Background: Since 2009, the CDC has invested in nationwide outbreak response capacity through Healthcare-associated Infections and Antimicrobial Resistance (HAI/AR) Programs in public health departments. The unpredictable nature of outbreaks requires public health programs to be able to scale operations and adapt strategies to effectively respond to emerging challenges, as demonstrated by the COVID-19 pandemic. This analysis characterizes HAI/AR Programs response capacity in scalability, adaptability, and technical expertise. Method: We reviewed data from HAI/AR Programs in 50 state, 6 local, and 2 territorial health departments (August 2019–December 2022). HAI/AR responses were defined as specific public health actions to assess an acute risk and prevent further harm in the context of a confirmed or possible healthcare outbreak; responses were categorized as involving novel or targeted multi-drug resistant organisms (nMDROs), COVID-19, and HAIs or infection control breaches. Descriptive statistics were used to analyze reported responses in three domains: scalability (number of responses per year), adaptability (number of pathogens and healthcare facility types involved in responses), and technical expertise (number of responses involving onsite or remote infection control assessments). The annual number of responses conducted in 2019 was estimated based on five months of data (Aug–Dec); all other results were calculated directly. Results: From August 2019 to December 2022, 58 HAI/AR Programs reported 141,445 responses (87% COVID-19, 11% nMDROs, 2% other HAIs or infection control breaches). Annually, programs conducted an estimated 5,546 responses in 2019, and this figure rose to 42,359 in 2020, 49,124 in 2021, and 47,651 in 2022. Outbreak responses involved 110 different pathogens, including emerging infectious diseases (e.g., SARS-CoV-2, mpox), nMDRO (e.g., carbapenemase-producing organisms, Candida auris), and other pathogens (e.g., hepatitis viruses, Mycobacterium abscessus) across >20 setting types (e.g., acute care hospitals, skilled nursing facilities, ambulatory surgery centers, assisted living facilities). Additionally, programs responded to infection control breaches in the absence of identified patient infections, including drug diversion, medical device reprocessing, and injection safety breaches. Programs conducted 50,245 infection control assessments during reported responses. Conclusion: From 2019–2022, as the COVID-19 pandemic took hold, HAI/AR Programs effectively utilized CDC funding to scale their response operations with an 8-fold increase in annual response activity, including a 24% increase for non-COVID-19 responses. Programs adapted responses to various pathogens, including emerging infectious diseases, across various setting types. Health department staff utilized technical expertise to conduct infection control assessments. This analysis provides valuable insights into the resilience and impact of HAI/AR Programs nationwide.

Background: Nonsterile ice is frequently used in healthcare settings for a wide array of patient care activities and clinical procedures. However, this ice can harbor pathogenic organisms which can threaten patient safety and cause outbreaks. We sought to characterize recent Centers for Disease Control and Prevention (CDC) consultations involving ice leading to healthcare-associated infections (HAIs). Methods: We reviewed internal CDC records from the Division of Healthcare Quality Promotion (DHQP) to identify investigations of outbreaks and potential outbreaks involving the use of ice in healthcare facilities. We searched records from January 1, 2016, through November 30, 2023, for keywords related to ice. We excluded consultations in which ice was not thought to be a potential transmission pathway as well as those in which only sterile ice products (e.g., saline slush) were investigated. Results: We identified 45 consultations for ice-related investigations, involving a total of 533 patients. Nontuberculous mycobacteria were the most frequently implicated organisms, appearing in 40% (n=18) of investigations. Eighty-four percent (n=38) of investigations occurred in acute care hospitals. The most frequently implicated hospital settings were intensive care units (13%, n=6), operating rooms (13%, n=6), and bronchoscopy suites (13%, n=6). We identified a variety of plausible exposure pathways, including direct ingestion of ice by patients, use of ice during the bronchoscopy procedure, use of nonsterile ice in heater-cooler devices during cardiothoracic surgery, and the use of ice to chill saline for respiratory care. Environmental sampling directly of ice machines was performed in 62% of investigations (n=28) and nonsterile ice from these machines was sampled in 9% of investigations (n=4). Among those investigations in which ice machines were sampled, the organism implicated in the outbreak was isolated in 54% of investigations (n=15). Among those investigations in which ice itself was sampled, the organism implicated in the outbreak was isolated in 75% of investigations (n=3). These organisms included Mycobacterium mucogenicum, Burkholderia multivorans, and Acanthamoeba spp. Conclusions: The use of nonsterile ice during clinical care is a potential source of pathogens that cause patient infections and HAI outbreaks. Healthcare personnel should be aware of the risk posed by nonsterile ice and consider avoiding its use, especially when caring for patients who are critically ill or immunocompromised. Healthcare facilities should ensure regular cleaning and disinfection of ice machines to decrease their microbial burden. When HAI outbreaks involving water-associated organisms are identified, nonsterile ice should be considered as a potential mode of transmission.

