said Schule. “Structured education, training and competency programs to verify a technician’s ability to follow established processes to achieve quality product is essential. We have a significant opportunity to get the word out and see to it our CS/SPD leadership is aware these standards exist and deployed when processing modalities dictate.”

Efforts to address test soils

Another effort underway to categorize and standardize IFUs is the ASTM International Task Group on Cleanli- ness of Biomedical Devices (F04.15.17). According to Justin Poulin, Clinical Operations Executive for Northfield Medical, the group is currently drafting testing methods that will help manufacturers meet AAMI and FDA guidelines. The goal is to develop a standard guide for selecting test soils when obtain- ing cleaning validation for new devices based on the intended clinical use. Further, the task group is developing specific testing protocols and corresponding cleaning methods for removing test soils in the cleaning validation process. “Standardizing the IFU format and requirements while de- creasing variability would be a big step in the right direction to ensure that critical cleaning and sterilization parameters are followed consistently to the benefit of the patient,” said Poulin.

Justin Poulin

The real world: challenges and best practices from the CS/SPD Although the industry is working to improve IFUs from many angles, it is important to understand how CS/SPD profession- als are using current IFUs to deliver safe and effective products to clinicians.

Storage solutions for sterile processing departments (SPD)

Manufacturer collaboration Most manufacturers are unlikely to change IFUs for existing products on their own, therefore some CS/SPD leaders have taken it upon themselves to approach manufacturers with alternative processing steps that better meet the real-world operations of their departments, while yielding the same results.

Loraine Durigan, CRCST, CHL, CIS, Materials Manager and CS Supervisor, Florida Hospital, conducted a trial on one manufacturer’s saws and drills and found it took 40 minutes to sterilize these items according to the IFU. She approached the company and discovered the only reason why they recommended 40 minutes was because this was their European sterilization parameter so they copied and pasted as the param- eter for the US.

Loraine Durigan

“Our department follows the manufacturer IFUs to a T but we

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are also the first ones that will go back to a company and tell them — ‘this is too much you have to revise it,’” said Durigan. Albert Huether, Director of the Sterile Processing Department at Methodist Healthcare System, San Antonio, notes how his team builds relationships with their manu- facturers so that anytime there is an update to an IFU the rep lets them know immediately. “It is extremely vital to get the reps involved be- cause this is their product,” said Huether. “If there is an urgent change — a shift where processes may be effected — we ask the rep to come in and service our staff ASAP. This collaborative relationship benefits both sides.” According to Huether, Methodist Healthcare System is a heavy user of robotic surgical systems. They currently have six systems in place and are in the process of purchasing another. Their rep for these products recently alerted Huether and his team to some IFU changes that would help improve processing turn around time. “He sent me an email so that we could immediately implement the change and provided updated posters that featured step by step instructions on how to clean and prep the robotic arms,” said Huether. “Because they are such a difficult item to process in general, we also have a consensus with our staff where they will reach out to me if they don’t understand the IFU.” “IFUs are the road map to successful reprocessing of medical devices and end users are putting pressure on their vendors to provide IFUs with new medical devices often times before the device even arrives at the facility to ensure that it can be reprocessed,” said Lindsay Brown, Clinical Education Manager, Key Surgical. “Because of this, vendors should adhere to a more formulaic model for IFUs in order to maintain good working re- lationships with their customers and continue to meet their needs. End users understand how critical these instructions are and a lack of information from the manufacturer will eventually be detrimental to that partnership.”

Albert Huether

Lindsay Brown

Understanding the science of IFUs

Shawn Flynn, CRCST, CIS, CHL, Manager, Sterile Processing/OR Services, Stanford Children’s Health, Lucile Package Children’s Hospital, has experience with IFUs from both the manufacturer and end user perspectives. He has served as a CS/ SPD manager and interim director, CS/SPD con- sultant and also started his own medical device company.

He explains how CS/SPD professionals typically approach IFUs from an instructional and compli- ance perspective, with a limited window into the manufacturing, validation and regulatory process.

Shawn Flynn

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