Current articles concerning the need for cleaning and sterilization validation:

Healthcare Purchasing News (HPN), November 2016

The November 2016 issue of Healthcare Purchasing News (HPN) published two important articles on the critical need for validation:

Manufacturer IFUs can stray from validation: 
SPD staff, patients suffer from lack of quality assurance 
(Link to online story) (Download PDF)

By James Schneiter – October 20, 2016

The most misunderstood and overlooked aspect of any reusable device manufacturer’s instructions for cleaning, disinfecting and sterilizing their product is whether those IFUs have been validated.

The single most dangerous mistake that healthcare personnel make is when they purchase difficult-to-clean reusable medical devices (e.g., endoscopes, laparoscopic instruments, Kerrison Rongeurs, etc.) whose IFUs have not been validated. If you purchase reusable medical devices without first checking to ensure that the cleaning IFUs have been validated using Food and Drug Administration (FDA) validation protocols, you are increasing the risk of patient harm caused by instruments that are difficult, if not impossible, to thoroughly decontaminate, clean and sterilize.

If a reusable device’s IFUs have not been validated, you can meticulously follow all of the steps on the IFUs that come with the product, and you will still not have the assurance of clean, sterile, moisture-free devices after every reprocessing cycle.

Non-validated IFU consequences

First, numerous outbreaks of Carbapenem-resistant Enterobacteriaceae (CRE) causing patient harm and patient deaths during the past few years have been attributed to endoscopes whose cleaning IFUs had not been validated. As a result of these patient deaths, the FDA in August 2015 cited Pentax and Fujifilm1 for failing to make sure their instructions for cleaning the scopes were valid.

Second, if you use devices that have not been validated, you are placing your patients at risk due to bioburden and biofilm remaining in the device after cleaning. A recent investigation by The Detroit News found that midtown hospitals of the Detroit Medical Center (DMC) have struggled for years to properly clean surgical instruments, stoking doctors’ fears about patient safety. One newspaper quote: “Doctors are concerned because old blood and bone, even when sterilized, are biohazards that can trigger infection, septic shock and even death if they come into contact with patients.”2

The fears over patient safety from devices that are difficult to reprocess led the FDA to issue new requirements in March 2015 that specifically require medical device manufacturers to “validate” their cleaning IFUs. On page 22 of the FDA publication, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff,” the third paragraph states, “For class II and class III devices and select class I devices, manufacturers must establish and maintain procedures for validating the design of their device, which shall ensure that the device conforms to defined user needs and intended uses, 21 CFR 820.30(g). Manufacturers must also establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met, 21 CFR 820.75(b). Establishing procedures includes implementation, 21 CFR 820.3(k). FDA interprets these regulations to require manufacturers to validate the design, including reprocessing instructions, of reusable devices to ensure that the device can be effectively reprocessed and safely reused over its use life, as intended.

Third, there are now several lawsuits, most notably at Lutheran General Hospital in Park Ridge, IL, where the hospital is being sued by a deceased patient’s family for using a reusable medical device whose cleaning IFUs had not been validated.3 More than 38 patients became infected with CRE at Lutheran General from contaminated scopes. Hospital personnel were meticulously following all of the decontamination and cleaning steps on the IFUs that came with the product, but the scopes were still contaminated after reprocessing.4 As this case tragically demonstrates, following a manufacturer’s IFUs that have not been validated does not ensure against patient harm.

Fourth, while following a manufacturer’s cleaning IFUs is always a good idea, if the manufacturer’s IFUs have not been validated using FDA validation protocols, there is no way to ensure clean, sterile, moisture-free instruments, regardless of how thorough the reprocessing effort. The documented patient harm caused by devices whose IFUs had not been validated at facilities like Lutheran General and Virginia Mason5 in Seattle, WA, is just the tip of the iceberg. Many of these deadly infections are caused by contaminated instruments whose cleaning IFUs have never been validated. Without independent validation of a device’s cleaning IFUs, reprocessing personnel do not have the ability to ensure clean, sterile, moisture-free instruments for every patient.