Background: Stenotrophomonas maltophilia is an opportunistic pathogen found in healthcare settings. During April–September 2022, nine S. maltophilia bloodstream infections (BSIs) were identified among intensive care unit (ICU) patients at a hospital in Alameda County, California. Whole genome sequencing found isolates to be highly related. Despite implementation of infection prevention and control (IPC) interventions, four additional S. maltophilia BSIs were identified during June–September 2023. We investigated to identify risk factors for infection and stop transmission. Methods: We conducted a matched case-control study. A case was defined as S. maltophilia isolated from a blood culture from an ICU patient with a fever during April 2022–September 2023; control-patient subjects were patients admitted to the ICU during the same period with hospital stay greater than or equal to their matched case. Three control subjects were matched to each case. We extracted information on risk factors for infection from medical charts and observed IPC practices in hospital locations of interest. We collected environmental samples from the ICU, radiology unit, and emergency department. Results: Among 13 cases and 39 control subjects, patients exposed to iodinated contrast Omnipaque-300 (odds ratio [OR]: 5.7; 95% CI: 1.2–28.0), injectable propofol (OR: 12.2; 95% CI: 1.5–101.4), or fentanyl (OR: 9.2; 95% CI: 1.8–Inf.) were more likely to have a S. maltophilia BSI, compared with control-subjects. IPC deficiencies included improper cleaning and storage of medical equipment, including the contrast injection system, and patient care supplies. The outbreak strain of S. maltophilia was not isolated from environmental samples. Conclusions: Although a point-source was not identified, S. maltophilia was likely transmitted through improper IPC practices involving injectable contrast or anesthesia. Recommendations on proper cleaning and disinfection of the contrast injection system and proper storage, preparation, and administration of medications were made to reduce risk for contamination.

Consultations with the Centers for Disease Control and Prevention’s Division of Healthcare Quality Promotion revealed patient harms associated with ophthalmic care. Adherence to core infection prevention and control principles, tailored guidance for ophthalmic settings, and compliance with manufacturing and compounding standards could decrease adverse events and patient exposures to contaminated products.

In this summary of US Centers for Disease Control and Prevention (CDC) consultations with state and local health departments concerning their bronchoscope-associated investigations from 2014 through 2022, bronchoscope reprocessing gaps and exposure to nonsterile water sources appeared to be the major routes of transmission of infectious pathogens, which were primarily water-associated bacteria.

Background: Stenotrophomonas maltophilia is an important cause of opportunistic healthcare-associated infections (HAIs) in critically ill patients and is difficult to treat due to intrinsic resistance to multiple antibiotic classes. During the COVID-19 pandemic, the CDC received anecdotal reports of increases in S. maltophilia respiratory infections. To further investigate these reports, we used a national electronic healthcare database to evaluate changes in S. maltophilia during the pandemic. Methods: Using the PINC-AI healthcare data (Premier Inc, Charlotte, NC) we identified all potential HAIs by calculating the total number of unique patients hospitalized during January 1, 2018, through December 31, 2021, who had any organism isolated on clinical culture obtained >3 days after admission. We calculated the proportion of patients with S. maltophilia detected in culture and stratified them by specimen source. To determine whether COVID-19 diagnosis influenced the proportion of patients diagnosed with S. maltophilia respiratory infections during the pandemic (January 1, 2020–December 31, 2021), we calculated the proportion of patients with S. maltophilia detected among those with any bacterial pathogen isolated from a respiratory culture >3 days after hospitalization. We stratified these results by presence or absence of concurrent COVID-19 diagnosis. Pearson χ2 test was used to test for differences where appropriate. Results: Among hospitalized patients with any organism isolated from a clinical culture, the proportion with S. maltophilia detected was higher in 2021 (n = 2,554 of 118,029, 2.2%) than in 2018 (n = 2,063 of 155,624, 1.3%) p 3 days after hospital admission from 2018 to 2021. Most patient isolates were from respiratory specimens. A concurrent diagnosis of COVID-19 did not appear to increase the likelihood of respiratory S. maltophilia detection. The increases in S. maltophilia during the pandemic might be explained by challenges inherent to caring for increased numbers of higher-acuity patients during this time, including staffing shortages and changes to infection prevention practices. Additional exploration of these data, as well as data from other sources and from additional years, may help to elucidate this issue more fully.

