Instrument Biofilm

Biofilm Was Probable Cause Of Contaminated Instruments At Hospital Last month we examined the initial news report on a hospital that had a large outbreak of contaminated surgical instruments (Novo blog 41, May 17, 2018). This tragic event has caused a lot of significant, painful and costly consequences to the hospital and their patients. The initial report disclosed that “Surgical staff discovered a ‘brown-yellowish, what looked like a pasty material’ on the instruments.” Additionally, on April 4, 2018, the Colorado Department of Public Health and Environment (CDPHE) announced a disease control investigation the hospital.¹ “CDPHE said instruments used in some surgeries were not cleaned adequately. The hospital said it identified a gap in the pre-cleaning process, prior to sterilization. The hospital sent letters to thousands of orthopedic and spinal surgery patients, who had procedures between July 21, 2016, and February 20, 2018. Those letters said patients could be at risk for hepatitis or HIV and should get a blood test.”² According to a new report, “Biofilm appears to be behind the infection breakout that last month forced the Denver hospital to suspend all surgeries for nearly a week. We don't know for certain what caused post-op infections in several patients who had orthopedic or spine surgery performed at the hospital over the last couple of years, but a trail of evidence points to improper instrument cleaning practices and the hidden menace known as biofilm.”³ This new report points out that:

• When surgical site infections are linked back to surgical instruments, biofilm is likely a root cause.
• The infection outbreak spanned nearly 2 years, from July 21, 2016, to April 5, 2018. Whatever was causing the infections were recurrent and undetectable, telltale characteristics of biofilm.
• The hospital sent precautionary letters to about 5,300 patients who underwent orthopedic or spinal surgery at the hospital during that time. The letter explains that the sterilization issue revolved around the first step in a multistep process: a pre-cleaning process that occurs before instruments go through "intense heat sterilization."
• Health officials determined that the infection control breach was due to human error that occurred during "a gap" in the manual pre-cleaning phase — before the instruments underwent heat sterilization. Staff at Porter Adventist wiped down, soaked and scrubbed certain spine and orthopedic instruments, but apparently not well enough. The instruments likely still contained bioburden when they were sent along for automated cleaning and heat sterilization.
• Since warning patients of the pre-cleaning breach, the hospital discovered residue on instruments after sterilization. The hospital first suspected this was due to a water quality issue, but tests showed the water quality was well within the typical range found in drinking water. It turns out that a mineral buildup in a cleaning machine caused the residue.⁴

Medical device reprocessing personnel have always been told that “If it’s not clean, it can’t be sterile.” As frequent readers of this blog know, the more accurate statement is that “If it’s not clean, it can’t be safe!” The recent events at this hospital sadly demonstrate that just because you sterilize a device does not mean that it is safe to use, especially if it is still contaminated with residual bioburden or biofilm prior to sterilization. A frequent cause of a surgical infection is dead, sterile organic material (i.e., biofilm) that gets deposited into the body from a ‘sterile’ instrument that was not completely clean prior to sterilization.⁵ The problem of contaminated instruments in the O.R. was first addressed by the CDC in their September 11, 2015 Health Alert Advisory that stated: “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.”⁶ Protecting your patients from harm caused by a contaminated instrument starts by following manufacturers’ published cleaning and reprocessing IFUs. Even more important than following the manufacturers’ published IFUs is to demand IFUs that have been validated by independent laboratory testing using AAMI and FDA test protocols. By using instruments with validated IFUs you and your staff can have the documented assurance of providing clean, sterile, moisture-free instruments for every patient, every time! 1. NBC News 9, Denver, Colorado. 2. Op. Cite. 3. Outpatient Surgery, June 5, 2018 4. Op. Cite. 5. “Guideline For The Prevention Of Surgical Site Infection” Center For Disease Control and  Prevention 6. Centers for Disease Control and Prevention Health Alert Advisory HAN00323, September 11, 2015.