Below are PDFs containing the independent scientific reports conducted following the hydraulic fluid incident.

PharmaLinkFHI and Duke Quality Assurance Follow-up Program

Summary: This report shares the findings of the independent follow-up registry of potentially exposed patients. As part of Duke’s quality assurance review, PharmaLink conducted a follow-up registry to track the ongoing health of patients through review of their medical records, public sources, and patient reports. The program was designed to detect any unusual pattern of symptoms or illness among the patients. PharmaLink’s analysis provides actual observed rates of certain medical outcomes (such as infection, cancer, or hospitalization), from all causes, collected over the two years following potential patient exposure. These medical outcome rates were then separately compared to expected rates for similar populations. The program did not identify any medical outcome rates that were increased above those expected of a general or similar patient population.

Quality Assurance Follow-up Registry:
Duke and PharmaLink Reports
[ 9.2 MB PDF file]

Report on Instrument Sterilization

Summary: Professor William A. Rutala, PhD, MPH, director of the Statewide Program in Infection Control and Epidemiology at the UNC School of Medicine, investigated whether hydraulic fluid applied to surgical instruments made the sterilization process less effective. Dr. Rutala and his team recreated the situation and concluded the sterilization of the instruments was fully effective.

Rutala Report
[ 129.67 KB PDF file]

RTI Analysis

Summary: This report shares the findings of a second external study done by scientists at RTI International in Research Triangle Park. RTI conducted an analysis to determine how much hydraulic fluid remained on surgical instruments after they had been rinsed in very hot water and then sterilized, as was the case in the incident at Duke Health Raleigh Hospital and Durham Regional Hospital. Their report concluded that the residual amount of fluid on the instruments tested was very small, approximately 0.08 milligrams per instrument, on average. The researchers also tested for the presence of contamination by 11 metals. With the exception of zinc, which is in one of the additives in the original fluid and present at the expected low level, the majority of the metals were not detectable and a few were barely detectable using sophisticated testing equipment.

RTI Report
[ 3.88 MB PDF file]