Getting the Point of Injection Safety

Transcription

1 Getting the Point of Injection Safety Barbara Montana, MD, MPH, FACP Medical Director Communicable Disease Service Outbreak of Enterococcus faecalis endocarditis associated with an oral surgery practice New Jersey, Bacterial Endocarditis Infection of the heart valve(s)/lining Occurs when bacteria get into bloodstream Can result in damage to the heart valves and heart failure Clumps of bacteria on heart can break off and travel Who Gets Bacterial Endocarditis? Healthy people can get endocarditis Increased risk People over age 60 Males Injection drug users People who have intravascular (IV) catheters People on dialysis People with immune problems (HIV, cancer) Heart disease Prosthetic valves Specific congenital problems History of endocarditis Valvulopathy after cardiac transplant What Bacteria Causes Endocarditis? Staphylococcus aureus 31% Viridans group streptococci 17% Enterococci 11% Coagulase-negative staphylococci 11% Streptococcus bovis 7% Other streptococci 5% Non-HACEK gram negative 2% Fungi 2% HACEK 2% Enterococcus spp. Gram positive cocci 17 species E. faecalis, E.faecium, etc. Present in the gastrointestinal and genitourinary tract of humans Survive harsh environmental conditions - drying, high temperatures, and antiseptics 2 nd 3 rd most common cause of healthcareassociated infections Cause 5 10% of community-acquired endocarditis; 30% of healthcare-associated endocarditis Murdoch, DR, Corey GR, Hoen B, et al, Arch Intern Med. 2009;169(5):463 1

2 Endocarditis from Dental Procedures Overall risk 1 case per 14 million dental procedures Associated with underlying heart disease 700 species of bacteria in the mouth Viridans streptococci 30% of flora Enterococci NOT part of normal oral flora Enterococcus faecalis bacteremia and endocarditis NOT associated with dental procedures Who gets enterococcal infections? Increased risk for people with Indwelling catheters Cancer Gastrointestinal disease Genitourinary disease Renal failure on chronic dialysis N.J.A.C. 8:57, Reportable Communicable Diseases Single cases of endocarditis are not reportable to public health authorities Single cases of enterococcal infections are not reportable to public health authorities Outbreaks or suspected outbreaks of any communicable disease are immediately reportable to public health authorities The Initial Report October 20, 2014 an astute healthcare provider reported to NJDOH two cases of bacterial endocarditis caused by E. faecalis Patients 17 and 23 years of age without underlying risk factors for enterococcal infections or high risk conditions for endocarditis Both had procedures at same oral surgery practice November 6, 2014 NJDOH learned of a third endocarditis case reported to Board of Dentistry also E. faecalis Support for Investigation 3 cases of endocarditis associated with single oral surgery practice highly unusual 3 cases of endocarditis associated with single oral surgery practice with the same organism highly unusual 3 cases of Enterococcus faecalis endocarditis, an organism not typically associated with bacteremia following oral surgery, extremely unusual Support for Investigation Enterococcus spp leading cause of healthcare associated infections Visit to assess infection prevention practices warranted since these infections might be healthcare associated 2

3 November 14, 2014 Site Visit Deviations from recommended practices observed Summary of key injection safety breaches Using single use vials of medication for more than one patient Pre-drawing of medication well in advance Storing medication in cabinet in bathroom Preparing and storing of multiple use vials in patient treatment area; no beyond use date noted on vials Unwrapping syringes and intravenous catheters well in advance of use Poor hand hygiene Using non-sterile products during sterile procedures Non-sterile alcohol Scotch tape for intravenous catheters Do not use single use vials for more than one patient Minimize use of multiple use vials Do not keep multiple use vials in the patient treatment area Multiple use vials must have beyond use date 28 days from opening Needles, syringes and other sterile items must be opened at the time of use Any single use item opened in a patient treatment area must be patient dedicated Medication should be prepared as close to the time of use as possible Medication from single use vials must be used within one hour of preparation 3