Disclosures: None

Background: Healthcare activities that include instrumentation or manipulation of mucosal tissue or normally sterile sites, such as the eye and its associated structures, place patients at risk of infectious and other complications. We reviewed queries to the CDC Prevention and Response Branch that were focused on ophthalmologic procedures and settings to examine opportunities to improve infection prevention and control (IPC) practices in these settings. Methods: We reviewed internal CDC consultation records received from January 1, 2016, through December 31, 2021, to identify those involving ophthalmologic procedures or settings. Consultations were reviewed to determine setting type, number of patients affected, organisms identified, nature of infection control breaches, and whether medical products were implicated. Descriptive statistics were calculated. Results: We identified 24 consultations among 19 states and US territories. Of these, 21 (87.5%) involved outpatient settings, of which 9 (43%) were ambulatory surgery centers. Consultations included the following non–mutually exclusive categories. There were 18 adverse postsurgical events (75%), such as mycobacterial infection after laser surgery and toxic anterior segment syndrome following cataract surgery (n = 5). There were 11 infections following ophthalmologic clinical care (46%), such as epidemic keratoconjunctivitis due to adenovirus 8. There were 8 suspected medication-related events (33%) including contamination of ophthalmic medication when manufactured or compounded offsite. There were 8 medical-device reprocessing concerns (33%) including inappropriate high-level disinfection. There were 8 instances of improper environmental cleaning and disinfection (33%), for example, during an adenovirus outbreak. There were 3 cases of potential mishandling of medications onsite (12.5%), such as multiuse eye drops. Also, 3 events (12.5%) were associated with potentially contaminated donor tissue, such as corneas for transplantation. When a consultation included identification of a pathogen (n = 11), organisms included bacteria (n = 7, 64%), viruses (n = 2, 18%), and fungi (n = 3, 27%). In total, 202 patients had confirmed ophthalmologic infections or adverse events. Conclusions: Based on our review of recent outbreaks, healthcare personnel in ophthalmologic settings may have deficits in training related to instrument reprocessing and environmental cleaning specific to ophthalmic equipment and settings that can result in harm to patients. These settings could benefit from targeted training to improve IPC practices specific to ophthalmologic examinations and procedures. This review was limited to analysis of investigations that were voluntarily reported to the CDC. A formal surveillance system for adverse outcomes in this setting could clarify the nature and frequency of IPC issues of greatest concern.

Disclosures: None

Background: Burkholderia multivorans are gram-negative bacteria typically found in water and soil. B. multivorans outbreaks among patients without cystic fibrosis have been associated with exposure to contaminated medical devices or nonsterile aqueous products. Acquisition can also occur from exposure to environmental reservoirs like sinks or other hospital water sources. We describe an outbreak of B. multivorans among hospitalized patients without cystic fibrosis at 2 hospitals within the same healthcare system in California (hospitals A and B) between August 2021 and July 2022. Methods: We defined confirmed case patients as patients without cystic fibrosis hospitalized at hospital A or hospital B between January 2020 to July 2022 with B. multivorans isolated from any body site matching the outbreak strain. We reviewed medical records to describe case patients and to identify common exposures. We evaluated infection control practices and interviewed staff to detect exposures to nonsterile water. Select samples from water, ice, drains, and sink splash zone surfaces were collected and cultured for B. multivorans in March 2022 and July 2022 from both hospitals. Common aqueous products used among case patients were tested for B. multivorans. Genetic relatedness between clinical and environmental samples was determined using random amplified polymorphic DNA (RAPD) and repetitive extragenic palindromic polymerase chain reaction (Rep-PCR). Results: We identified 23 confirmed case patients; 20 (87%) of these were identified at an intensive care unit (ICU) in hospital A. B. multivorans was isolated from respiratory sources in 18 cases (78%). We observed medication preparation items, gloves, and patient care items stored within sink splash zones in ICU medication preparation rooms and patient rooms. Nonsterile water and ice were used for bed baths, swallow evaluations, and ice packs. B. multivorans was cultured from ice and water dispensed from an 11-year-old ice machine in the ICU at hospital A in March 2022 but no other water sources. Additional testing in July 2022 yielded B. multivorans from ice and a drain pan from a new ice machine in the same ICU location at hospital A. All products were negative. Clinical and environmental isolates were the same strain by RAPD and Rep-PCR. Conclusions: The use of nonsterile water and ice from a contaminated ice machine contributed to this outbreak. Water-related fixtures can serve as reservoirs for Burkholderia, posing infection risk to hospitalized and immunocompromised patients. During outbreaks of water-related organisms, such as B. multivorans , nonsterile water and ice use should be investigated as potential sources of transmission and other options should be considered, especially for critically ill patients.

