FDA ADVISORY
FDA Safety Communication on supplemental measures to enhance duodenoscope reprocessing
T
he Food and Drug Administration (FDA) has released a detailed list of supplemental duodenoscope repro- cessing measures that emerged from an agency-led expert panel meeting earlier this year. Hospitals and healthcare facilities that utilize duodenoscopes can, in addition to meticulously following manufacturer reprocessing instructions, take one or more of these additional steps to further reduce the risk of infection and increase the safety of these medical devices. The communica- tion includes all Endoscopic Retrograde Cholangiopancreatography (ERCP) endo- scopes (side-viewing duodenoscopes). The FDA recognizes that not all healthcare facilities can implement one or more of these measures, which require specific resources, training, and expertise. Therefore, it is critical that staff responsible for reprocess- ing duodenoscopes have the manufacturer’s instructions readily available to promote strict adherence to the reprocessing instruc- tions in the device labeling, understand the importance of their role in reprocessing the device, and maintain proficiency in perform- ing these reprocessing tasks. While the risk of infection transmission cannot be completely eliminated, the benefits of these devices con- tinue to outweigh the risks in appropriately selected patients.
For duodenoscopes, their unique and complex design improves the efficiency and effectiveness of ERCP, it also presents chal- lenges for effective reprocessing, notably: • Duodenoscopes are complex instruments that contain many small working parts. Proper cleaning and disinfection of the el- evator mechanism is of particular concern. The moving parts of the elevator mecha- nism contain microscopic, hard-to-reach crevices. If not thoroughly cleaned and disinfected, tissue or fluid and residual bacteria from one patient may remain in device crevices of a duodenoscope, expos- ing subsequent patients to risk of infection.
• Meticulous adherence to the manufac- turer’s reprocessing instructions is labor intensive and prone to human error. It is critical that staff responsible for reprocessing duodenoscopes have the manufacturer’s instructions readily avail- able to promote strict adherence to the reprocessing instructions in the device labeling, understand the importance of
their role in reprocessing the device, and maintain proficiency in performing these reprocessing tasks.
• The FDA is aware of instances of per- sistent bacterial contamination even fol- lowing strict adherence to manufacturer reprocessing instructions. Because of this, FDA recommends that facilities and staff that reprocess ERCP duodenoscopes es- tablish and implement a comprehensive quality control program for reprocessing duodenoscopes. At an expert panel meeting, representa- tives from several healthcare facilities and the panel discussed additional strategies that have been implemented to reduce the risk of infection transmission. In each case, staff applied these supplemental methods in addition to meticulous cleaning as part of strict adherence to the manufacturer’s reprocessing instructions, as recommended in previous FDA Safety Communications. Furthermore, these measures may not be feasible in all healthcare facilities and each of these options comes with its own benefits and limitations.
Supplemental measures for facilities and staff that reprocess duodenoscopes to consider: Combined with strict adherence to the duodenoscope manufacturer’s reprocessing instructions, the following supplemental measures may further help reduce the risk of infection transmission associated with the use of duodenoscopes: • Microbiological Culturing • Ethylene Oxide Sterilization • Use of a Liquid Chemical Sterilant Processing System
• Repeat High-Level Disinfection The FDA recommends healthcare facilities performing ERCP evaluate whether they have the expertise, training and resources to implement one or more of these options:
Microbiological culturing of duodenoscopes Microbiological culturing involves sampling duodenoscope channels and the distal end of the scope and culturing those samples to identify any bacterial contamination that may be present on the scope after repro- cessing. Some facilities have successfully implemented routine or periodic surveillance
44 September 2015 • HEALTHCARE PURCHASING NEWS •
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culturing to assess the adequacy of duodeno- scope reprocessing and to identify duodeno- scopes with persistent contamination despite reprocessing. In March 2015, the Centers for Disease Control (CDC) released an Interim Duodenoscope Surveillance Protocol that includes duodenoscope sampling and cul- turing protocols, which may be used as a guide for healthcare facilities to assess the adequacy of their duodenoscope reprocess- ing. This interim protocol includes several options for duodenoscope culturing based on the resources and requirements of each healthcare facility. One option is to culture duodenoscopes after every reprocessing cycle and to quarantine the duodenoscope until culture results are known. Another op- tion is to culture at intervals defined by the healthcare facility, i.e., weekly, monthly or after a fixed number of procedures. The CDC’s interim duodenoscope surveil- lance protocol is a good tool; however, the false positive rate, the false negative rate and the limits of detection for microbial surveil- lance have not yet been established for this method. Nevertheless, persistent duodeno- scope contamination as defined in the interim surveillance protocol should lead to action by the healthcare facility, such as taking the scope out of circulation until negative culture results can be demonstrated following repeat reprocessing.
Healthcare facilities evaluating the poten- tial implementation of duodenoscope micro- biological culturing following duodenoscope reprocessing should consider the following: • Any duodenoscope found to be contami- nated should not be returned to use until the contamination has been eliminated from the device.
• Microbiological culturing is resource- intensive and includes added costs of mi- crobiological testing and staff time needed to collect and process samples.
• Some healthcare facilities have “out- sourced” duodenoscope culturing to envi- ronmental or contract laboratories due to lack of on-site experience with culturing, uncertainty in interpretation of results and workflow considerations.
• Surveillance culture results take time to produce. When duodenoscopes are cul- tured after every reprocessing cycle, the duodenoscope is typically quarantined and
FDA ADVISORY
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