Have you Validated your Instrument Cleaning Instructions?

There has been increased scrutiny on sterile processing departments regarding their practices for cleaning and sterilizing reusable surgical instruments and other medical devices.. The situation is complicated by the variances in many respects: the efficacy of the instructions for use (IFUs) among different manufacturers, the plethora of devices available on the market today with non-standardized cleaning protocols and the level of adherence to IFUs by sterile processing departments. Every day, healthcare facilities' sterile processing departments are tasked with reprocessing thousands of devices.[1] made by hundreds of manufacturers, and the consequences of improper reprocessing can be disastrous for patients, staff, clinicians, and their respective organizations.. [1]

IFUs are based on following the device manufacturer’s recommendations. However, is it enough for sterile processing departments to assume that these instructions will necessarily result in a clean and sterile devices being returned to the OR?

The onus is on manufacturers  to provide validated instructions for use with scientific evidence and testing to prove the safety and efficacy of a reprocessing process for a reusable medical device. Many existing IFUs rely heavily on assessing visual cleanliness – that is, they rely on sterile processing professionals to verify that no visible residue remains. However, such visual validation is insufficient as microorganisms invisible to the human eye and biofilm may remain on the surface. Thus, validation of cleaning instructions provides a scientific, evidence-based approach to support the safety and efficacy of the cleaning instructions provided in an instrument IFU.

Novo Surgical performed one such validation study for its Instructions for Use (IFU) with a leading national independent laboratory. These validated cleaning instructions provide reprocessing personnel with the necessary information and steps to safely and efficaciously reprocess Novo Surgical instruments with the confidence of laboratory-backed testing.. In addition to testing efficacy, the purpose of the validation study is to provide scientific evidence to verify the efficiency, understandability, comprehensiveness and replicability of the cleaning instructions described in Novo Surgical’ s IFU, even under ‘worst case’ scenarios. In our context, worst case scenario testing utilizes manual cleaning processes under the assumption that no automatic cleaning devices are available for use.

The cleaning validation was conducted by Nelson Labs® and done in compliance with the standards outlined in the FDA’s March 2015 Guidance Document titled Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling as well as in accordance with the AAMI TIR30:2011 Guidance Document.  Although this validation is not required by current FDA regulation for the existing products Novo Surgical currently offers in the market, the company nonetheless undertook the validation initiative as a part of its ongoing quality management efforts and to take a leadership position on this important industry issue,  This is particularly important in light of recent problems posed by reusable surgical devices including duodenoscopes that the FDA has determined contributed to post-surgical infections and even death. Part of the FDA’s findings include the failure of device manufacturers to properly validate the cleaning instructions for these problematic devices.

As a part of the validation study, three master samples with design features representative of most of Novo Surgical’ s product offering, including serrations, ratchets, ring handles and box locks, were chosen from Novo Surgical’s product line. The purpose of this was to ensure that the cleaning instructions were effective for the most common design characteristics.

During the study, the distal ends of the master samples were immersed and articulated in test soil and left to dwell at room temperature for an hour to simulate use and wait time prior to reprocessing. Normally instruments should be kept moist and immersed in an enzymatic bath immediately following surgery, but with worst case testing in mind, this was not done when testing the samples. Novo Surgical’s manual cleaning instructions were then followed, which consisted of manual flushing and brushing. Again, to simulate worst case scenario testing, the samples were not cleaned using any automated washer or ultrasonic equipment.

After being dried, the instruments were tested for contaminants including hemoglobin, BCA proteins and MEM Elution testing. The results of these tests were found to have met the acceptance criteria recommended in AAMI/ANSI/ISO standards TIR 30 and TIR 12, thus proving the effectiveness of Novo Surgical’s cleaning instructions.

Novo Surgical appreciates the opportunity to share this information. To request a copy of the validation report or the validated cleaning instructions, or to direct questions or concerns associated with this notice, please feel free to contact our customer service team at our corporate offices.



  1. Sterile Processing Department’s Role in Patient Safety, https://www.ecri.org/components/PSOCore/Pages/PSONav0812.aspx?tab=2 ECRI, 8/1/2012