He not only believes in the importance of collaboration between manufacturers and CS/SPDs, but also the need to teach tech- nicians the validation process behind an IFU’s development. Furthermore, he urges manufacturers to hire CS/SPD profession- als to advise them on their IFUs, and even help write them. “Companies tend to write their IFUs

from the perspective of needing to pass validation to obtain FDA clearance, and not necessarily with the end user in mind,” said Flynn. “I find that sales reps are not always the best subject matter experts to provide detailed in-services relating to how a device was validated because they gloss over how the cleaning parameters were chosen — technicians learn how to clean it but they really don’t get the ‘why’ piece. I feel it is extremely important for techs to know why they are doing what they are doing when it comes to processing devices. That way, if they are tempted to skip over a particular step they will think twice because they understand how that action will impact the device, end user and patients downstream.”

IFU accessibility Obviously there are challenges to under- standing and following IFUs — but what if you can’t find them to begin with? Ac- cording to manufacturers and CS/SPD professionals alike, IFU accessibility is critical to success. “Access has become crit-

ically important with the increased emphasis that sur- veyors have placed on IFUs, where they are coming into facilities and asking techni- cians for copies of them,” said Mary Ann Drosnock, MS, FAPIC, CIC, CFER, RM (NRCM), Man- ager, Clinical Education for Endoscopy, Healthmark Industries. Chuck DePreker, CRCST, CHM, CIS,

Mary Ann Drosnock

Lead Supply Chain Manager for the OR and SPD at Eisenhower Army Medical Center, started his healthcare career in the Army, training as an OR technician with cross training in sterile process- ing. It was at this time that he realized the importance of IFU access. In an effort to improve the ability for techni- cians to access IFUs, DePreker uploaded PDF versions of the IFUs to a folder on a Microsoft SharePoint site. Today his facil- ity, like many others, uses the oneSOURCE Document Management Service. According to Heather Thomas, VP of Sales and Marketing for oneSOURCE,

Chuck DePreker

the service makes health- care facilities’ compliance with accreditation standards easy by eliminating the ex- pense of maintaining and updating IFU documents and manuals, and by making these documents easily accessible online to every department within the facility.

Heather Thomas

“Access to IFUs is a must and definitely

a Joint Commission audit target,” said DePreker. “If your facility is involved in a malpractice suit the lawyer representing the patient is likely going to pull out that IFU. If you are working in the CS/SPD and don’t have access to them then you are dead in the water. We even require vendors to in- clude their IFUs when they bring in loaner trays, even though we can get them through oneSOURCE, because I believe a rep should always have their IFUs readily available.” Huether (Methodist) notes how easy ac-

cess to IFUs can help empower technicians to make the right choices. He provides the following example: “One of the techs came up to me and

said that she pulled a random IFU because she wanted to know if she was properly processing a certain brush. She discovered we were not putting this particular brush in the sonic when we should have been according to the IFU — just for a short period of time. I told her that was a great catch and thanked her for bringing it to our attention. We decided to switch to a different brush that could go through the washer. In cases such as this, the IFU is beneficial because it can increase morale and staff productivity.” “Regardless of whether the process is manual or managed with a software solu- tion, IFU records should be audited on a regular basis and updated accordingly,” said Poulin. “The audit should also include a cross reference to the instrument database to ensure that the entire inventory has a corresponding IFU. Updates can also be tracked on the same spreadsheet as the instrument database.”

A final word on scopes An entire article could be written on IFUs for scopes, including whether scope manufacturers have issued revised or updated IFUs in recent years, after the string of illness and death attributed to hard-to-clean scopes. When asked about this topic, Cynthia Spry, MA, MS, RN, CNOR(E), CSPDT, Consultant, responded: “Absolutely, endoscope manufacturers have modi-

Cynthia Spry


fied or revised instructions for use as a result of patient injury or infection related to inadequate cleaning, because design changes have been made or because new evidence identifying best practice has emerged. We have already seen scope design changes intended to ensure better cleaning and research into scope process- ing is ongoing and will undoubtedly result in additional IFU revisions. I am confident that not only will existing instructions change but also that single-use scopes will become part of endoscopy department inventories. Improvements in single-use scopes, particularly the optics, make them an attractive alternative for use in specific procedures or for use on selected patients.” “Olympus takes its role in protecting

patient safety very seriously, and we are continuously seeking to improve the next generation of our products, provide guidance on their safe and effective use and increase the ease and efficacy of endoscope reprocessing,” said Nadine Clark, Director of Marketing, GI Scopes & Procedures, Olympus. “We have allocated up to 15 percent of our Research & Devel- opment headcount to focus on enhancing product safety of our endoscopes. We are continuing to develop next- generation products that will further enhance reprocessing operability and healthcare procedures through many potential changes such as product design, component materials and reprocessing methods.” “Since 2015 in the United States, we have provided grants of more than $740,000 and in-kind contributions of more than $1.7 million for research into reprocessing and infection control,” she added. “We have also performed more than 8,425 educational and training site visits to more than 2,500 customer sites, provided new instructions for cleaning and disinfection of duodenoscopes, and introduced a new cleaning brush and instructions for its use. Additionally, we continue to develop materials for our customers to help guide proper reprocessing. We will continue to work with customers, medical societies, governments and other stakeholders to seek to deliver the best and safest products to market.” HPN

Nadine Clark


1. Reprocessing Medical Devices in Health Care Settings: Valida- tion Methods and Labeling, Guidance for Industry and Food and Drug Administration Staff, March 17, 2015, http://www.fda. gov/downloads/medicaldevices/deviceregulationandguidance/ guidancedocuments/ucm253010.pdf

2. ANSI/AAMI ST90, Processing of health care products—Quality management systems for reprocessing in health care facilities, July 18, 2017, ProductDetail.aspx?ItemNumber=4913

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