FDA continues focus on reprocessing instructions As the FDA has noted in their Safety Communi- cations, the complex design of duodenoscopes may impede effective reprocessing. Reprocess- ing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. The FDA has been working with duodeno-

scope manufacturers as they modify and vali- date their reprocessing instructions to further enhance the safety margin of their devices and show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes. In February 2016, Pentax issued updated,

validated manual reprocessing instructions for the ED-3490TK Duodenoscope to replace those provided in the original device labeling. The FDA reviewed these updated reprocessing instructions and the validation data and contin- ues to recommend that facilities using Pentax ED-3490TK duodenoscopes train staff on the updated instructions and implement them, if they have not already done so. In January 2017, Pentax informed custom-

ers about a potential issue associated with the distal cap of the ED-3490TK and began a program to inspect all customers' ED-3490TK duodenoscopes. On February 7, 2018, Pentax issued an Urgent Medical Device Correction and Removal notification informing customers of its voluntary recall of all ED-3490TK duodeno- scopes in order to replace the forceps elevator mechanism, O-ring seal and distal end cap, and to update the Operation Manual to recommend annual maintenance. The design changes are intended to reduce

the potential for leakage of patient fluids into the closed elevator channel and under the distal cap. The FDA cleared the updated design and labeling for the ED-3490TK on February 7, 2018. The reprocessing instructions for the recently cleared ED-3490TK have not changed since the February 2016 update. The FDA continues to closely monitor the as-

sociation between reprocessed endoscopes and the transmission of infectious agents. Based on currently available information, the

FDA recommends healthcare facilities: • Acknowledge Pentax’s Urgent Medical Device Correction and Removal notification disclaimer icon and identify affected products in your facility.

• Indicate if you do NOT have any affected duo- denoscopes or Operation Manuals.

• Upon receipt of the new Operation Manuals, remove and dispose of any older operation manuals in your facility.

• Be aware of the manual reprocessing proce- dures outlined in FDA’s January 17, 2017, Safe- ty Communication “UPDATE: Importance of Following Validated Reprocessing Instructions for Pentax-ED-3490TK Video Duodenoscopes.”

The pitfalls and triumphs of IFUs

by Kara Nadeau I

nstructions for use (IFU) is a hot but- ton topic among those who develop them — device manufacturers —

those who use them — central sterile/ sterile processing (CS/SPD) profession- als — and many others involved in the life cycle of medical devices — surgeons, operating room (OR) staff, materials managers, etc.

IFUs is a topic that many people love to hate. There is also some amazing work be- ing performed by manufacturers, CS/SPD professionals and others in the healthcare industry to improve IFU usability and accessibility. These parties recognize that IFUs as they currently stand are at best a source of frustration, and at worst a threat to patient safety.

Michele DeMeo, CSPDT, CRCST, Inde- pendent CS/SPD Consultant at MDD Virtual Consult- ing, stated: “This is such a complex topic for a single article. In fact, books could be written on the subject of IFUs for devices, instru- ments, processors and other

Michele DeMeo

technologies or sets. It is simply a topic with few boundaries.” Healthcare Purchasing News explores in-

dustry efforts to standardize IFU formats, the need for IFU validation, the latest industry guidance for the CS/SPD, and present real-world challenges and best practices from CS/SPD professionals.

IFU standardization: a collaborative effort Since the Food and Drug Administra- tion (FDA) issued its 2015 guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Guidance for Industry and Food and Drug Administration Staff,1

manufacturers, CS/

SPD professionals and others have been working on ways to improve IFUs. The guidance states that manufacturers must provide customers with IFUs that describe in detail “instructions for a reprocessing method that reflects the physical design of the device, its intended use, and the soiling and contamination to which the device will be subject during clinical use.”1


What’s interesting is that some of the parties that have been tackling the IFU challenge independently have discovered they have been working toward a very similar solution.

“It is not that IFUs were not important years ago, they were and also a require- ment to follow, even ‘back then,’” said DeMeo. “The difference, unfortunately, was that little attention was given to them by too few facilities. In addition, even less attention was placed to not only every aspect of the IFU, but also its relationship to the total process and practices and pro- cessors used to decontaminate, assemble, sterilize, store then re-use the item(s).”

A CS/SPD approach

In 2014, Jack LeClair, RN, CSPDT, Re- gional Director, System Services, Director of Operations, Sterile Processing Depart- ment, Memorial Hermann Healthcare System, decided to tackle the variability and complexity of IFUs in an effort to simplify cleaning processes for his department’s technicians. LeClair first went through IFUs for the products his de-

Jack LeClair

partment was responsible for processing and categorized them into what he calls “families” based on their cleaning require- ments. For example, those with the least complex designs (which LeClair refers to as “knife and fork type instruments”) were assigned to class one. LeClair progressed through more complex instruments and in the end had designated eight categories of devices.

Next, he took the “worst case cleaning scenario” for each category of instrument — those that required the most effort to clean — and used that as the basis of the cleaning protocol for that category. LeClair is now working to integrate the protocols into Memorial Hermann’s in- strument tracking system so that when a technician scans a tray the system will display the correct cleaning protocol.

A manufacturer’s approach

Joan Spear, RN, MBA, CNOR, CRCST, CSPDT, is a Clinical Consultant for sterile

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