PEDIATRICS Vol. 119 No. 6 June 2007, pp. 1207-1209 (doi:10.1542/peds.2007-0787)
COMMENTARY |
Providing a Safety Net for Children: Investigating a Multistate Outbreak of Ralstonia mannitolilytica Related to a Contaminated Reusable Device
Department of Pediatrics, Columbia University, New York, New York; Department of Epidemiology, Morgan Stanley Children's Hospital of New York-Presbyterian, New York, New York
Jhung et al1 have reported a multistate outbreak of Ralstonia mannitolilytica that contaminated a Vapotherm 2000i, a reusable oxygen-warming device. As of 2005, the Vapotherm 2000i was used in 900 American hospitals, primarily in NICUs.1 In the outbreak described in their report, 38 children (5 days to 7 years of age) were infected or colonized with R mannitolilytica; fortunately, there was only 1 death attributed to this very unusual pathogen. In the case-control study performed (4 controls per case-subject matched on length of hospital stay), the case-subjects were 18-fold more likely than control subjects to have been exposed to a Vapotherm 2000i.1 To confirm the association of this outbreak with the Vapotherm 2000i, molecular analysis of isolates from 18 hospitals in 12 states was performed by investigators from the University of Michigan. These studies (1) confirmed the identity of this unusual species, (2) determined that putative case-subjects were infected/colonized with the same clone of R mannitolilytica, (3) determined that the clone recovered from the patients was also recovered from the Vapotherm 2000i, and (4) documented the genetic diversity of R mannitolilytica. These epidemiologic and molecular data were the basis of the product recall (the Vapotherm 2000i was recalled from use in December 2005).
Consider the magnitude of the investigation and the implications of recalling a product in widespread use in hospitals. The magnitude of the investigation is reflected by the lengthy list of coauthors and acknowledgments in the Jhung et al report. Coauthors included members of the Centers for Disease Control and Prevention (CDC) Division of Healthcare Quality Promotion, infection-control practitioners from 2 children's hospitals, and epidemiologists from the Philadelphia health department, and an additional 22 children's hospitals and health departments were listed in their acknowledgements. The list is open testimony to the commitment of these institutions to improve the safety of health care for children.
It is fair to say, generally, that outbreak investigations, case-control studies performed to assess potential risk factors for infection, and molecular epidemiology studies to determine clonality are found within the pages of infection-control subspecialty journals. It is also fair to say that descriptions of emerging and/or unusual pathogens are found within the pages of infectious-diseases subspecialty journals. So why publish the description of an outbreak involving an unusual pathogen in a limited number of children and the measures taken to confirm the role of a reusable device in the journal Pediatrics? This publication educates the pediatric community about the safety net cast by the infection-control community to protect children from health care–associated (formerly termed nosocomial) infections. Furthermore, this publication educates the pediatric community about the complex interactions between children's health care facilities, the CDC, the Food and Drug Administration (FDA), and industry.
Jhung et al have presented not only the complexities of outbreak investigations but also ably demonstrated the multiple levels of communication and collaboration required to ensure a productive investigation. Throughout the United States, infection-control practitioners and clinicians who care for high-risk pediatric patients perform surveillance for health care–acquired infections and colonization. Colonization can be as significant as infection; colonized children can serve as reservoirs of potential pathogens for other vulnerable patients. Thanks to continual surveillance in individual institutions, infection-control practitioners acquire a tremendous amount of pattern recognition. One child infected (or colonized) with an unusual pathogen signals a fluctuation in the seismographic recording; 2 cases trigger a reading akin to a tremor and often prompt a realignment of priorities in case there is an earthquake brewing; and 3 such children require activation of an "emergency response team."
As illustrated by their report, health care facilities communicate epidemiologically significant events to their local health departments, who in turn invite the CDC to assist in outbreak investigations, particularly when a multistate outbreak is suspected. Multiple examples of such investigations have been performed by the CDC in efforts to document the links between specific exposures to potential pathogens and illness. Recent examples include a multistate outbreak of Enterobacter sakazakii linked to contaminated infant formula,2 a multistate outbreak of Pseudomonas fluorescens linked to contaminated normal saline syringes used to flush indwelling central venous catheters,3 and a multistate investigation that explored the increased rate of bloodstream infections, particularly with Gram-negative bacilli, associated with continuous intravenous therapy for pulmonary hypertension.4 Each of these examples identified new risk factors and serve to illustrate the complexities of ensuring safe health care for increasingly vulnerable patients who are increasingly dependent on technology.
