The
n e w e ng l a n d j o u r na l
of
m e dic i n e
new antibiotics, which are usually approved on Jonathan J. Darrow, S.J.D., J.D. the basis of trials showing noninferiority (rather Jerry Avorn, M.D. than superiority) to comparator agents. These Aaron S. Kesselheim, M.D., J.D. agents are also withdrawn from the market Brigham and Women’s Hospital MA more commonly than all other drug categories.4 Boston, [email protected] Early access can benefit patients, as Velleca asSince publication of their article, the authors report no furserts, but only if the drug is in fact effective — ther potential conflict of interest. the very question that only rigorous evidence 1. Investigational new drug, antibiotics, and biological drug development can answer. His contention that product regulations: procedures for drugs intended to treat lifethreatening and severely debilitating illnesses. Fed Regist 1988; patients and physicians “are in the best position 53:41516-24. to determine . . . how much risk they are will- 2. Food and Drug Administration. Guidance for industry: exing to take” may be true but minimizes the pedited programs for serious conditions — drugs and biologJuly 2013 (http://www.fda.gov/downloads/Drugs/Guidance crucial role of governmental benefit–risk assess- ics. ComplianceRegulatoryInformation/Guidances/UCM358301.pdf). ment of medications. Pressing treatment needs 3. Avorn J. The promise of pharmacoepidemiology in helping should be met with intensified development ef- clinicians assess drug risk. Circulation 2013;128:745-8. 4. Outterson K, Powers JH, Seoane-Vazquez E, Rodriguezforts, not new designations. Monguio R, Kesselheim AS. Approval and withdrawal of new Ricart clarifies the original indication of gem- antibiotics and other antiinfectives in the U.S., 1980-2009. J Law tuzumab ozogamicin, which is now reflected in Med Ethics 2013;41:688-96. the online version of our article. DOI: 10.1056/NEJMc1405337
Procedural Sedation and Analgesia in Children To the Editor: The video by Krauss et al. on procedural sedation and analgesia in children (April 10 issue)1 was thorough and detailed. However, I am very concerned that 45 seconds into the video an injection into intravenous tubing pushes air bubbles toward the patient. The potentially disastrous consequences of air in intravenous lines are well known, particularly in children with intracardiac shunts. William A. Scott, M.D. UT Southwestern Medical Center Dallas, TX
[email protected] No potential conflict of interest relevant to this letter was reported. 1. Krauss BS, Krauss BA, Green SM. Videos in clinical medi-
cine: procedural sedation and analgesia in children. N Engl J Med 2014;370(15):e23. DOI: 10.1056/NEJMc1405676
including a laryngeal mask airway of the appropriate size,1 an endotracheal tube, and a laryngoscope, which should also be available. Furthermore, the authors state that the administration of supplemental oxygen before and during sedation renders pulse oximetry ineffective with regard to early warnings of respiratory depression and recommend the use of capnography when supplemental oxygen is used. These aspects of the video could lead to the misconception that the observation of ineffective pulse oximetry in the early detection of hypoventilation is related to the administration of supplemental oxygen or that capnography cannot be used if supplemental oxygen is not used simultaneously. Nevertheless, supplemental oxygen is recommended before and during sedation, especially in pediatric patients, owing to their greater susceptibility to hypoxemia.
Samad E.J. Golzari, M.D. To the Editor: Pediatric patients have limited Hassan Soleimanpour, M.D. respiratory reserve and are susceptible to the Tabriz University of Medical Sciences rapid development of hypoxemia. The emergency Tabriz, Iran equipment mentioned by Krauss et al. does not [email protected] address the management of an unanticipated dif- Mahdi Najafi, M.D. ficult or impossible bag-mask–ventilation sce- Tehran University of Medical Sciences nario or the use of emergency airway devices, Tehran, Iran
90
n engl j med 371;1 nejm.org july 3, 2014
The New England Journal of Medicine Downloaded from nejm.org at UC SHARED JOURNAL COLLECTION on April 23, 2015. For personal use only. No other uses without permission. Copyright © 2014 Massachusetts Medical Society. All rights reserved.
correspondence No potential conflict of interest relevant to this letter was reported. 1. Golzari SE, Mahmoodpoor A. Laryngeal mask airway in
medical emergencies. N Engl J Med 2014;370:883.
