CS QUESTIONS • CS ANSWERS
When to reprocess stored scopes; CS department practice assessment
by Ray Taurasi Q
My organization is currently debating the defi nition of “reprocess” in the context of
recommendations regarding how long fl ex- ible endoscopes can be stored without being reprocessed before use. Regardless of how many days our multidisciplinary team decides to set as the limit, the question of which steps, exactly, should be performed to reprocess the scope after reaching the limit is one where I have not been able to fi nd a clear recommen- dation. My understanding is that the scope should be fully reprocessed, including all of the normal steps. Others argue that this approach is overkill, and not only causes needless wear to such infrequently used endoscopes, but also wastes resources. These folks claim that a cycle through the automated endoscope reprocessor (AER) is all that is required to get the scope ready again for patient use. We need expert advice.
the fi rst place. The answer of course is that the scope may have become contaminated while in storage. The nature and degree of that potential contamination is uncertain. The area or parts of the scope that are contaminated are unknown. Is the contamination organic, bacterial, or some other soil source? The general rule and practice in sterile pro- cessing is that when a surgical instrument or medical device, such as an endoscope, becomes contaminated or is potentially contaminated the entire device including all it’s parts are to be reprocessed. This means that all steps in the cleaning, decontamination and disinfec- tion process are to be followed in accordance with the device manufacturer’s IFUs. Many AERs do not have a cleaning phase, they only provide a disinfection cycle, thus the scopes must be thoroughly cleaned via a manual cleaning process prior to being placed in the AER for disinfection. In order for the disinfec- tion process to be effective a device must fi rst be cleaned. Residual soils can act as a barrier to the required intimate contact between all surfaces and parts of the medical device and disinfectant. There can be no short cuts to reprocessing protocols.
A
I am the director of nursing for periop- erative services. I was at a recent confer- ence which discussed the alert issued by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administra-
Q
To answer your question let’s consider why the scope is being reprocessed in
SUBMIT YOUR QUESTIONS email:
editor@hpnonline.com phone: (941) 927-9345 ext.202
tion home page (FDA) relative to epidemic failures in reprocessing, sterilization and disinfection procedures in hospital CS depart- ments. The alert requires that hospitals should immediately have a professional assess the performance of their central sterile processing department to ensure they are doing things correctly. Would it be acceptable for me to assign one of my OR nurses to conduct this assessment or do I have to hire a professional consultant to do this?
Need For Healthcare Facilities to Review Procedures for Cleaning, Disinfecting and Sterilizing Reusable Medical Devices.” This was in response to the high number of well documented breaches and failures in compli- ance to reprocessing protocols which have led to several adverse patient care outcomes including deaths. This alert was not directed toward any one hospital department. The alert included all healthcare facilities, hospitals, am- bulatory surgical centers, clinics and offi ces. The alert did state that healthcare facilities should arrange for a healthcare professional with expertise in device reprocessing to imme- diately assess their reprocessing procedures. The assessment should ensure that repro-
A
cessing procedures are done correctly to allow the required time for reprocessing personnel to follow all steps in the device and equipment manufacturer’s IFUs precisely. The alert also stated: • Staff should be retrained with competencies documented.
• Manufacturer’s instructions for use should be obtained and followed.
• Suffi cient time should be allowed to com - ply with all IFUs (this would include pro- cessing equipment, medical device, chem- istries, cleaning devices, testing tools, etc.).
• Ensure that availability of the appropriate number and types of processing equipment is available (e.g., sonic washers, accessories, fl ushing devices, manual wash stations and sinks).
• Perform regular audits of the cleaning , dis- infection, sterilization and storage processes.
30 May 2016 • HEALTHCARE PURCHASING NEWS •
hpnonline.com
In September 2015, the FDA and the CDC did release an alert titled “Immediate
It should be noted that this alert is not solely directed to the Sterile Processing Department — it includes any area in a facility or organiza- tion that performs any cleaning, disinfection or sterilization of medical devices. I have found that most hospitals have some degree or portion of reprocessing being conducted outside of the sterile processing area (e.g., OR, Clinic, Physician offi ce, L&D, Endoscopy, GI Lab, etc.). Thus any and all areas that perform any aspect of reprocessing of medical devices should be included in the assessment. You asked if it would be acceptable to have
one of your OR nurses conduct this assess- ment. If the nurse was a “healthcare profes- sional with expertise in device reprocessing” and had the professional sterile processing credentials then it might be acceptable to have them conduct the assessment. I am sure as a perioperative director you are aware there is nothing in the nursing curriculum which provides the necessary education in the special skills and knowledge required to be profi cient in sterile processing technology. It would be unfair and inappropriate to place one of your staff nurses in the position of having to conduct such an assessment, without the required education and expertise. There is no need or requirement for you to hire an outside consultant to do this assessment provided you have a qualifi ed, credentialed Sterile Process- ing professional on staff with the expertise. In accordance with the Association for
the Advancement of Medical Instrumenta- tion (AAMI) standards the sterile processing manager and supervisory personnel should be qualifi ed by way of proper education, cer- tifi cation and continuing education. I believe that any sterile reprocessing done throughout the healthcare facility should come under the direction and management the Sterile Pro- cessing Director. This would ensure the stan- dardization of proper reprocessing protocols throughout the organization. HPN
Ray Taurasi is Eastern Regional Director of Clinical Sales and Services for Healthmark Industries. His healthcare career spans over three decades as an Administrator, Educator, Technologist and Con- sultant. He is a member of AORN, AHA, SGNA, AAMI and a past president of IAHCSMM. Taurasi has been a faculty member of numerous colleges teaching in the divisions of business administration and health sciences.
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60
