FDA recommend using single-use bronchoscopes

The U.S. Food and Drug Administration (FDA) is providing updated recommendations for medical device providers regarding bronchoscopy.

1、Recommendations for Patients and Caregivers：

The FDA continues to believe that for most patients, the benefits of undergoing bronchoscopy outweigh the risk of infection.

2、Recommendations for Health Care Facilities and Staff：

Consider using sterilization instead of high-level disinfection when feasible, because sterilization has a greater safety margin than high-level disinfection. Steps should include precleaning, leak testing, cleaning, and sterilization.

（1）If sterilization is not available, then high-level disinfection steps should include precleaning, leak testing, cleaning, high-level disinfecting, rinsing with tap or utility water followed by alcohol flushing or with critical (filtered or sterile) water, and drying.

（2）Use only manufacturer-specified cleaning accessories, high-level disinfectants, enzymatic cleaning agents, and detergents.

You should not use damaged devices or those that have failed a leak test, as they could be a potential source of contamination. Examples of damage may include:

（1）Loose parts

（2）Damaged channel walls

（3）Kinks or bends in tubing

（4）Holes, cracks, or imperfections in the distal end

（5）Other signs of wear or damage

You should not reprocess or reuse single-use bronchoscopes.

3、Device Description and Background：

A bronchoscope is a type of endoscope, and consists of a thin flexible lighted tube that is threaded through the nose、mouth or other access point to the lower airways (for example：through a tracheostomy tube), to enable a doctor to examine a patient's throat, larynx, trachea, and lower airways. A bronchoscope may be used to diagnose abnormalities in the airway, the lungs, or lymph nodes in the chest, or to treat issues such as an object or growth in the airway.

There are two types of bronchoscopes：

（1）Single-use (disposable) bronchoscopes are only intended to be used for one patient and do not require reprocessing.

（2）Reusable bronchoscopes can be used on multiple patients. These devices must undergo reprocessing in between uses, to clean the devices of soil and contaminants, and to inactivate microorganisms by sterilization or disinfection.

FDA Actions：

The FDA is committed to the continued evaluation of the safety、effectiveness and availability of medical devices.The FDA takes the risk of infection with reusable endoscopes very seriously, now recommend using single-use bronchoscopes.