DOI: 10.1056/NEJMc1405676
used in the absence of supplemental oxygen, an assertion with which we agree and do not contradict in our video. A complete discussion of the use of supplemental oxygen and capnography is beyond the scope of this video. Baruch S. Krauss, M.D. Boston Children’s Hospital
The Authors Reply: Scott expresses concern re- Boston, MA garding the presence of small bubbles in an in- [email protected] travenous line. The volume of air in our video is Benjamin A. Krauss well below thresholds specified by international University of Massachusetts Boston safety standards1 and well below those known to Boston, MA cause harm to the patient.2,3 We also note that Steven M. Green, M.D. current intravenous infusion sets include filters Loma Linda University Medical Center Loma Linda, CA that prevent the passage of air to the bloodSince publication of their article, the authors report no furstream. ther potential conflict of interest. Given the necessary brevity of the video, we 1. IEC 60601-2-24: medical electrical equipment — Part 2-24: omitted specific discussion of laryngeal mask particular requirements for the safety of infusion pumps and airways and laryngoscopes, noted by Golzari et al., controllers. Geneva: International Electrotechnical Commissince this equipment is rarely needed during sion, 1998 (https://www.document-center.com/standards/show/ IEC-60601-2-24). procedural sedation. We do state that “resuscita- 2. Levy I, Mosseri R, Garty B. Peripheral intravenous infusion tion equipment . . . must be immediately avail — another cause of air embolism. Acta Paediatr 1996;85:385-6. able” and specifically discuss the first-line res- 3. Wilkins RG, Unverdorben M. Accidental intravenous infusion of air: a concise review. J Infus Nurs 2012;35:404-8. cue device — a ventilation bag and mask. Golzari et al. also state that capnography can be DOI: 10.1056/NEJMc1405676
Monitoring Health Outcomes of Assisted Reproductive Technology To the Editor: During the past 35 years, assisted reproductive technology has been transformed from a miracle to a standard and common part of medical practice. Although this technology is believed to be safe and has resulted in more than 5 million infants born globally, rapid technological progress leading to treatment modifications makes it important to continually monitor the safety of assisted reproductive technology for the rapidly growing population of users of the technology and infants conceived with its use. Although many countries have national registries to monitor the use and effectiveness of assisted reproductive technology, they are typically not designed to collect data beyond delivery. In the United States, the Centers for Disease Control and Prevention (CDC) maintains the National ART (Assisted Reproductive Technology) Surveillance System (NASS), which collects limited information about treatment outcome (live
birth data are limited to plurality, infant sex, birth weight, and gestational age). Studying the long-term health outcomes of assisted reproductive technology is difficult owing to the relative infrequency of both the exposure to it and the outcomes of interest (e.g., birth defects, cancer, and developmental disorders) and to the sensitive nature of the fertility treatments. Our knowledge of the long-term effect of assisted reproductive technology on maternal and child health is thus quite limited.1 To better understand the effect of assisted reproductive technology on maternal and child health and to improve state-based surveillance, in 2001 the CDC’s Division of Reproductive Health initiated linkage of the NASS data with Massachusetts birth-certificate data. This small pilot project has since grown into the States Monitoring ART (SMART) Collaborative, which includes Massachusetts, Michigan, Florida, and
n engl j med 371;1 nejm.org july 3, 2014
The New England Journal of Medicine Downloaded from nejm.org at UC SHARED JOURNAL COLLECTION on April 23, 2015. For personal use only. No other uses without permission. Copyright © 2014 Massachusetts Medical Society. All rights reserved.
