The purposes of this study were to provide national estimates of emergency department (ED) visits for medical device-associated adverse events (MDAEs) in the pediatric population and to characterize these events further.
ED medical record reports from the National Electronic Injury Surveillance System All Injury Program database from January 1, 2004, through December 21, 2005, were reviewed. MDAEs among pediatric patients were identified, and data were abstracted. National estimates for pediatric MDAEs were determined according to medical specialty, device category and class, injury diagnosis, and patient characteristics and outcome.
The total estimated number of pediatric MDAEs during the 24-month period was 144799 (95% confidence interval: 113051–183903), involving devices from 13 medical specialties. Contact lenses accounted for most MDAEs (23%), followed by hypodermic needles (8%). The distribution of MDAEs according to medical specialty varied according to age subgroup. The most-prevalent types of injuries included contusions/abrasions, foreign-body intrusions, punctures, lacerations, and infections. The most-frequently affected body parts were the eyeball, pubic region, finger, face, and ear. The majority of pediatric MDAEs involved class II (moderate-risk) devices. The incidence of pediatric MDAEs decreased with increasing age from early to late childhood and then spiked after 10 years of age. More girls than boys were affected at older ages (16–21 years) and more boys than girls at younger ages (≤10 years). Hospitalizations were more likely to involve invasive or implanted devices.
This study provides national estimates of pediatric MDAEs resulting in ED visits and highlights the need to develop interventions to prevent pediatric device-related injuries.
Comments
The reporting of MDAEs with respect to tympanostomy tubes
September 8, 2010
Lewis R. First, MD Editor Journal of Pediatrics American Academy of Pediatrics P.O. Box 927 Elk Grove Village, IL 60009-0927
Dear Dr. First:
RE: Wang et al. : “Emergency Department Visits for Medical Device- Associated Adverse Events Among Children” PEDIATRICS 126;2: 2010 (247-259)
Wang et al. report that “…the device category with the greatest estimated number of MDAEs (Medical Device Adverse Events) for children < 5 years of age was tympanostomy tubes.” This characterization is inaccurate and misleading on several levels. This communication and the parallel letter from Wang et al. in response to our concerns provide a unique opportunity to correct any clinical misunderstandings in the value of, or the reporting of MDAEs with respect to tympanostomy tubes.
“Device failure” as epidemiologically defined in this study for ear tubes was identified by ear drainage, or otorrhea. Such an all-inclusive designation differs significantly from a reasonable clinical definition of “device failure” in our opinion. This definition is for the most part clinically inaccurate. Otorrhea following tympanostomy tube insertion can be both intended and unintended. While there may be unexpected foreign body reactions or allergic reactions to tympanostomy or pressure- equalizing tubes (PETs), post-tube otorrhea is common, and usually beneficial, promoting removal of effusion from the middle ear and mastoid, rather than risking hearing, balance, peripheral neuropathic, and central nervous system complications from acute or chronic otitis media. Very different causes of PET otorrhea, such as water exposure and upper- respiratory infections, may predispose to post-tube otorrhea, and therefore, all otorrhea as such should not be unconditionally considered a “complication” of this device but rather an often intended consequence of the device.
We appreciate that Wang et al. express as much in their parallel letter in this Volume. We also appreciate and anticipate the opportunity to collaboratively reexamine the definitions and criteria for MDAEs with respect to PETs specifically and in Otolaryngology-Head and Neck Surgery in general. This opinion is consistent with both clinical and health policy of the AAO-HNS and has been reviewed and approved by its leadership. An interdisciplinary approach to this important issue is warranted and welcomed.
Respectfully Submitted,
Frank L. Rimell, MD Udayan Shah, MD, FACS, FAAP, The Medical Devices and Drugs Committee of the American Academy of Otolaryngology-Head and Neck Surgery Foundation
Full Committee Listing:
Robert M. Boucher, MD, MPH Frank L. Rimell, MD Michael Cho, MD Perry M. Santos, MD, MS Riccardo D’Eredita’, MD Udayan K. Shah, MD, FACS, FAAP Ann L. Edmunds, MD David L. Steward, MD Prajoy P. Kadkade, MD Kevin D. Pereira, MD, MS (ORL) Martin J. Citardi, MD Maurice Roth, MD Anand K. Devaiah, MD Scott R Schoem, MD Steven M. Gold, MD Gordon J. Siegel, MD Ofer Jacobowitz, MD, PhD. Howard Stupak, MD Jodi M. Kornak, MD Eric A. Mann,MD,PhD.
Conflict of Interest:
None declared
Reponse to letter from MDDC, AAO-HNS
In response to the letter from The Medical Devices and Drugs Committee of the American Academy of Otolaryngology-Head and Neck Surgery Foundation regarding our paper entitled “Emergency Department Visits for Medical Device-Associated Adverse Events Among Children” PEDIATRICS 126; 2: 2010 (247-259)”, it should be noted that the purpose of the paper is to present the scope of pediatric medical device adverse events (MDAEs) seen in the Emergency Department (ED). In the study, an MDAE is defined as a problematic event which a medical device was considered to have caused or to have contributed. An MDAE may result from device failure, but also from use error, unintentional injury, or other cause, despite the intended therapeutic application of the device.
