It is common for facilities to struggle when trying to reduce SPD non-compliance rates in order to provide a higher quality of patient care. Based on data collected during surveys and reviews from January – December 31, 2014, The Joint Commission identified five areas where healthcare facilities most frequently fell out of compliance. One of those areas was the organization’s ability to reduce the risk of infections associated with medical equipment, devices, and supplies. Here is a summary of the 2014 statistics1:

Non-Compliance %                                        Facility Type
52%                                                                 Hospitals
41%                                                                 Ambulatory Care
51%                                                                 Critical Access Hospitals
39%                                                                 Office-Based Surgery

Now, over three years later, it’s more important than ever to do everything possible to reduce SPD non-compliance rates. Even for a facility that may only have a 5% non-compliance rate, there’s still room for improvement.

So where should a facility start?

To help with non-compliance, multiple regulatory agencies consistently emphasize several recommendations that all facilities should be following to help minimize a patient’s risk of surgical site infections from improperly reprocessed surgical instruments and devices. One such recommendation is proper utilization of IFUs, or Instructions for Use.

It might seem like common sense to follow IFUs, but it’s easy for department members to skip over them or assume they know every detail of an IFU without checking it first. That’s why every healthcare regulatory agency recommends or requires strict adherence to a Manufacturers’ Instructions for Use (IFUs), including The Joint Commission, AAMI, CDC, Centers for Medicare and Medicaid, AORN, and the FDA.

IFUs are important because:

  • Improperly processed instruments have been linked to patient injury
  • The manufacturer, in accordance with FDA and AAMI guidelines, is required to validate the steps necessary to prepare a device for safe patient use

The Joint Commission now requires that, during an audit, Central Sterile Supply Departments show current manufacturers’ IFUs as well as how they are used. The Centers for Medicare and Medicaid also check for the presence of manufacturers’ IFUs on the Infection Control Surveyor worksheet2.

As you consider your team’s current procedure on following IFUs, follow these best practices to set yourself up for success in seeing a reduction in defect rate.

  • Consider designating a seasoned staff member to be responsible for managing, updating, and educating staff on changes to manufacturers’ IFU documentation at the facility.
  • Use an online database service of manufacturers’ IFU documents such as oneSOURCE.
  • Contact your device manufacturer and request additional in-servicing and training.

Engage your facility’s Infection Preventionist to help identify and champion the department’s needs. Following the manufacturers’ IFUs is key to delivering a safe product for surgery and can be a big step toward improving patient safety. In order to emphasize this significant fact to your staff, incorporate the message into the department’s culture in an on-going manner.

So how is your facility measuring up? Whether IFUs are a daily part of your department’s work or an occasional thought during the daily bustle of work, every department and every staff member can benefit from improvement.

UDI Impact on Healthcare Facilities

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1 Joint Commission Online: Top five most challenging requirements for 2014, April 8, 2015. Accessible at: http://www.jointcommission. org/assets/1/23/jconline_April_8_15.pdf

2 Jagrosse, David. The Importance of Manufacturers’ Instructions for Use Documents, September 2014. Accessible at: http://www.njcl. us/images/Onesource_IFU_Sept_2014.ppt_1_.pdf