91
n e w e ng l a n d j o u r na l
of
m e dic i n e
new antibiotics, which are usually approved on Jonathan J. Darrow, S.J.D., J.D. the basis of trials showing noninferiority (rather Jerry Avorn, M.D. than superiority) to comparator agents. These Aaron S. Kesselheim, M.D., J.D. agents are also withdrawn from the market Brigham and Women’s Hospital MA more commonly than all other drug categories.4 Boston, [email protected] Early access can benefit patients, as Velleca asSince publication of their article, the authors report no furserts, but only if the drug is in fact effective — ther potential conflict of interest. the very question that only rigorous evidence 1. Investigational new drug, antibiotics, and biological drug development can answer. His contention that product regulations: procedures for drugs intended to treat lifethreatening and severely debilitating illnesses. Fed Regist 1988; patients and physicians “are in the best position 53:41516-24. to determine . . . how much risk they are will- 2. Food and Drug Administration. Guidance for industry: exing to take” may be true but minimizes the pedited programs for serious conditions — drugs and biologJuly 2013 (http://www.fda.gov/downloads/Drugs/Guidance crucial role of governmental benefit–risk assess- ics. ComplianceRegulatoryInformation/Guidances/UCM358301.pdf). ment of medications. Pressing treatment needs 3. Avorn J. The promise of pharmacoepidemiology in helping should be met with intensified development ef- clinicians assess drug risk. Circulation 2013;128:745-8. 4. Outterson K, Powers JH, Seoane-Vazquez E, Rodriguezforts, not new designations. Monguio R, Kesselheim AS. Approval and withdrawal of new Ricart clarifies the original indication of gem- antibiotics and other antiinfectives in the U.S., 1980-2009. J Law tuzumab ozogamicin, which is now reflected in Med Ethics 2013;41:688-96. the online version of our article. DOI: 10.1056/NEJMc1405337
Procedural Sedation and Analgesia in Children To the Editor: The video by Krauss et al. on procedural sedation and analgesia in children (April 10 issue)1 was thorough and detailed. However, I am very concerned that 45 seconds into the video an injection into intravenous tubing pushes air bubbles toward the patient. The potentially disastrous consequences of air in intravenous lines are well known, particularly in children with intracardiac shunts. William A. Scott, M.D. UT Southwestern Medical Center Dallas, TX
[email protected] No potential conflict of interest relevant to this letter was reported. 1. Krauss BS, Krauss BA, Green SM. Videos in clinical medi-
cine: procedural sedation and analgesia in children. N Engl J Med 2014;370(15):e23. DOI: 10.1056/NEJMc1405676
including a laryngeal mask airway of the appropriate size,1 an endotracheal tube, and a laryngoscope, which should also be available. Furthermore, the authors state that the administration of supplemental oxygen before and during sedation renders pulse oximetry ineffective with regard to early warnings of respiratory depression and recommend the use of capnography when supplemental oxygen is used. These aspects of the video could lead to the misconception that the observation of ineffective pulse oximetry in the early detection of hypoventilation is related to the administration of supplemental oxygen or that capnography cannot be used if supplemental oxygen is not used simultaneously. Nevertheless, supplemental oxygen is recommended before and during sedation, especially in pediatric patients, owing to their greater susceptibility to hypoxemia.
Samad E.J. Golzari, M.D. To the Editor: Pediatric patients have limited Hassan Soleimanpour, M.D. respiratory reserve and are susceptible to the Tabriz University of Medical Sciences rapid development of hypoxemia. The emergency Tabriz, Iran equipment mentioned by Krauss et al. does not [email protected] address the management of an unanticipated dif- Mahdi Najafi, M.D. ficult or impossible bag-mask–ventilation sce- Tehran University of Medical Sciences nario or the use of emergency airway devices, Tehran, Iran
90
n engl j med 371;1 nejm.org july 3, 2014
The New England Journal of Medicine Downloaded from nejm.org at UC SHARED JOURNAL COLLECTION on April 23, 2015. For personal use only. No other uses without permission. Copyright © 2014 Massachusetts Medical Society. All rights reserved.
correspondence No potential conflict of interest relevant to this letter was reported. 1. Golzari SE, Mahmoodpoor A. Laryngeal mask airway in
medical emergencies. N Engl J Med 2014;370:883.