As Healthcare Purchasing News noted in a May 2016 editorial column:

To ensure device cleaning, disinfection and sterilization effectiveness, SPD staff should use validated IFUs provided by manufacturers.
Device manufacturers should provide validated IFUs to their healthcare organization customers so they know how to clean, disinfect and sterilize products effectively to prevent patient infections from improperly reprocessed devices.
The FDA stipulates in its guidelines that device manufacturers validate the design, functionality and end-user operation of the devices they make, including reprocessing instructions.
The HPN editorial went on to state that “Supply Chain and SPD pros (and GPOs) must demand that any and all devices and products include authentically validated IFUs as a requirement for contract consideration or they won’t be acquired.”6

Written, not verbal, validation

Another commonly misunderstood aspect of a device manufacturer’s IFUs is accepting a sales representative’s verbal assurance that his company’s IFUs “have been validated.” Unless you request the sales representative to provide you with a copy of their validation report using FDA validation protocols, you have no assurance of clean, sterile, moisture-free instruments. Why would you continue to risk harming your patients by not requesting a copy of the manufacturer’s validation report for their IFUs?

A frequently made mistake is to believe that a manufacturer’s IFUs have been validated just because their IFUs on the company website uses the word “validated.” Unless the manufacturer has validated its IFUs by following the FDA’s validation protocol, those IFUs have not been validated.

The new FDA validation requirements for device manufacturers are very specific regarding the validation of processes designed to clean reusable medical devices. As stated on page 23 of the FDA publication “You (the device manufacturer) should validate the cleaning process you provide in your labeling. Your validation activities should be based on comprehensive validation protocols that use soils that are relevant to the clinical use conditions of the device. These should include the worst-case (least rigorous) implementation of the cleaning process, medical devices that represent the worst-case (most challenging to reprocess and most contaminated). These protocols should be designed to establish that the most inaccessible locations on your devices can be adequately cleaned during routine processing.”

When a manufacturer of reusable devices tells the hospital that “our instruments have been validated,” and yet they have not followed the FDA’s validation protocol, all they are really saying is that the sterilization indicator worked when their instruments were run through a sterilizer. Prior to sterilization, their “test” instruments were not immersed in bioburden and then allowed to dry in the air to simulate the normal wait time between contamination and the start of reprocessing. Their non-contaminated instruments were simply placed into a sterilizer and then run through a normal sterilization cycle. After emerging from the sterilizer, the instruments were not cultured for the presence of biofilm, nor were they inspected for the presence of bioburden or residual moisture. The only thing ‘validated’ was that conditions were right (time, pressure, temperature and steam) to turn the sterilization indicator.

The last, and perhaps biggest, mistake people make is using instruments that have to be disassembled during reprocessing, or “modular” instruments, who’s IFUs rely on “visual verification” to ensure the removal of bioburden and biofilm. Visual verification is not an acceptable substitute for using instruments who’s IFUs have been validated. That is because the human eye cannot see microscopic bioburden, nor can it see biofilm, making “visual verification”’ physically impossible! Being able to “visualize” the inside of the instrument does not ensure a clean instrument (assuming that reprocessing personnel even remember to take the time to disassemble, manually clean and then properly reassemble the instrument). The only way to ensure clean, sterile, moisture-free instruments on every reprocessing cycle is to only use instruments who’s IFUs have been validated using FDA validation protocols.

Failure to demand validated cleaning IFUs from device manufacturers is a tremendous patient safety issue. Healthcare facilities have a legal, ethical, financial and moral obligation to use only instruments whose IFUs have been validated using FDA validation protocols. HPN


1,“FDA issues warning to scope makers over spread of deadly superbugs,” (MPS On-Line, 8/18/15).

2. “Dirty, missing instruments plague DMC surgeries,” The Detroit News, August 26, 2016, by Karen Bouffard and Joel Kurth.

3. “Tainted Scope Leads to Death, Lawsuit,” (Surgical Products, September 3, 2015).

