Indiana hospital patients potentially exposed to infection diseases from sterile processing errors

Nov. 27, 2019

Goshen Hospital in Elkart, IN has alerted 1,182 surgery patients that they may have been exposed to infectious diseases, according to a statement from Goshen Health. The problem was caused by a technician in sterile processing missing an important multistep cleaning process which could result in contaminated surgical equipment.

The hospital issued statement containing the following details:

Recently, the leadership at Goshen Health became aware of a situation that may have impacted a small portion of our surgical patients only at Goshen Hospital from April through September 2019. During this time, one step in a multistep cleaning process was missed for some specific surgical instruments by one of our seven sterilization technicians.    

Our priority is always the well-being of the communities we serve. In this case, we missed the mark and fell below our high standards. This is not acceptable. We are committed to getting it right and ensuring that safety and quality processes are in place so that these mistakes do not occur again.  

When the error was discovered, a cross-functional team of medical professionals was immediately convened to do a root-cause analysis and bring back recommendations. That team took action immediately to correct the problem while identifying processes, policies and safety measures to ensure it does not happen again. This included purchasing additional technology used in only a subset of hospitals across the nation, that further reduces the potential for human error.

As we investigated the details of this event, our team discovered a beginning step in our sterilization process was omitted by a single technician for a small subset of surgical instruments. These instruments were still treated by the rest of our cleaning and sterilization process. This included enzymatic cleaners (chemical), machine washer disinfection and/or ultrasonic cleaner process, and also high steam temperatures and pressure for a long period of time. These sterilization processes provide a wide margin of safety and significantly reduce risks for patients. At the same time, since one step in the process did not occur, we needed to make sure that no problems resulted and no patients were harmed. 

While our sterile processing and infectious disease experts believe that the potential transmission of blood borne viruses between patients is extremely remote, out of an abundance of caution, we want to verify through lab blood tests that patients have not been harmed. We elected to cast a wide net to inform via letter all patients that may have been affected while offering free testing to ensure everyone’s safety.   

If a Goshen Health patient did not receive a letter, it means they were not impacted. This issue was isolated to a small subset of our patients that we have notified directly, and other surgical patients during this time frame are not at risk. If you are concerned you should have received a letter, please call our call center at (574) 364-2100. For those patients that are involved, we have taken steps to set up a Goshen Health call center to answer questions and schedule testing. We want to be responsive to questions and concerns, and there are no costs for these screenings.

As Chief Executive Officer and Chief Medical Officer, we want to apologize for what occurred and the worry and anxiety this situation has caused. While the testing and communication goes beyond what may be needed, we want to take every precaution to ensure the safety and well-being of our community.  

Goshen Health has the statement