Disclosures: None

The intent of this document is to highlight practical recommendations in a concise format designed to assist acute-care hospitals in implementing and prioritizing their surgical-site infection (SSI) prevention efforts. This document updates the Strategies to Prevent Surgical Site Infections in Acute Care Hospitals published in 2014.1 This expert guidance document is sponsored by the Society for Healthcare Epidemiology of America (SHEA). It is the product of a collaborative effort led by SHEA, the Infectious Diseases Society of America (IDSA), the Association for Professionals in Infection Control and Epidemiology (APIC), the American Hospital Association (AHA), and The Joint Commission, with major contributions from representatives of a number of organizations and societies with content expertise.

One in six nursing home residents and staff with positive SARS-CoV-2 tests ≥90 days after initial infection had specimen cycle thresholds (Ct) <30. Individuals with specimen Ct<30 were more likely to report symptoms but were not different from individuals with high Ct value specimens by other clinical and testing data.

We describe a large outbreak of severe acute respiratory coronavirus virus 2 (SARS-CoV-2) involving an acute-care hospital emergency department during December 2020 and January 2021, in which 27 healthcare personnel worked while infectious, resulting in multiple opportunities for SARS-CoV-2 transmission to patients and other healthcare personnel. We provide recommendations for improving infection prevention and control.

Background: Rapid response is critical to control healthcare-associated infection (HAI) and antibiotic resistance threats within healthcare facilities to prevent illness among patients, residents, and healthcare personnel. Through this analysis, we aimed to quantify public health response activities, by healthcare setting type, for (1) novel and targeted multidrug-resistant organisms or mechanisms (MDROs), (2) SARS-CoV-2, and (3) other possible outbreaks. Method: We reviewed response activity data submitted by US state, territorial, and local health department HAI/AR programs to the CDC as part of funding requirements. We performed descriptive analyses of response activities conducted during the funding reporting period (August 2019–July 2020). SARS-CoV-2 response activities were reported from January through July 2020. Data were analyzed by response category (novel or targeted MDRO, SARS-CoV-2, other HAI/AR responses), and healthcare setting type. Results: During August 2019–July 2020, 57 HAI/AR Programs (50 state, 1 territorial, 5 local health departments, and District of Columbia) reported 18,306 public health responses involving healthcare facilities. These data included 3,860 responses to 1 or more cases of novel or targeted MDROs, 13,992 responses to SARS-CoV-2 outbreaks (beginning in January 2020), and 454 responses to other possible outbreaks. Novel and targeted MDRO responses most frequently occurred in acute-care hospitals (ACHs, 64.5%), skilled nursing facilities (SNFs, 24.5%), and long-term acute-care hospitals (LTACHs, 5.8%). SARS-CoV-2 responses most frequently occurred in SNFs (55%), and assisted living facilities (24%). Other HAI/AR responses most frequently occurred in ACH (50%), SNF (28.4%), and outpatient settings (19.6%). Of the “other” HAI/AR responses, 76% were responses to cases, clusters, or outbreaks, and 23.8% were responses to serious infection control breaches including device and instrument reprocessing, injection safety, and other deficient practices. Conclusions: During the study period, public health programs performed a high volume of HAI/AR response activities largely focused on SARS-CoV-2 in nursing homes and assisted living facilities. Other important response activities occurred across a range of other healthcare settings, including responses to novel and targeted MDROs, HAI outbreaks, and serious infection control breaches. Whereas SARS-CoV-2 response activities largely centered in long-term care settings, MDRO and other HAI/AR responses occurred mostly in acute-care settings. These data demonstrate the importance of building and sustaining public health response capacity for a broad array of healthcare settings, pathogens, and patient populations to meet the range of current and emerging HAI/AR threats.

