevent personnel bloodborne exposures,¹
• attaching a biohazard label to clarify that it has been used and has bloodborne contamination,¹
• attaching a form or note identifying the item and providing your contact information,
• retrieving the original packaging (when possible),¹ 
• giving the device to the individual responsible for follow-up processes (e.g., charge nurse, nurse manager, biomedical engineering staff). 

For reusable medical devices, such as surgical instruments, blood pressure cuffs, or pneumatic tourniquets, handling failure can include 

• safely removing the item from service using standard precautions when appropriate,¹
• cleaning and disinfecting the device per the manufacturer’s IFU when needed,¹
• marking the device as malfunctioning, such as 
  • “tagging” the item with an instrument repair tag or
  • attaching a tag, form, or note about the device malfunction and with your contact information,
• sequestering the item for safe transport to the appropriate department personnel for follow-up,¹ and
• communicating the problem to the follow-up personnel.  

Replacing Failed Devices 

When a medical device fails, the nurse often first considers the safety of the patient and personnel, quickly followed by performing an assessment about whether the medical device needs to be replaced immediately. Therefore, knowing where devices are stored or where to find that information quickly is essential. If you don’t know where to find a replacement device, depending on the situation's urgency, you can consult a resource guide or call the float nurse, charge nurse, nurse manager, or other experienced nurse to help you. If you need to replace the device quickly and you cannot locate another, it is crucial to convey this information to personnel in your chain of command so they can also help you work through troubleshooting additional devices that might work in the situation or contacting a manufacturer representative.   

Reference