FDA Targets Risks From Reused Medical Devices - Pamela Scott's Story (Audio Transcript)
Hello. My name is Pamela Scott and I am an employee with FDA’s Center for Devices and Radiological health. Several months ago my mother was scheduled for a colonoscopy at a logical G. I. clinic. The morning of her appointment I dropped her off at the G. I. Clinic but I had concern about that particular clinics ability to make sure that they clean and disinfect the devices that they use for colonoscopies between patients.
So after I dropped my mother off I called the clinic back and I asked to speak with the person responsible for making sure the devices are properly and disinfected between patients. Sometimes we refer to that as reprocessing of the device between patients. I was given the name and number for the head nurse. At this particular clinic the head nurse was responsible for this particular aspect of handling the devices. So I called the head nurse and I asked her about the facilities process and awareness as if relates to cleaning and disinfecting the devices used for colonoscopies those devices are often referred to as colonoscopes.
Well, the head nurse very nicely explained to me that they handle each and every one of their patients as if that patient were there own family member. So that gave me a comfort level that the facility cares about there patients. But it didn’t answer my question. So I proceeded to reference some of the reports in the media about problems with either cleaning or disinfecting different types of colonoscopes and other types of what we call endoscopes between patients.
An endoscope or a colonoscope is a type of endoscope and they’re used to look inside the body. Well, after I referenced some of the media reports then the head nurse then explained to me that they were very aware of some of these media reports. And in fact within there facility they contacted one of the manufactures who devices they use to make sure that they were following the manufactures instructions appropriately they also asked the manufacturer to retrain there staff to again make sure that there staff was following the manufactures instructions.
Well, with that that gave me a heightened comfort level that the facility was not only concerned about their patients but they were aware of the importance of cleaning and disinfecting these devices between patients. They had a heightened of awareness of making sure that within there facility they were following proper procedures. And so this gave me a comfort level that they were adequately providing devices that were safe for use for each patient.