4. “Superbug found at suburban hospital, Lutheran General, health officials taking steps to prevent spread of CRE,” Chicago Tribune, January 10, 2014, by Robert McCoppin and Cynthia Dizikes.

5. “Virginia Mason joins with ‘superbug’ widow to sue scope-maker,” The Seattle Times, May 11, 2015, by JoNel Aleccia.

6. “The V Word,” Healthcare Purchasing News, May 2016, by Rick Dana Barlow.

Narrating the pathogenesis of a deep organ surgical infection
(Link to online story) (download PDF)

By James Schneiter – October 20, 2016

When dead, sterile bioburden gets deposited into the body from a contaminated instrument during a surgical procedure, the foreign, organic material begins to decompose and is attacked by phagocytes. Phagocytes are the white blood cells that protect the body from harm by ingesting (phagocytosing) harmful foreign particles, including dead, sterile, organic cells. Part of this process involves the production of lysozymes that break down the cell walls of the dead, sterile, organic material. Frequently, those cell walls contain endotoxins that are then released into the blood stream.

As the body tries to fight the dead, sterile, organic bioburden with a rapid increase in the production of lysozymes, you also see an increase in body temperature due to the infection caused by the release of the bacterial toxins. This process is frequently seen in surgical patients who present with a fever of unknown origin and an elevated white blood cell count within 24-48 hours of surgery.

The real danger caused by the release of endotoxins from the dead, sterile, organic cells is the body’s response to the endotoxins. Once detected in the bloodstream, endotoxins stimulate cytokine production. The rapid production of cytokines can trigger the systemic inflammatory response syndrome that can potentially cause multiple system organ failure. An intra-abdominal infection following abdominal surgery is one of the most common causes of multiple system organ failure.

If dead, sterile bioburden gets deposited into the body of a patient whose immune system is suppressed or compromised, the consequences can be much more severe. If bacterial toxins are released into the bloodstream of a patient whose immune system cannot rapidly produce white blood cells, septic shock is a possible consequence of the bacterial toxins in the bloodstream.

For examples, see the five photos here. Please understand that these are photographs of reusable instruments (not instruments that have to be disassembled during reprocessing) that were disassembled after being reprocessed. The Kerrisons were disassembled for sharpening by an instrument repair technician. Had they not been sent out for sharpening, they would have been used on the next patient!

The same is true of the photos of the laparoscopic instruments. I disassembled them during some of my research into bioburden and instruments years ago. Regretfully, nothing has changed in the ensuing years.

Please note that the residual bioburden inside of these instruments is not the fault of SPD personnel. The fault resides with the poor design of the instruments (internal square shoulders, long channels, multiple corners and internal dead spaces that collect and trap bioburden). During the normal opening and closing of these instruments during a case, some of that trapped bioburden can fall out of the instrument and cause an infection.

Given the inherent design flaws in these instruments, they can be difficult, if not impossible, to thoroughly decontaminate and clean during the reprocessing cycle, even if being reprocessed by extremely dedicated personnel. In the absence of validated IFUs to prove that instruments can be thoroughly decontaminated, cleaned and sterilized, you will continue to see instruments like these being returned to surgery on a daily basis and infecting innocent patients.

Healthcare Purchasing News (HPN), May 2016

The May 2016 issue of Healthcare Purchasing News (HPN) has a very powerful piece on the need for validated cleaning IFUs for all of your surgical instruments (

CDC Issues Health Alert Advisory on IFUs

The September 11, 2015 Health Alert Advisory (HAN00323) from the CDC states:

“The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) are alerting healthcare providers and facilities about the public health need to properly maintain, clean, and disinfect or sterilize reusable medical devices. Recent infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety. Healthcare facilities (e.g., hospitals, ambulatory surgical centers, clinics, and doctors’ offices) that utilize reusable medical devices are urged to immediately review current reprocessing practices at their facility to ensure they (1) are complying with all steps as directed by the device manufacturers, and (2) have in place appropriate policies and procedures that are consistent with current standards and guidelines.”