DOI: 10.1056/NEJMc1405676
used in the absence of supplemental oxygen, an assertion with which we agree and do not contradict in our video. A complete discussion of the use of supplemental oxygen and capnography is beyond the scope of this video. Baruch S. Krauss, M.D. Boston Children’s Hospital
The Authors Reply: Scott expresses concern re- Boston, MA garding the presence of small bubbles in an in- [email protected] travenous line. The volume of air in our video is Benjamin A. Krauss well below thresholds specified by international University of Massachusetts Boston safety standards1 and well below those known to Boston, MA cause harm to the patient.2,3 We also note that Steven M. Green, M.D. current intravenous infusion sets include filters Loma Linda University Medical Center Loma Linda, CA that prevent the passage of air to the bloodSince publication of their article, the authors report no furstream. ther potential conflict of interest. Given the necessary brevity of the video, we 1. IEC 60601-2-24: medical electrical equipment — Part 2-24: omitted specific discussion of laryngeal mask particular requirements for the safety of infusion pumps and airways and laryngoscopes, noted by Golzari et al., controllers. Geneva: International Electrotechnical Commissince this equipment is rarely needed during sion, 1998 (https://www.document-center.com/standards/show/ IEC-60601-2-24). procedural sedation. We do state that “resuscita- 2. Levy I, Mosseri R, Garty B. Peripheral intravenous infusion tion equipment . . . must be immediately avail — another cause of air embolism. Acta Paediatr 1996;85:385-6. able” and specifically discuss the first-line res- 3. Wilkins RG, Unverdorben M. Accidental intravenous infusion of air: a concise review. J Infus Nurs 2012;35:404-8. cue device — a ventilation bag and mask. Golzari et al. also state that capnography can be DOI: 10.1056/NEJMc1405676
Monitoring Health Outcomes of Assisted Reproductive Technology To the Editor: During the past 35 years, assisted reproductive technology has been transformed from a miracle to a standard and common part of medical practice. Although this technology is believed to be safe and has resulted in more than 5 million infants born globally, rapid technological progress leading to treatment modifications makes it important to continually monitor the safety of assisted reproductive technology for the rapidly growing population of users of the technology and infants conceived with its use. Although many countries have national registries to monitor the use and effectiveness of assisted reproductive technology, they are typically not designed to collect data beyond delivery. In the United States, the Centers for Disease Control and Prevention (CDC) maintains the National ART (Assisted Reproductive Technology) Surveillance System (NASS), which collects limited information about treatment outcome (live
birth data are limited to plurality, infant sex, birth weight, and gestational age). Studying the long-term health outcomes of assisted reproductive technology is difficult owing to the relative infrequency of both the exposure to it and the outcomes of interest (e.g., birth defects, cancer, and developmental disorders) and to the sensitive nature of the fertility treatments. Our knowledge of the long-term effect of assisted reproductive technology on maternal and child health is thus quite limited.1 To better understand the effect of assisted reproductive technology on maternal and child health and to improve state-based surveillance, in 2001 the CDC’s Division of Reproductive Health initiated linkage of the NASS data with Massachusetts birth-certificate data. This small pilot project has since grown into the States Monitoring ART (SMART) Collaborative, which includes Massachusetts, Michigan, Florida, and
n engl j med 371;1 nejm.org july 3, 2014
The New England Journal of Medicine Downloaded from nejm.org at UC SHARED JOURNAL COLLECTION on April 23, 2015. For personal use only. No other uses without permission. Copyright © 2014 Massachusetts Medical Society. All rights reserved.
91
