The purpose of this FDA safety communication, issued September 17, 2015, is to share preliminary information regarding infections associated with the use of reprocessed flexible bronchoscopes. Although this information is limited, health care providers may benefit from awareness of the issues the FDA is seeing and of steps they can take to mitigate possible risks to patients.
A flexible bronchoscope is a thin, lighted tube that is threaded through the nose or the mouth to allow a physician to examine a patient’s throat, larynx, trachea, and lower airways. Bronchoscopy may be done to diagnose problems with the airway, the lungs, or with the lymph nodes in the chest, or to treat problems such as an object or growth in the airway. Approximately 500,000 bronchoscopy procedures are performed in the United States each year.
Bronchoscopes must undergo reprocessing in between patient uses to clean the devices of soil and contaminants and to inactivate microorganisms by disinfection or sterilization. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. If the process is not followed meticulously, the flexible bronchoscope can remain contaminated, potentially resulting in infection transmission from one patient to the next.
The FDA has undertaken an ongoing, comprehensive investigation into infections associated with reprocessed reusable medical devices, working with federal partners, manufacturers, and other stakeholders to better understand the critical factors contributing to device-associated patient infection and how to best mitigate them. In the March 2015 Reprocessing Final Guidance, the FDA identified bronchoscopes as being part of a subset of devices that pose a greater likelihood of microbial transmission and represent a high risk of infection if they are not adequately reprocessed, and are proactively investigating these devices to determine if additional steps should be taken. As part of that investigation, the agency has observed commonalities in some of the reports to the FDA regarding infections associated with flexible bronchoscopes. Based on current knowledge, the risk of infection transmission presented by reprocessed bronchoscopes appears to be lower than the risk of infection transmission presented by reprocessed duodenoscopes.
Between January 2010 and June 2015, the FDA received 109 Medical Device Reports (MDRs) concerning infections or device contamination associated with flexible bronchoscopes. When compared to the number of bronchoscopy procedures performed in the U.S. each year, this is considered a small number of MDRs. However, in 2014, the FDA received 50 MDRs that mentioned infections or device contamination associated with reprocessed flexible bronchoscopes, which prompted additional investigation on this issue.
A small number of these reports indicate persistent device contamination despite following the manufacturer’s reprocessing instructions. The FDA continues to evaluate these reports through follow up with health care facilities and manufacturers to determine whether device contamination persisted despite meticulous adherence to the manufacturer’s reprocessing instructions and whether other factors may have contributed to these events.
While not every medical device report contains information sufficient to definitively identify the factors contributing to persistent device contamination or device-associated infection, the analysis to date has identified two recurrent themes:
- Failure to meticulously follow manufacturer instructions for reprocessing, including:
- Lack of pre-cleaning at point of use. Pre-cleaning typically includes surface wiping and channel flushing to prevent drying of blood, tissue, and other biological debris;
- Failure to perform thorough manual cleaning before high-level disinfection (HLD) or sterilization;
- Failure to flush or brush channels;
- Use of expired detergent or high-level disinfectant;
- Insufficient flushing, rinsing, and/or drying after HLD.
- Continued use of devices despite integrity, maintenance, and mechanical issues, including:
- Persistent device channel kinks or bends;
- Channel wall scratches, divots, or crevices;
- Holes, cracks, or other imperfections in the distal end;
- Use of repaired or refurbished devices using out-of-specification parts;
- Use of devices despite residual material in the instrument or suction channels.
The FDA recommends that facilities that reprocess flexible bronchoscopes take the following precautions:
- Strictly adhere to the manufacturer’s reprocessing instructions. It is critical that staff responsible for reprocessing bronchoscopes have the manufacturer’s instructions readily available to promote strict adherence to the reprocessing instructions in the device labeling.
- Do not skip steps. Be sure to follow all pre-cleaning, manual cleaning and HLD or sterilization steps.
- Ensure that staff who reprocess soiled bronchoscopes understand the importance of manually cleaning the scope thoroughly before it is disinfected or sterilized. Meticulous cleaning is an essential part of endoscope reprocessing. Failure to perform adequate cleaning may result in failure of HLD or sterilization.
- Use only bronchoscope manufacturer-specified cleaning accessories, high-level disinfectants, enzymatic cleaning agents and detergents and follow their directions for use.
- Immediately remove from service for assessment and repair or replace any bronchoscope that fails a leak test (performed to assess scope integrity after every procedure), or shows visible signs of damage. Examples of damage may include: loose parts, damaged channel walls, kinks or bends in tubing, holes in the distal end, or other signs of wear or damage.
- Follow the manufacturer’s recommendations for preventive maintenance and repair of the device. For additional information on maintenance and repair services, refer to the manufacturer’s information provided with the bronchoscope, or directly contact the manufacturer.
- Implement a comprehensive reprocessing quality control program. The reprocessing program should include written procedures for monitoring, training and adherence to the program, and documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure.
- After reprocessing, store bronchoscopes in a manner that will minimize the likelihood of contamination or collection and retention of moisture, according to manufacturer’s instructions.
- Refer to the American College of Chest Physicians and American Association for Bronchology Consensus Statement: Prevention of Flexible Bronchoscopy-Associated Infection: 2005 for recommendations regarding bronchoscope reprocessing.
- Instruct patients about what to expect following the procedure and when to seek medical attention. The physician should be called if, following the procedure, the patient has symptoms such as fever, pain, nausea, and vomiting, that may be a sign of a more serious problem.
Advances in medical technology have generated more complex reusable medical device designs that are more difficult to clean and sterilize. In addition, there has been a significant advance in knowledge and technology involved in reprocessing reusable medical devices. The FDA’s March 2015 Reprocessing Final Guidance reflects the scientific advances in these areas, and it identifies a subset of reusable devices that pose a greater likelihood of microbial transmission and represent a high risk of infection (subclinical or clinical) if they are not adequately reprocessed.
Ensuring the safety of reprocessed medical devices is a shared responsibility among the FDA and other federal agencies, state and local health departments, medical device manufacturers, health care facilities, professional societies and others. The FDA is actively engaged with many of these stakeholder groups to better understand the causes and risk factors for transmission of infectious agents associated with these devices and to develop solutions to minimize patient exposure.
See the FDA Drug Safety Announcement
See also Medical Law Perspectives, October 2015 Report: Liability for Use of Unsterile Medical Instruments (to be published October 6, 2015).
See also Medical Law Perspectives, January 2012 Report: Hospital-Acquired Infections: Who Is Liable and Why?
See the Medical Law Perspectives March 11, 2015, Blog: Uncleanable ERCP Duodenoscopes: Manufacturer, Hospital, and Physician Liability?