In view of this new Alert from the CDC, healthcare facilities should ask their current instrument representatives/suppliers for a copy of their cleaning IFUs that have been validated by an independent laboratory using AAMI and ANSI validation protocols.

When it comes to requesting validated IFUs from instrument manufacturers, Linda Clement, a consultant in sterile processing for STERIS Corporation warns hospital personnel, “Be sure the manufacturer understands you are asking for more than just cleaning instructions (IFUs). You must have the independent laboratory verification that those instructions actually work for cleaning the instrument.”

The IFUs for all AIM Clear Flush® instruments have been validated by independent laboratory testing* using AAMI and ANSI testing protocols to ensure clean, sterile, moisture-free instruments for every patient, every time!

*Nelson Laboratories and Midbrook Biomedical Cleaning Validation reports

FDA issues warning to medical device makers over failure to validate cleaning IFUs  (MPS On-Line, 8/18/15)

The Food and Drug Administration sent warning letters last week to three medical device manufacturers whose endoscopes have been blamed for spreading deadly bacteria. This is the agency’s strongest regulatory action yet since outbreaks in Los Angeles, Seattle, and elsewhere made headlines earlier this year.

The devices, made by Olympus, Pentax, and Fujifilm, are used in hundreds of thousands of procedures each year. The FDA says the companies failed to report problems with the scopes as required by law and in some cases failed to ensure that the devices could be adequately cleaned. Olympus and Pentax were specifically cited for failing to relay to FDA reports that their devices ”may have caused or contributed to a death or serious injury” within 30 days of learning about the event. Pentax and Fujifilm were cited for failing to make sure their instructions for cleaning the scopes were valid.

Read the full FDA Final Guidance on Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Source: FDA.

From the American Journal of Infection Control, May 2013:

“Indeed health care facilities have struggled with getting clear and effective cleaning instructions from device manufacturers. This issue with inadequate cleaning instructions for medical devices in health care has prompted the development of a draft FDA guidance document entitled “Manufacturers to validate cleaning instructions” (

“In addition, there have been a number of FDA and FDA/Association for the Advancement of Medical Instruments (AAMI) symposia specifically targeting the role of cleaning in medical device reprocessing. The spring 2011 AAMI/FDA summit was summarized in a document identifying what the key issues were with respect to cleaning of medical devices. This was followed by the fall 2011 AMMI/FDA summit that led to the Horizons spring 2012 issue publishing a number of articles outlining the problems associated with difficult to clean medical devices.”

Read the full article online: Monitoring and improving the effectiveness of cleaning medical and surgical devices

From a JAMA study, September 2013:

According to the JAMA report, “surgical site infections contribute the most to overall costs, accounting for more than a third of the total. Individual cases of surgical site infections added an average of $20,785 to a patient’s medical bills.

The authors of the JAMA study suggested that “a better understanding of the costs of such infections could help health care providers and payers justify investing more in prevention.”

The single most important ‘investment’ a hospital can make to reduce their patients’ risk of a surgical site infection is to invest in surgical instruments that have been validated to provide clean, sterile, moisture-free instruments on every reprocessing cycle. Given this new data contained in the JAMA report, the time has come for hospitals to require all of their instrument suppliers to provide cleaning and sterilization validation test results that were conducted by an independent laboratory (i.e., Nelson Labs). This testing and validation should be conducted using AAMI, FDA and ANSI cleaning and sterilization testing protocols. Without this level of documented testing, it is difficult, if not impossible, to ensure clean, sterile, moisture-free instruments on every reprocessing cycle for every patient.