Funding: None

Disclosures: None

Background: Throughout the COVID-19 pandemic, CDC Division of Healthcare Quality Promotion (DHQP) has provided technical assistance in support of state, tribal, local, and territorial health departments for COVID-19 healthcare outbreak management and infection prevention and control (IPC). We characterized the volume and trends of technical assistance provided during the pandemic to inform the future needs of health departments for COVID-19 healthcare IPC and DHQP resources required to meet these needs. Methods: In January 2020, DHQP began receiving COVID-19 IPC TA requests directly from health departments for remote assistance or from CDC staff on field deployments providing onsite support. DHQP subject-matter experts provided responses via e-mail or, for more complex inquiries, outbreaks, or field deployments, via phone consultations. Records of e-mail communications and phone consultations were entered into an inquiry database for tracking. We calculated the number, mean, and range of technical-assistance responses by jurisdiction and by month from January 2020 through December 2021. We designated months as high-volume periods for technical assistance if inquiries surpassed the 75th percentile. Results: In total, 1,869 IPC technical-assistance responses were provided. Of all technical-assistance responses, 1,725 (92%) were to state or local health departments, 115 (6%) were tribal nations, and 28 (2%) were US territories. IPC technical assistance was provided to all 50 states and the District of Columbia, 16 tribal nations, and 5 US territories. The average total number of technical assistance responses per site during the 24-month period was 34 to state and local HDs (range, 2–111), 6 to tribal nations (when tribal nation was specified; range, 1–17), and 6 to US territories (range, 1–15). E-mail communications comprised 1,164 responses (62%); phone consultations made up the remaining 705 responses (38%). Of phone consultations, 350 (50%) were with CDC field deployers providing onsite support to health departments. The average number of technical-assistance responses provided each month across all jurisdictions was 78 (range, 0–334); months with high volumes included April–August 2020 and January 2021. Conclusions: These findings highlight the high-level collaboration between federal and state, tribal, local, and territorial health department partners in remote and onsite support of COVID-19 prevention and response efforts in healthcare settings. Variations in monthly volumes of health-department COVID-19 healthcare IPC technical assistance requests may reflect factors such as fluctuations in community infection rates and changes in CDC IPC guidance. The ability to provide effective technical assistance during pandemic response depends on the CDC maintaining sufficient healthcare IPC staffing and expertise.

Funding: None

Disclosures: None

Background: Documented transmission of infectious agents involving dental care is uncommon. However, increasing attention to dental infection control, along with several recent outbreaks, have identified infection control gaps in dental settings. We describe CDC consultations involving outbreaks or infection control lapses occurring in dental settings to identify areas for prevention efforts. Methods: We reviewed internal CDC records from January 1, 2010, through October 1, 2019, to identify consultations involving investigations of potential or confirmed disease transmission and infection control lapses in dental settings. We determined yearly number of consultations, number of patients infected, how disease transmission or infection control breaches were identified, suspected mode of transmission, type of infection control breaches identified, and whether at-risk patients were notified. Results: We identified 41 consultations, among 27 states, involving investigation of possible disease transmission or infection control lapses in dental facilities. The number of consultations increased from 11 to 30 between the first half (2010–2014) and the second half (2015–2019) of the period and involved at least 113 infections confirmed or suspected to be associated with dental procedures. Most investigations (n = 29, 71%) began with identification of infection control breaches absent known patient infections; 8 (20%) investigations were initiated after identification of a single patient infection raised concerns for possible transmission associated with dental care (eg, single case of acute hepatitis B infection absent other risk factors). Moreover, 4 investigations involved >1 patient infection; 3 were outbreaks confirmed to be due to poor infection control practices. The most common infection control breaches were lapses in dental instrument reprocessing (n = 28, 78%), for example, failure to sterilize dental handpieces or failure to use biologic indicators. Of the 23 consultations where patient notification activities were discussed, 17 (74%) resulted in notification; >20,000 patients received information about their potential exposure, usually accompanied by advice on seeking screening tests. Conclusions: Dental-related consultations have increased in recent years, and they highlight the need for improved infection control training of dental healthcare personnel, especially related to dental instrument reprocessing. The CDC Division of Oral Health and the Organization for Safety, Asepsis, and Prevention offers tools, training, and other resources to help dental facilities improve infection control practices. Not all investigations resulted in notifying at-risk patients, but notification should be strongly considered, especially when serious breaches are identified, to promote transparency and help identify disease transmission that could otherwise go undetected.

