The FDA has recently focused on the following medical devices and technologies, because each has been recently linked to bacterial outbreaks and discussed in the news:
Heater-Cooler Devices | Duodenoscopes | Automated endoscope reprocessors (or, AERs) || Bronchoscopes || Laryngoscopes || Flexible Laryngoscopes || Rigid Laryngoscopes ||
1. The “Heater-Cooler Devices” page
This page includes important about the risk of contaminated heater-cooler devices infecting patients and lists the FDA communications discussing heater-cooler devices, including:
- Heater-Cooler Devices: Information for Patients
- FDA’s Ongoing Investigation of Nontuberculous Mycobacteria Infections Associated with Heater-Cooler Devices
- Heater-Cooler Devices: Information for Health Care Providers and Staff at Health Care Facilities
Click here to view the entire, comprehensive contents of this “Heater-Cooler Devices” page.
2. The “Duodenoscopes” (and Echo-endoscope) page
This page includes important about the risk of contaminated duodenoscopes infecting patients and lists the FDA communications discussing duodenoscopes, including:
- Sen. Patty Murray (D-WA): “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients” (January 2016)
- Warning Letter – Fujifilm Medical Systems U.S.A., Inc. 8/12/15
- Warning Letter – Hoya (Pentax) Corporation 8/12/15
- Warning Letter – Olympus Corporation of the Americas 8/12/15
Click here to view the entire, comprehensive contents of this “Duodenoscopes” page.
3. The “Automated Endoscope Reprocessors (AERs)” page
This page includes important about the association of AERs with superbug outbreaks and lists the FDA communications discussing these devices, including:
- Sen. Patty Murray (D-WA): “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients” (January 2016)
- ASGE Technology Committee: Parsi MA, et al. Automated endoscope reprocessors. Gastrointest Endosc. 2016 Dec;84(6):885-892.
- Muscarella LF. Automatic flexible endoscope reprocessors. Gastrointest Endosc Clin N Am 2000 Apr;10(2):245-57.
- Shellnutt C. Advances in Endoscope Reprocessing Technology and Its Impact on Pathogen Transmission. Gastroenterol Nurs 2016 Nov/Dec;39(6):457-465.
- Botana-Rial M, et al. A Pseudo-Outbreak of Pseudomonas putida and Stenotrophomonas maltophilia in a Bronchoscopy Unit. Respiration 2016;92(4):274-278. Epub 2016 Sep 15.
- Graziano KU, et al. Methodological proposal for validation of the disinfecting efficacy of an automated flexible endoscope reprocessor. Rev Lat Am Enfermagem 2016 Aug 8;24:e2745.
Click here to view the entire, comprehensive contents of this “AERs” page.
This page includes important about the risk of contaminated bronchoscopes transmitting CRE and related superbugs, and lists the FDA communications discussing these devices and several regulatory reports, including:
- To be completed soon.
5. The “Flexible Laryngoscopes” page
This page includes important about the risk of contaminated flexible laryngoscopes infecting patients, including:
- To be completed.
6. The “Rigid Laryngoscopes” page
This page includes important about the risk of contaminated rigid laryngoscopes infecting patients, including:
- To be completed.