See the full CBS News report: Study: Hospital infections cost $9.8 billion a year

Read the JAMA abstract: Health Care–Associated Infections: A Meta-analysis of Costs and Financial Impact on the US Health Care System

From The AORN Journal, Nov. 2013:

Abstract of “Uphill Grime: Process Improvement in Surgical Instrument Cleaning”:

After its investigation of cross-contamination from arthroscopic shavers, the US Food and Drug Administration issued an alert to hospitals about medical device reprocessing methods. In response to this, a team of risk management and instrument room personnel at a university hospital undertook a project that tested the manufacturer’s recommended cleaning methods for surgical instruments with the objective of determining the efficacy of automated instrument reprocessing and identifying a process that would produce a verifiably clean instrument after the cleaning process is performed. The quality improvement project focused on suction tips because they are used in most surgical procedures, are exposed to high levels of organic debris, and are difficult to clean. A variety of suction tips were cleaned and tested with a variety of processes and products to determine best instrument cleaning practices. Results of the project were eye-opening—debris was found where debris should not be, and the manufacturer’s recommended cleaning methods—the current practices—were not effective. 

Read the original article: Uphill Grime: Process Improvement in Surgical Instrument Cleaning

From the Chicago Tribune, Jan. 10th, 2014:

So far, Advocate Lutheran General Hospital in Park Ridge has identified 38 patients who have tested positive for an emerging strain of carbapenem-resistant enterobacteriaceae, or CRE, which are bacteria that are resistant to a class of antibiotics used as a last-resort treatment for seriously ill people.

Based on what happened at Lutheran General, which properly followed sanitizing protocols, federal and state agencies now are investigating whether there needs to be a change in how such scopes are sterilized between procedures.

The manufacturer of Lutheran General’s endoscopes, Pentax Medical Co., requires high-grade disinfection of the equipment, washing them and treating them with enzymatic and anti-bacterial cleaners, which hospital workers had done, Kelly said.

This tragic story points out why the FDA, AAMI, Joint Commission, AORN and the CDC are ALL pushing for the validation of manufacturers’ Instructions For Use (IFUs). I’ve known the head of the sterile reprocessing department at Lutheran General for years and he is heartbroken over the 38 patients who are infected with CRE (which is typically fatal for half of the patients who contract the disease). He is also very angry……..angry that he and his department followed the manufacturer’s IFUs precisely and the instruments still contained infectious bioburden after thorough reprocessing.

If the manufacturer’s IFUs have not been validated by an independent lab using AAMI and ANSI cleaning and sterilization testing protocols, SPD personnel can be doing everything right, but still have contaminated instruments going back into the O.R. and infecting patients.

When it comes to laparoscopic instruments and Kerrison Rongeurs, only the patented Clear Flush® instruments have had their IFUs validated* using AAMI and ANSI testing protocols. With the unique Clear Flush® technology, hospitals can have the documented confidence of clean, sterile, moisture-free instruments for every patient, every time!

*Nelson Laboratories Cleaning and Sterilization Validation Reports available at

Read the original article: Superbug found at suburban hospital

From “Biofilm in Device Reprocessing,” by Dr. Michelle Alfa:

“Biofilm In Device Reprocessing” by Dr. Michelle Alfa, Medical Director, Clinical Microbiology, Diagnostic Services of Manitoba, Winnipeg, Cananda

From the FDA Draft Guidance, May 2, 2011:

Draft Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

I. Introduction

When final, this guidance will supersede Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance. This draft guidance document updates and clarifies the recommended content of, and review procedures for, premarket notification submissions [510(k)], premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, and investigational device exemptions applications (IDE), concerning the labeling instructions for reprocessing reusable medical devices. In addition, this draft document provides more detail about FDA’s recommendations for the validation of processes intended to support reprocessing.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

II. Background

In recent years, there has been a significant advance in knowledge and technology involved in reprocessing reusable medical devices. Additionally, there has been an evolution towards more complex reusable medical device designs that are more difficult to clean and disinfect or sterilize. The revision of this guidance reflects scientific advances in this area. Under FDA labeling regulations, 21 CFR Part 801, a device must have adequate directions for use, which include instructions on preparing a device for use. Instructions on how to reprocess (i.e., clean and disinfect or sterilize) a reusable device are critical to ensuring a reusable device is appropriately prepared for its next use.