We do appreciate the concerns raised by the Academy that in some cases the tympanostomy or pressure-equalizing tube (PET) may not have been the underlying cause of otitis media, although it did contribute to the occurrence of otorrhea by allowing the middle ear fluid to drain; hence, these events met our criteria for an MDAE. In addition, the adverse events in parentheses adjacent to each device type in Table 1 (e.g., "device- associated otitis media" following "Ear tubes") are intended as prevalent examples indicated by the ED physician. It is not our intent to claim that all tube otorrhea necessarily impugns the indications or benefits of PET placement, but rather to note that otorrhea through PETs is seen often in children in the Emergency Department and reported as an MDAE as currently defined. Although many PET cases only indicated otorrhea, the study found a number of cases that clearly indicated ear infection/otitis media, pain, or trauma facilitated by tube blockage, conduit for water, or displacement.
To present the data in a more balanced manner, we would like to revise Table 1 (attached) by replacing "device-associated otitis media" with "otorrhea", which is the most prevalent event associated with PETs in our data and is also a commonly reported complication of tympanostomy tube placement [1-3]. As for the cause of the otorrhea, it is important to emphasize (as noted in the limitations of the study in the discussion section) that the study was not designed to establish the cause of the MDAE which may, in fact, be related to an underlying patient disease.
Finally, we welcome collaboration with the Academy to examine the nature of MDAEs with respect to PETs. As briefly mentioned in the discussion section of the paper, this study is just an initial effort to examine medical device safety issues in the pediatric population using NEISS data.
Respectfully Submitted,
Cunlin Wang, MD, PhD
Brock Hefflin, MD, MPH
Judith Cope, MD, MPH
Thomas Gross, MD, MPH
1. McLelland CA. Incidence of complications from use of tympanostomy tubes. Arch Otolaryngol. 1980;106:97–99
2. Ah-Tye C, Paradise JL, Colborn DK. Otorrhea in Young Children After Tympanostomy-Tube Placement for Persistent Middle-Ear Effusion: Prevalence, Incidence, and Duration. Pediatrics 2001;107(6): 1251-1258
3. Hochman J, Blakley B, Abdoh A, Aleid H. Post-tympanostomy tube otorrhea: a meta-analysis. Otolaryngol Head Neck Surg. 2006 ; 135(1):8-11.
Conflict of Interest:
None declared
Lack of the mention of the adverse events related to acupuncture practices in pediatrics
To the Editor: Dr. Cunlin Wang, et al. reported the estimation of the frequency of the medical device-associated adverse events (MDAEs) among children in Pediatrics published online Jul 26, 2010.1 This is a laborious work in the field of pediatrics in the emergency department. It shows that the second reason of MDAEs was hypodermic needles. In recent years, the use of acupuncture for pediatric patients has not been negligible. 2, 3 However, adverse events related to acupuncture practice in children are less commonly4 and rarely reported. In this study, there is no category of acupuncture needle or devices and no description if the MDAEs by hypodermic needles include the adverse events caused by acupuncture needle or not. Authors of this important article should supply the details of MDAEs of hypodermic needles. There is a unique style of acupuncture for children in Japan. In this special treatment style, the needles are shaped and used not for penetrating the patients�f skin.5 So far, there is no report on adverse events of pediatric acupuncture in Japan. The survey of adverse events is imperative to improve the traditional way of acupuncture.6 We are really interested in the evidence of adverse events of acupuncture practice in pediatric service and hope to hear from the authors.
Reference
1. Wang C, Hefflin B, Cope JU, Gross TP, Ritchie MB, Qi Y, et al. Emergency Department Visits for Medical Device-Associated Adverse Events Among Children. Pediatrics. 2010. 2. Jean D, Cyr C. Use of complementary and alternative medicine in a general pediatric clinic. Pediatrics. 2007;120(1):e138-141. 3. Gold JI, Nicolaou CD, Belmont KA, Katz AR, Benaron DM, Yu W. Pediatric acupuncture: a review of clinical research. Evid Based Complement Alternat Med. 2009;6(4):429-439. 4. Jindal V, Ge A, Mansky PJ. Safety and efficacy of acupuncture in children: a review of the evidence. J Pediatr Hematol Oncol. 2008;30(6):431-442. 5. Kobayashi A, Uefuji M, Yasumo W. History and Progress of Japanese Acupuncture. Evid Based Complement Alternat Med. 2008. 6. Yamashita H, Tsukayama H, White AR, Tanno Y, Sugishita C, Ernst E. Systematic review of adverse events following acupuncture: the Japanese literature. Complement Ther Med. 2001;9(2):98-104.
Conflict of Interest:
None declared