Covid-19 and the Need for Validated IFUs

COVID-19 represents the single largest pandemic to hit the world in the past 100 years. By the end of October, 2020, the pandemic will have taken the lives of over 230,000 Americans since its outbreak in January. (1) Clearly, any and all steps that can be taken to reduce this deadly virus need to be taken. Given that COVID-19 is a virus, what possible role could validated reusable medical device IFU’s play in the fight against this deadly disease? To answer that question, we first need to have a better understanding of the underlying causes that contribute to COVID-19 deaths. According to data from the Centers for Disease Control and Prevention (CDC), the virus is the sole cause of death in only six percent (6%) of all reported COVID-19 deaths.(2)  In the other ninety four percent (94%) of reported deaths, there were one or more comorbidities present at the time of death. If you go to the National Center for Health Statistics you can see “…the types of health conditions and contributing causes mentioned in conjunction with deaths involving coronavirus disease 2019 (COVID-19). For 6% of the deaths, COVID-19 was the only cause mentioned. For deaths with conditions or causes in addition to COVID-19, on average, there were 2.6 additional conditions or causes per death. The number of deaths with each condition or cause is shown for all deaths and by age groups.”3 In looking at the causes of COVID-19 deaths, this data provides very revealing, important information. What the data is telling us is that in 94% of all COVID-19 deaths, there was an additional 2.6 comorbidity conditions present in the patient at the time of death. These comorbidity conditions include respiratory diseases, circulatory diseases, diabetes, vascular diseases, hospital acquired infections and sepsis. The Centers for Disease Control and Prevention (CDC) documents the fact that hospital acquired infections (HAIs) are one of the leading causes of morbidity and mortality among hospital patients in the United States. (4) According to HealthyPeople 2020, HAIs are a leading cause of preventable deaths in the U.S. (5) The fight against HAIs needs to be a major focus for all healthcare personnel in every hospital, surgi-center and healthcare facility. Surgical site infections (SSIs) are one of the leading causes of HAIs and account a significant percentage of HAIs. Therefore, any and all steps taken to reduce the risk of an SSI should be taken to reduce patient risk should they contract COVID-19 while suffering with and SSI. A major source of SSIs is contaminated reusable devices and surgical instruments that are still contaminated after reprocessing and are then returned to surgery. What steps can and should your facility take to reduce your patients’ risk of contracting an SSI from a contaminated instrument? The first step begins with the purchasing process and decision making for reusable devices and instruments. When considering the acquisition of new instruments, the AAMI “Checklist” states that: “Preventing reusable medical device–related HAIs begins with the active and committed participation in the purchasing process to identify the resources that each stakeholder must have in order to prevent contamination.”6 The ECRI Institute in their "Top Ten Technology Hazards for 2017" report states that the number two patient hazard is: "Inadequate Cleaning of Complex Reusable Instruments Can Lead to Infection."7   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. They also recommend that “When applicable, request written information explaining the validation process."8 The first step in reducing your patients’ risk of contracting an SSI begins when purchasing new surgical instrumentation. To reduce that risk, your healthcare facility should be demanding validated cleaning IFUs from ALL of your instrument suppliers, including take-apart suppliers. According to the ECRI Institute report, 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 and AAMI validation testing protocols. Fighting the deadly COVID-19 pandemic is the single most important challenge every healthcare worker faces. An important step that you and your facility can take in reducing a patient’s risk of contracting an HAI is to demand validated IFUs. 1 https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm#Comorbidities 2 Ibid “CDC” 3 Ibid “Table 3 Comorbidities” 4 https://www.cdc.gov/ 5 https://www.healthypeople.gov/2020/ 6 Ibid “AAMI” 7 https://www.ecri.org/Pages/2017-Hazards.aspx 8 Ibid “ECRI”