Read the full Draft Guidance online here.

Download the full Draft Guidance (PDF) here: Draft Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

From the May 2013 issue of Infection Control Today:

The summit crystallized a compendium of challenges and priority actions for delivering on patients’ basic expectation of cleanliness for reusable medical devices. AAMI emphasizes that the clarion themes that emerged from the summit should serve as a call to action for all stakeholders with roles to play in improving patient safety in reprocessing reusable medical devices. The seven clarion themes are:

  1. Gain consensus on “how clean is clean” and on adequate cleaning validation protocols for reprocessing reusable medical devices.
  2. Create standardized, clear instructions and repeatable steps for reprocessing whenever possible.
  3. Pay early, iterative and comprehensive attention to reprocessing requirements throughout the device design process.
  4. Make human factors and work environment factors priorities when developing reprocessing requirements.
  5. Improve information collection and sharing to broaden the use of best practices in reprocessing.
  6. Improve reprocessing competencies by strengthening training, education and certification.
  7. Create a greater sense of urgency and understanding throughout the healthcare community about the consequences of inadequate reprocessing.

Since the FDA/AAMI summit was held, a number of high-profile outbreaks occurred and the resulting media attention triggered a renewed focus on reprocessing-related issues. It’s no surprise, then, that improper reprocessing of medical devices and surgical instruments is once again on the ECRI Institute’s Top 10 Health Technology Hazards Report for 2013.

Read the full report (PDF): Improper Reprocessing Targeted as One of Healthcare’s Most Dangerous Hazards

From the recently released 2011 AAMI/FDA Reprocessing Summit Report, Executive Summary:

The Medical Device Reprocessing Summit proved to be an opportunity for a renewed emphasis on performing all the necessary steps in reprocessing reusable medical devices to ensure clean and disinfected or sterilized devices—not just in the universe of regulations, standards, and best practices, but also in the harried clinical environments and diverse sterile processing centers that are ground zero for reprocessing.”

Read the full report (PDF): 2011 AAMI/FDA Reprocessing Summit Report

According to a recent Infection Control Today article:

Nelson Laboratories strongly recommends that reusable medical device manufacturers reevaluate their validation testing procedures following a growing trend of increased scrutiny by the Food and Drug Administration (FDA) of the currently accepted validations for cleaning, disinfection and sterilization methods for their devices.

It is clear the FDA is recommending increased testing procedures that more closely simulate the actual and clinical use of reusable medical devices,” says Alpa Patel, department scientist for hospital reprocessing at Nelson Laboratories. “As indicated by recent responses, the FDA would like manufacturers to perform testing on three runs for cleaning validations. This is a change from previous practices and is catching many manufacturers by surprise.”

Read the full article: Nelson Labs Advises Reusable Medical Device Manufacturers to Follow New FDA Guidance

From the April issue of Infection Control Today, an interview with ECRI Institute’s Chris Lavanchy:

Q: What are clinicians and manufacturers’ shared roles when it comes to reducing the potential for device-related problems that can jeopardize patient outcomes?

A: One of the best strategies to overcome some of the device-related problems we’ve been discussing is for hospitals to encourage collaboration between purchasing and central sterile department leadership when discussing the purchase of new instruments from manufacturers. Too often little thought is given to the reprocessing stage of the instrument use cycle when equipment is being acquired. By involving central sterile departments in the process, manufacturers will perhaps more quickly see that ease of reprocessing is an important customer selection factor and give more attention to providing information about reprocessing when marketing their products.

Q: What do you believe to be manufacturers’ responsibility?

A: I think the awareness of device-related reprocessing issues is definitely being raised, and the FDA workshops and the AAMI/FDA summit have been helpful in getting the word out that there are instruments whose cleanability was a secondary consideration in their design. The more that this concern is publicized, the more likely it is that manufacturers will ensure there is very diligent consideration of proper design for cleanability as products are being developed.

Read the full article: Medical Device Reprocessing Challenges: A Q&A with ECRI Institute’s Chris Lavanchy