Goshen Health Hospital and Emergency Room has recently alerted patients undergoing surgical procedures between April 1, 2019 and September 30, 2019 that they may have been exposed to infectious diseases such as the hepatitis B virus, the hepatitis C virus, and the human immunodeficiency virus (HIV) due to their failure to fully complete a multistep sterilization process for certain surgical instruments. According to articles in the Elkhart Truth and The Goshen News, it is possible that around 1200 patients may have been affected by one of Goshen Health’s seven surgical instrument sterilization technicians failing to complete a step in their sterilization process. The situation has gained national attention.
Goshen Health is currently offering free testing to potentially affected patients, and has, according to reports, put additional policies and safety measures in place to make sure that it does not happen again. Depending upon the circumstances surrounding the technician’s error, injuries arising out of a failure to complete a sterilization process step could constitute ordinary and/or professional negligence and could give rise to personal injury and/or medical malpractice claims for physical and emotional injuries by the affected patients.
The Centers for Disease Control and Prevention (CDC) has offered a Guideline for Disinfection and Sterilization in Healthcare Facilities. These guidelines discuss appropriate and recommended sterilization cycle verification (verification of sterilizers with biological and chemical indicators prior to routine use), physical facilities (including areas designed for decontamination, packaging, and sterilization and storage), cleaning (cleaning and decontamination after use to prevent residual debris), packaging (in accordance with guidelines set forth by the Association for the Advancement of Medical Instrumentation (AAMI) and other organizations), loading (allowing for sterilant circulation with proper placement of trays and items), storage (including proper wrapping and handling), and monitoring (routine checking of mechanical, chemical and biological indicators).
Risk of infection should, according to the CDC, be assessed with an infection-control professional, central processing, surgical services, and the risk management staff. Factors to be measured include the chemical indicator result, results of other biological indicators, parameters of the sterilizer, time-temperature charts, and microbial load associated with decontaminated surgical instruments. The CDC Table 12 to the Guideline for Disinfection and Sterilization in Healthcare Facilities for Suggested Protocol for Management of Positive Biological Indicator in a Steam Sterilizer suggests 7 steps:
1. Take Sterilizer Out of Service;
2. Repeat Biological Indicator Test in Three Consecutive Sterilizer Cycles;
3. Check to Ensure Sterilizer was Used Correctly;
4. Check with Hospital Maintenance for Irregularities;
5. Check to Ensure the Correct Biological Indicator was Used and Appropriately Interpreted;
6. If the Above Steps Resolve the Problem, Check if all Three Repeat Biological Indicators from Three Consecutive Sterilizer Cycles are Negative; and
7. If One or Both Biological Indicators are Present, Do One or More of Following Until Resolved: (a) Request an Inspection of the Equipment; (b) Have Hospital Maintenance Inspect the Steam Supply Lines; (c) Discuss Abnormalities with the Manufacturer; and (d) Repeat the Biological Indicator Using a Different Manufacturer’s Indicator.
If the above steps do not work, the CDC recommends that the sterilizer should be closed until the manufacturer can assure that it is operating properly with a retest at that time to be conducted with biological indicators in three consecutive sterilizer cycles.
According to a 2008 study in the Joint Commission Journal on Quality and Patient Safety, physicians only reported 1% of adverse events in their medical practice. Nurses, on the contrary, reported about 45% of adverse events and other hospital employees reported a little more than half of adverse events to attending physicians. As such, even though it goes without saying that a patient should be informed of an adverse event, at least Goshen Health has taken a step in the right direction by alerting its patients of an error in the sterilization process. Hopefully, this error will not cause any patients to acquire a potentially deadly infection. Regardless, on account of the nature of the disease process and medical science, many may not know for months whether they have acquired such an infection, causing them unnecessary emotional distress and worry, which can lead to anxiety, depression, and attendant physical ailments.
Medical malpractice and negligence claims are time-sensitive. Relevant evidence can be lost on account of delay. Goshen patients suffering the worry and distress caused by potentially being infected by unsterile equipment used by healthcare professionals would be wise to explore their legal rights with an experienced medical malpractice lawyer. First and foremost, however, those affected should get the medical care they need by contacting the call center with Goshen Health Colleagues at (574) 364-2100 to schedule blood work.
Barsumian Armiger and its medical malpractice attorneys aggressively represent patients injured by the negligence of hospitals and physicians, including injuries involving infections caused by failures in sterilizing equipment. If you believe you may have been impacted by Goshen Health’s technician’s failure to adhere to the sterilization process and would like to discuss your legal options, contact us today for a no-obligation, free consultation at (844) 268-7775. You can also visit us online, engage in live chat, and/or submit an on-line inquiry to us here.