Although the manufacturing and disinfecting protocols for the Vapotherm 2000i are somewhat intricate, it is worthwhile to ponder them. All health care institutions devote considerable resources to ensuring appropriate levels of disinfection and sterilization.5 Patient care items and equipment are divided into 3 categories (critical, semicritical, and noncritical) that reflect the degree to which items and equipment confer a risk of infection. Critical items and equipment require sterilization, because such items come into contact with sterile tissues or the vascular system and any level of contamination confers a risk of infection with spores, mycobacteria, fungi, viruses, and/or bacteria. Examples of such items are surgical instruments, urinary tract catheters, and vascular catheters. Semicritical items contact mucous membranes or nonintact skin and require high-level disinfection with processing that kills mycobacteria, fungi, viruses, and bacteria. Examples of such items include respiratory therapy equipment, bronchoscopes, and endoscopy equipment. Noncritical items (eg, blood pressure cuffs and crutches) only come into contact with intact skin and, thus, are associated with a minimal risk of infection to the patient and require low-level disinfection. Thus, the Vapotherm 2000i is a semicritical medical device, and its reusable components must undergo high-level disinfection between patients. However, the manufacturer's instructions mistakenly specified low-level disinfection between patients. In addition, the filter that separates air to the patient from the water used to humidify the air was intended to serve as a total biological barrier; thus, tap water was used to fill the chamber. Tap water is not sterile and has been linked to infections with Legionella, mycobacteria, enteric pathogens, noroviruses, and cryptosporidium.6 Many of these potential pathogens form biofilms within the water pipes and tap that cannot be eradicated. The investigators never identified the "smoking gun" in that Ralstonia was not recovered from the tap water at the manufacturing plant, but it is notable that these cultures were performed months after the contaminated equipment was manufactured, and other potential pathogens (Sphingomonas paucimobilis and Burkholderia cepacia) did grow from the tap water.1
Around the world, the health care community is struggling with the safety of reusable devices that are intended to help reduce health care costs and reduce waste. Although the tremendous cost of single-use items for patients is duly noted, the potential risks associated with reusable devices are not fully quantified. Furthermore, many institutions and professional societies are also struggling with the safe reprocessing of single-use devices. Without this publication and others like it, the pediatric community would be unable to monitor and measure the risk benefits of reusable patient care items and equipment.
Finally, the Jhung et al report disclosed another significant factor that contributed to this outbreak: the mechanism whereby the FDA clears new medical devices for marketing. The FDA has a premarket approval process that requires demonstration of safety and effectiveness of certain new or high-risk devices before approval for marketing. In contrast, the FDA has a 501(k) process whereby a new medical device can be marketed if deemed to perform equivalently to an approved, currently marketed device and has the same intended use. According to the FDA's Report on New Medical Devices Approved in Fiscal Year 2000, the vast majority of medical devices (nearly 99%) were cleared for usage by the 501(k) process.7 The Jhung et al investigation highlights the potential noncomparability of new devices as a result of reprocessing issues. Thus, the FDA, in recognition of the importance of infection-control principles, has made device sterilization a priority for improving the 501(k) submission process.8
In summary, Jhung et al carefully outlined the productive collaboration between children's health care institutions, governmental agencies, and industry. Their report traced the complex steps taken from the clinical observations of astute infection-control practitioners to reporting potential outbreaks to local health departments to engaging the CDC and conferring with the FDA. Also, as their report detailed, progress can only be made when the manufacturer is involved as a participant in improving health care. Finally, each institution must have a careful process whereby all new patient care items and equipment are brought into usage with consideration for the infection-control implications.
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FOOTNOTES |
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Accepted Mar 16, 2007.
Address correspondence to Lisa Saiman, MD, MPH, 622 W 168th St, PH 4 West, Room 470, New York, NY 10032. E-mail: ls5{at}columbia.edu
The author has indicated she has no financial relationships relevant to this article to disclose.
Opinions expressed in these commentaries are those of the authors and not necessarily those of the American Academy of Pediatrics or its Committees.
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REFERENCES |
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 TOP REFERENCES |
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- Jhung MA, Sunenshine RH, Noble-Wang J, et al. A national outbreak of Ralstonia mannitolilytica associated with use of a contaminated oxygen-delivery device among pediatric patients.
Pediatrics. 2007;119
:1061
–1068
[Abstract/Free Full Text] - Centers for Disease Control and Prevention. Enterobacter sakazakii infections associated with the use of powdered infant formula: Tennessee, 2001. MMWR Morb Mortal Wkly Rep. 2002;51 :297 –300[Medline]
- Centers for Disease Control and Prevention. Pseudomonas bloodstream infections associated with a heparin/saline flush: Missouri, New York, Texas, and Michigan, 2004–2005. MMWR Morb Mortal Wkly Rep. 2005;54 :269 –272[Medline]
- Centers for Disease Control and Prevention. Bloodstream infections among patients treated with intravenous epoprostenol or intravenous treprostinil for pulmonary arterial hypertension: seven sites, United States, 2003–2006. MMWR Morb Mortal Wkly Rep. 2007;56 :170 –172[Medline]
- Liang JL, Dziuban EJ, Craun GF, et al. Surveillance for waterborne disease and outbreaks associated with drinking water and water not intended for drinking: United States, 2003–2004. MMWR Surveill Summ. 2006;55 :31 –65[Medline]
- Rutala WA, Weber DJ. Disinfection and sterilization in health care facilities: what clinicians need to know. Clin Infect Dis. 2004;39 :702 –709[CrossRef][Web of Science][Medline]
- Snider S. FDA Report on New Medical Devices Approved in FY 2000. Rockville, MD: Food and Drug Administration; 2000. Available at: www.fda.gov/bbs/topics/ANSWERS/ANS01047.html. Accessed March 21, 2007
- US Food and Drug Administration. FY 2005 CDRH annual report. Available at: www.fda.gov/cdrh/annual/fy2005. Accessed March 21, 2007
PEDIATRICS (ISSN 1098-4275). ©2007 by the American Academy of Pediatrics
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