Crib Bumpers: Maryland’s Experience

1. Crib Bumpers: Maryland’s Experience Joshua M. Sharfstein, MD Andrea C. Gielen, ScD October 26, 2016

2. About the Presenters Andrea C. Gielenis a Professor in the Department of Health, Behavior, and Society at the Johns Hopkins Bloomberg School of Public Health the Director of the Johns Hopkins Center for Injury Research and Policy. Considered one of the foremost public health experts on injury prevention in the country, she is the author of more than 125 scientific publications, has served as President of the Society for Advancement of Injury and Violence Research and received the Award for Excellence from the American Public Health Association. Joshua M. Sharfstein is Professor of the Practice in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health. He served as Secretary of Maryland’s Department of Health and Mental Hygiene from 2011 through 2014. Previously, he served as Commissioner of Health for Baltimore City. This presentation represents the views of Professors Gielen and Sharfstein and is not an official position of Johns Hopkins University.

3. Outline Maryland’s Experience Response to the CPSC Staff Response

4. Legal Standard in Maryland Title 22, Subtitle 5 of the Health-General Article of the Annotated Code of Maryland authorizes the Secretary of DHMH to regulate hazardous materials. Section 22-502(a) authorizes the Secretary to adopt rules and regulations to that declare as a hazardous material that the Secretary finds are intended for use by children that present an electrical, mechanical, or thermal hazard. The Secretary can further adopt rules and regulations to ban hazardous material if the material is a danger to public health and safety and proper labeling cannot protect the public health and safety adequately.

5. Maryland’s Process on Crib Bumpers

6. Maryland’s Process on Crib Bumpers

7. Maryland’s Process Multiple opportunities for public comment and scientific process. Evaluated both the potential benefit and potential risk of baby bumper pads. Benefit: Found no evidence of meaningful benefit at the ages recommended for infants. Harm: Found evidence of potentially lethal risk at the ages recommended for infants. Communication of baby bumper pad ban emphasized ABCs of safe sleep: Alone, Back, Crib. Media and public understood thoughtfulness and rationale for ban on sale of baby bumper pads.

8. Follow-Up Data Best place to look is Baltimore City. • Most unexplained deaths in infancy in the state • Public health focus on sleep-related deaths • Close tracking of sleep-related deaths According to Baltimore City Health Department, 2015 was lowest number of sleep-related deaths on record. 2015 also lowest infant mortality rate on record, and lowest African-American infant mortality rate on record.

9. Letter from Rebecca Dineen, Assistant Commissioner, Baltimore City Health Department

10. “Banning baby bumper pad sales in Maryland in 2013 was critical to Baltimore’s infant safe sleep campaign. The ban reinforces and promotes the messaging that babies must sleep alone. Baby bumper pads have been associated with suffocation and asphyxiation in young infants. In older infants, baby bumper pads are hazardous because infants can use them to climb out of a crib and fall. Baltimore’s SLEEP SAFE campaign has been used across Maryland and nationally to prevent infant deaths. Banning crib bumpers is critical to consistent messaging about how infants can sleep safely and reduces just one more risk factor that could result in an infant death.” -- Rebecca Dineen, Assistant Commissioner for Maternal and Child Health, Baltimore City Health Department

11. Response to CPSC staff document from an injury prevention perspective Precautionary principle: the potential threat of harm without evidence of sufficient benefit, even in the absence of definitive cause and effect relationships, is sufficient for action First and best injury countermeasure: eliminate the hazard Last and most difficult injury countermeasure: rely on constant vigilance by human beings to protect themselves and their loved ones

12. Specific Responses to CPSC Staff Document Method of considering only cases without any other potentially contributing factors does not have scientific merit. This method fails to recognize that many injury deaths have multiple causes and is not consistent with attribution in injury research. This method was rejected by Maryland’s advisory panel. This method still finds some fatal injuries to infants.

13. Brief Responses to CPSC Staff Document Attribution of benefit to crib bumpers is not credible. At the age of recommended use, there is essentially no risk of serious injury from a crib that meets CPSC standards. The staff’s analysis of limb entrapment did not address the age of the infants, a serious limitation. Maryland’s advisory panel considered the question of benefit and unanimously found there was no evidence of meaningful benefit.

14. Brief Responses to CPSC Staff Response The idea that parents will respond to a ban on sales by taking more dangerous action is not consistent with the response to the withdrawal of over-the-counter cough and cold medications for young infants. Research has documented substantial declines in poison control calls and Emergency Department visits for young infants following the withdrawal from the market of these products. Forrester MB. Effect of cough and cold medication withdrawal and warning on ingestions by young children reported to Texas poison centers. PediatrEmerg Care. 2012 Jun;28(6):510-3. doi: 10.1097/PEC.0b013e3182587b0c. Hampton LM, Nguyen DB, Edwards JR, Budnitz DS. Cough and cold medication adverse events after market withdrawal and labeling revision. Pediatrics. 2013 Dec;132(6):1047-54. doi: 10.1542/peds.2013-2236 Klein-Schwartz W, Sorkin JD, Doyon S. Impact of the voluntary withdrawal of over-the-counter cough and cold medications on pediatric ingestions reported to poison centers. Pharmacoepidemiol Drug Saf. 2010 Aug;19(8):819-24. doi: 10.1002/pds.1971.

15. Conclusion When there is no evidence of meaningful benefit, there is no justification for permitting a potentially lethal risk to infants. The CPSC should ban the sale of bumper pads. This ban should be coordinated with public health agencies, child safety organizations, and the American Academy of Pediatrics and should emphasize all important messages regarding safe sleep in a consistent and effective manner.