ECRI Institute’s “Top Ten Technology Hazards for 2017”

The ECRI Institute has just published their “Top Ten Technology Hazards for 2017” (attached). The number 2 problem on the list is entitled “Inadequate Cleaning Of Complex Reusable Instruments Can Lead To Infection.” In identifying the severity of the problem of dirty instruments, the report states “Such contamination can lead to disabling or deadly patient infections.” It goes on to state that “Incidents can also expose healthcare facilities to liability that can jeopardize their reputation.”

The report points out that “Of particular concern are complex, reusable instruments whose design makes the instruments difficult to clean.” The complex design of Laparoscopic instruments and Kerrison Rongeurs make them especially difficult, if not impossible, to thoroughly decontaminate and clean.

In order to help solve this major patient hazard, the ECRI Institute recommends that healthcare facilities consider “purchasing only instruments for which the manufacturer has validated its cleaning instructions. When applicable, request written information explaining the validation process.” The ECRI Institute report also emphasizes that “FDA has become increasingly aware of the inconsistent quality of cleaning and reprocessing instructions.” The FDA now requires manufacturers of reusable instruments to validate their cleaning instructions.

Your healthcare facility should be demanding validated cleaning IFUs from ALL of your instrument suppliers, including suppliers of instruments that have to be disassembled during reprocessing. Failure to demand validated cleaning IFUs from your instrument manufacturers is a tremendous patient safety issue. Healthcare facilities have a legal, ethical, financial and moral obligation to only use instruments whose IFUs have been validated using FDA validation protocols.

The unique, patented AIM Clear Flush instruments have been validated* using FDA testing protocols to ensure clean, sterile, moisture-free instruments for every patient, every time!

*Nelson Laboratories and Midbrook Biomedical Cleaning Validation Reports

To learn more about ECRI Institute, go to their website

“Hospital Personnel Must Demand Validated IFUs” – HPN May 2016

The May issue of Healthcare Purchasing News (HPN) has a very powerful piece on the need for validated cleaning IFUs for all of your surgical instruments ( The article is especially important for you and your staff as you constantly strive to ensure clean, sterile, moisture-free instruments for every patient, every time.  According to HPN:

  • To ensure device cleaning, disinfection and sterilization effectiveness, SPD staffers 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 Food and Drug Administration (FDA) stipulates in its guidelines that device manufacturers validate the design, functionality and end-user operation of the devices they make, including reprocessing instructions (IFUs).

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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.”

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FDA issues warning to medical device makers over failure to validate cleaning IFU

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.

A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care

James, John T. PhD

Journal of Patient Safety
September 2013 – Volume 9 – Issue 3 – p 122-128


Objectives: Based on 1984 data developed from reviews of medical records of patients treated in New York hospitals, the Institute of Medicine estimated that up to 98,000 Americans die each year from medical errors. The basis of this estimate is nearly 3 decades old; herein, an updated estimate is developed from modern studies published from 2008 to 2011.

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Lawsuit Charges Pentax Negligence Led to Fatal Superbug Infection

September 1, 2015

Lexi J. Hazam of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that the adult children of Renate Winkler as administrators of her estate have filed a wrongful death lawsuit against Pentax Medical, a division of Pentax of America, Inc., and Advocate Lutheran General Hospital, which is located in the Chicago suburb of Park Ridge, Illinois. Ms. Winkler died on December 7, 2013 from carbapenem-resistant Enterobacteriaceae or CRE, a bacteria that is highly resistant to antibiotics, following Endoscopic Retrograde Cholangiopancreatography or ERCP at Advocate Lutheran General Hospital. For the procedure, the hospital used a duodenoscope manufactured and sold by Pentax Medical.

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Finally, ‘Validated Clean’ Kerrison Rongeurs For Every Patient, Every Time

Surgeons, O.R. nurses, reprocessing personnel, and instrument manufacturers have long known that conventional Kerrison Rongeurs are the dirtiest, most difficult instrument to decontaminate and clean in a neuro-surgical case. Now, with the introduction of the world’s only ‘flushable’ Kerrison Rongeur, and the use of the innovative Tempest Washer, there is no need to disassemble, manually clean, and reassemble the Kerrison for effective reprocessing.

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AIM Clear Flush® Kerrison Cleaning Validation Test

Clear Flush Kerrison with Connector

Clear Flush® Kerrisons….your “Connection” to Clean, Sterile, Moisture-Free Kerrisons for Every Patient, Every Time!

In a laboratory test described as a ‘worst case’ scenario, six AIM Clear Flush® Kerrisons (1mm – 6mm) were inoculated with Artificial Test Soil (ATS) containing hemoglobin, protein, and carbohydrate and allowed to dry for twenty-four (24) hours. The Kerrisons were then placed into a Tempest Washer and 100% of the dried, encrusted test soil was flushed from all six of the world’s only flushable, patented Clear Flush® Kerrisons.

Continue reading Are hospitals using dirty surgical tools?

A new report suggests doctors across the country are using surgical tools contaminated with blood and other debris and because the FDA doesn’t require hospitals to report it, many incidents are unknown. NBC’s chief medical editor Dr. Nancy Snyderman reports.

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Source: NBC Today Show, Feb. 22, 2012