Funding: None

Disclosures: None

Background: Exposure to medical devices can be a risk factor for the development of healthcare-associated infections; bronchoscopes are a leading cause of device-associated outbreaks. We describe bronchoscope-related outbreaks and pseudo-outbreaks reported to the Centers for Disease Control and Prevention’s Division of Healthcare Quality Promotion (DHQP), and we summarize investigation steps and control measures. Methods: We identified bronchoscope-related consultations with state and local health departments between July 1, 2014, and September 30, 2019, in the DHQP database. We abstracted data on patient symptoms, clinical culture results, investigation findings, and subsequent infection prevention and control interventions. Results: We identified 15 consultations involving 150 patients (range, 3–31 patients per consultation). Each consultation involved at least 1 cluster of the same organism. Organisms associated with bronchoscope-associated clusters were nontuberculous mycobacteria (n = 7), Candida spp (n = 3), Exophiala spp (n = 2), Pseudomonas aeruginosa (n = 2), Enterobacter spp (n = 2), and Raoultella planticola, Stenotrophomonas maltophilia, Achromobacter spp, Mycobacterium tuberculosis, and Aspergillus spp (1 each; 2 consultations involved multiple pathogens). Procedures from which these patient specimens were collected included bronchoalveolar lavage, bronchial wash, bronchial brushing, sputum swab, and lymph node biopsy. For the 7 outbreaks in which clinical data were available, 5 did not have patients with clinical infections related to the pathogen recovered. Two consultations involved pseudo-outbreaks: one involved contamination of specimen collection tubes and the other involved contamination of cultures within the laboratory. Potential underlying pathogen sources included contaminated bronchoscopes (inadequate reprocessing or device damage) (n = 10, 67%), use of nonsterile ice, water, or saline during the procedure (n = 4, 27%), contaminated specimen collection tubes (n = 1, 7%), contaminated bronchoscope suite (n = 1, 7%), and clinical laboratory contamination (n = 1, 7%). The most common interventions included improvement of reprocessing procedures (n = 5), removal of possibly damaged bronchoscopes (n = 4), and eliminating nonsterile ice and water exposures in bronchoscopy (n = 3). Conclusions: Water-related organisms were the most commonly identified pathogens in bronchoscope-related consultations, highlighting the important role that exposure to contaminated water during bronchoscopy and bronchoscope reprocessing might play in bronchoscopy-associated outbreaks and pseudo-outbreaks. During bronchoscope-related outbreaks identifying a common pathogen could indicate problems in bronchoscope handling or reprocessing, device damage, or exposure to nonsterile water.

Funding: None

Disclosures: None

Background: Contaminated pharmaceutical products pose serious infection risks to patients and can lead to significant morbidity and mortality. Contamination at the point of manufacturing or compounding (intrinsic contamination) has the potential to affect large numbers of patients. Public health plays a critical role in detecting and investigating such events. We identified investigations involving intrinsically contaminated pharmaceuticals to characterize the burden and scope of harm associated with these events. Methods: We reviewed Centers for Disease Control and Prevention records to identify US investigations between January 1, 2009, and December 31, 2018, involving laboratory-confirmed contamination of manufactured medications and pharmacy-compounded preparations (P-CPs), using relevant search terms (eg, “medication contamination”). Laboratory confirmation was defined as identification of a pathogen from a manufactured medication or P-CP. We determined the number and type of patient infections associated with these investigations, the number of states involved, pathogens identified, type of medication (sterile or nonsterile), route of administration, and how the contamination event was first identified. We excluded investigations when the mode of production was unknown. Results: We identified 20 investigations in at least 20 states involving laboratory-confirmed contamination of manufactured medications (n = 12) and P-CPs (n = 8). Patient infections were identified in 16 (80%) investigations (9 involving manufactured medications and 7 involving P-CPs) resulting in at least 1,183 infections and at least 73 deaths. Bloodstream infections were the most common infection type (n = 7, 44%). Waterborne pathogens (eg, Serratia marcescens, Burkholderia cepacia) were cultured from medications in 83% (n = 10) of investigations involving manufactured medications and 75% (n = 6) of investigations involving P-CPs. Contamination of sterile pharmaceutical products occurred in 14 (70%) investigations; 11 (79%) of these involved injectables. Information regarding how contaminated pharmaceuticals were first identified was documented for 18 investigations; most cases (n = 14, 78%) started with investigation of patient infections by facilities, public health, or both, which led to laboratory testing of pharmaceuticals and confirmation of contamination. Conclusions: The events summarized here likely underestimate the frequency of intrinsic contamination of pharmaceutical products in the United States. These events can have devastating consequences that impact patients across the country. Waterborne pathogens appear to be the most frequently identified source of contamination in both manufactured medications and P-CPs.

Detection, investigation, control, and prevention of pharmaceutical contamination events benefit from collaboration between state and federal public health authorities; without public health intervention. Such contamination may have gone undetected and could have harmed additional patients.

Funding: None

Disclosures: None