Packed up our booth and took flight again, this time to an area slightly sunnier. UniteOR was in attendance at this years IAHCSMM Conference in beautiful Fort Lauderdale, Florida. The buzz around the conference this year seemed to range from new technology and IFU’s to AAMI updates and sterilization standards. Although all topics exude great importance, one of the most repeated topics was scopes. After several superbug outbreaks across the Unites States, some resulting in deaths, caused by improperly sanitized duodenoscopes, scopes and IFU’s have been in the spotlight for those involved in the sterile processing industry. The FDA has released “guidelines” that should now be followed in order to avoid future outbreaks.
The endoscope controversy originated back in February at the Ronald Regan UCLA Medical Center which resulted in the possible infection of 179 people and two deaths. Then, early in February, Cedar Sinai in Los Angeles had 4 patients that were infected with the same superbug. Other facilities across the United States, including one in Seattle, have also confirmed cases of the infection, all due to the use of improperly sanitized duodenoscopes. This particular endoscope was marketed for years without any clearance.
Three months ago the FDA issued a “general warning” to all hospitals against the duodenoscope. According to The Daily Briefing, in this warning they announced that duodenoscopes are difficult to clean, and “may facilitate the spread of deadly bacteria.” The FDA also acknowledged that even if the manufacturer’s IFU’s were followed when cleaning the scope, that alone still may not remove all of the deadly bacteria.
The FDA stands by the belief that endoscopes are an important device that helps treat patients, and should not be recalled. On May 14th and 15th the FDA will host a two-day meeting to further discuss the infections caused by duodenoscopes and delve into finding a better solution for the reprocessing of these instruments.
Many of the discussions at IAHCSMM wrapped up with the same question, how can we provide safety to patients yet still provide them with the most current and effective procedures and processes?
“FDA Releases New Rules for Testing Device Linked to Superbug Outbreak.” FDA Releases New Rules for Testing Device Linked to Superbug Outbreak. The Daily Briefing, n.d. Web. 08 May 2015. <http://www.advisory.com/daily-briefing/2015/03/13/fda-releases-new-rules-for-testing-device>.
HealthDay, WebMD News from. “2nd Hospital Reports Superbug Linked to Endoscopes.” WebMD. WebMD, 5 Mar. 2015. Web. 08 May 2015. <http://www.webmd.com/news/20150305/superbug-infection-endoscopes>.
“Medical Scope Now Tied to Wisconsin Superbug Outbreak | Al Jazeera America.” Medical Scope Tied to Wisconsin Superbug Outbreak. America Tonight, n.d. Web. 08 May 2015. <http://america.aljazeera.com/watch/shows/america-tonight/articles/2015/3/4/Medical-scope-tied-to-Wisconsin-superbug-outbreak.html>.
Terhune, Chad. “UCLA Superbug: Lawmaker Asks Congress to Investigate FDA Response.” Los Angeles Times. Los Angeles Times, 23 Feb. 2015. Web. 08 May 2015. <http://www.latimes.com/business/la-fi-ucla-outbreak-congress-20150223-story.html>.