Many eyebrows were raised following 2016’s recall of duodenoscope model TJF-Q180V by Olympus. The voluntary recall was intended to replace the problematic elevator channel sealing mechanisms in the 4,400 Olympus duodenoscopes that were issued prior to 510k clearance for the device. Olympus planned to complete the recall by August 2016 and also planned to conduct […]
Are Duodenoscopes Safe To Use? Read More »
ECRI Institute’s annual list of patient safety concerns has been released. One concern missing from the list that has been a staple for several years is the infection risk associated with inadequate cleaning of flexible endoscopes. With the number of incidences being reported by hospitals and the associated changes to scopes being issued by the
ECRI List of 2017 Patient Safety Concerns Includes Inadequate Safety and Quality Systems Read More »
The editorial team at the Becker’s Infection Control & Clinical Quality website unveiled its top 10 patient safety issues for 2017. Their list was based on study findings and trends over the last year. Sterilization and reprocessing issues represented one of the issues on the list. It’s no surprise to anyone in the industry that
List of Top 10 Patient Safety Issues For 2017 Includes Scope Reprocessing Read More »
Recently, I had a chance to sit down with a couple of Chief Operating Officers (COOs) from hospital clients who use the iRIScope system from Mobile Aspects. The system was developed to help hospitals improve patient safety and documentation around flexible endoscope usage. According to the COOs, this has become a hot topic due to
The Joint Commission Survey From a Hospital COO’s Perspective Read More »
The Federal Drug Administration (FDA) and its 510(k) Clearance program may have played a role in preventing potentially dangerous endoscopes from being adequately tested before being released to the market. Because endoscopes are highly regulated medical devices, the FDA’s approval processes should be able to catch any critical health risks posed by their use. However,
How the FDA May Have Enabled the Recent Epidemic of Endoscope Related Infections Read More »
PENTAX Medical recently issued a field correction to customers on a potential risk for contamination on one of its duodenoscope models. PENTAX duodenoscope model ED-3490TK has been declared a risk for patient infection due to an issue with the silicone adhesive used on the distal tip during manufacturing. In some cases, cracks may form in
Pentax Warns on Infection Risks From Some of its Endoscopes Read More »
A seven-month study recently published by the American Journal of Infection Control found that 60% of gastroscopes and colonoscopes examined tested positive for certain bacterial growth. These bacteria were detected even after being disinfected using the current manufacturer guidelines or additional measures. The scopes examined as part of the study were all manufactured by Olympus
New Research Shows Current Scope Cleaning Processes Not Rigorous Enough Read More »
A potential superbug linked to contaminated gastroscopes at UPMC in Pittsburgh, PA was discussed in a recent article in the Pittsburgh Tribune-Review (01/03/17). The author, Dr. Lawrence Muscarella, wrote that the infected gastroscopes may have infected up to 6 patients with carbapenem-resistant Klebsiella pneumoniae (CRKP), a deadly superbug. This article by Gordon Gibb of LawyersandSettlements.com
Potential Outbreaks Related To Gastroscopes Revealed Read More »
FujiFilm Medical Systems, USA Endoscopy Division (“FMSU-ESD”) declared this week that it is removing some of its older model duodenoscopes from the market. According to FujiFilm, the ED-250XL5, ED-250XT5, ED-450XL5, and ED-450XT5 model duodenoscopes are the models that are being recalled. Per a press release from FujiFilm, which can be found here: “These devices are
Some Fuji Duodenoscopes Pulled From Market Read More »
With all the recent outbreaks related to flexible endoscope usage, proper cleaning of scopes continues to be top of mind for hospitals and patients. The FDA has recently released guidance on mitigating the risk from cross-contamination of scopes, which can be found here. Whether or not this guidance will help reduce the likelihood of a
How Will Recent FDA Guidance On Endoscope Reprocessing Impact Hospitals? Read More »