4 Alcohol for sterile procedures and for wiping the tops of vials must be from sterile individual packets Intravenous site covers must be sterile medical products Medication must be prepared on clean surface, away from contaminated items Single use vials lack antimicrobial agents and can support microbial growth January 13, 2015 Site Visit Corrective action taken from initial site visit Remaining issues Multiple use vials in patient treatment area Multiple use vials without beyond use date Alcohol swabs not sterile Alcohol dispensers still present Unwrapped catheters in procedure room Poor hand hygiene 4

5 Case Finding Record Review NJDOH obtained records from the oral surgery practice for 2013 and 2014 NJDOH also obtained data collected through the New Jersey Hospital Discharge Data Collection System for the same period Data from 2 sources underwent a matching algorithm using statistical software Case Finding Record Review Inclusion criteria Undergoing oral surgery procedure at the implicated practice within 6 months prior to hospital or emergency department visit Search narrowed to the following ICD-9 codes Endocarditis (421.) Enterococcus (041.04) Bacteremia (790.7) Sepsis and septicemia (995.9 and 038.) Other endocardium (424.) Oral abscess (528.3) Case Finding Record Review For all matched patients with the stipulated ICD-9 codes Medical records from treating healthcare providers were requested and reviewed Patients were contacted and interviewed using a standardized data collection instrument Oral surgery appointment records were reviewed Oral surgery procedure records were reviewed (one is missing) Case Identification Additional 12 cases identified through matching process Total of 15 cases associated with invasive oral surgery procedures at the implicated practice between December 2012 and August 2014 One of the 15 cases died due to complications of endocarditis and subsequent cardiac surgery Case Finding Call for Cases On March 2, 2016 NJDOH notified healthcare providers (targeting infectious disease specialists) of the outbreak via , telephone, and the Health Alert Network Healthcare providers asked to report any patient meeting the following criteria: E. faecalis bacteremia or endocarditis Absence of underlying condition placing at higher risk for enterococcal infections A history of invasive oral surgery procedure within six months prior to symptom onset Symptom onset after January 1,

6 Characteristics of the cases Median age at time of procedure 46 (range, 16 77) 73% (11) males 73% (11) under 60 80% (12) had cardiac surgery 8 valve replacement, 4 debridement/repair Number of endocarditis cases Number of known endocarditis cases associated with the oral surgery office by date of procedure, Procedure date of Patient #1 reported to BOD Procedure dates of Patients #10 &12 NJDOH notified of cases #10 and #12 All cases for whom anesthesia records were available (14/15) received propofol and midazolam 0 BOD New Jersey Board of Dentistry NJDOH New Jersey Department of Health Date of oral procedure (month-year) National Incidence Rates All endocarditis cases in U.S. ~ 15 per 100,000 persons per year ~1.5 cases per 100,000 due to Enterococcus spp Incidence rates at oral surgery practice 2013, 2014 and Comparison of Incidence Rates Incidence rate of enterococcal endocarditis among patients at the practice for was which is 248 times greater than national incidence Patients who received care during at the practice were 248 times more likely to have enterococcal endocarditis than people in the general population Summary 15 cases of endocarditis have been identified including one death The magnitude of this prolonged outbreak is likely to be greater than the number of cases detected Did not match for cases prior to January 1, 2013 Likely did not detect all cases through matching Visits with different ICD-9 codes Patients died without a diagnosis Patients sought care outside NJ The organism was most likely introduced into the patients bloodstreams during the administration of intravenous sedation Final report issued July 20,

7 Supporting Evidence Bacterial endocarditis following oral surgery is rare Viridans streptococci are most commonly associated with endocarditis following dental procedures Enterococcus is not part of the normal oral flora and is not associated with bacteremias following dental procedures Enterococcus is a hardy organism and survives in the environment Supporting Evidence Injection safety breaches that have been previously associated with disease transmission and outbreaks were identified at the office All of the identified cases had intravenous sedation at the practice none with local anesthesia only or exam/consult only Thank you! Barbara Montana, MD, MPH, FACP Barbara.Montana@doh.nj.gov