December 7, 2015
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Comments of members of the Patient, Consumer, and Public Health Coalition
on Proposed Rule
“General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet”
[Docket No. FDA-2015-N-0701]
Members of the Patient, Consumer, and Public Health Coalition support strong safety standards for pediatric medical cribs and medical bassinets. Strong safety standards will prevent infants from dying due to suffocation or strangulation, and will prevent injuries such as pinching or lacerations.
The FDA’s proposed rule would allow “prescription use of pediatric medical cribs and bassinets,” and it would include the CPSC’s mattress flammability standards. However, the proposed rule does not require companies to provide proof of safety to the FDA; in addition, the need for pediatric medical cribs with drop-side rails “outside of traditional health care settings”1 has not been established. Our detailed concerns about the proposed rule are listed below.
Need for drop-side rail cribs not established
The Federal Register notice states, “Although drop-side cribs for non-medical purposes are now prohibited [by the Consumer Product Safety Commission], there is still a need for pediatric medical cribs with drop-side rails inside and outside of traditional health care settings.”1 However, the documentation for this “need” is an FDA MedSun survey of only “nine healthcare professionals,” which did not include any pediatricians. Drop-side rail cribs deserve greater scrutiny because the CPSC has received “reports of deaths of children attributable to entrapment and/or strangulation caused by the malfunctioning of drop-side rail cribs.”1 The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database shows 516 adverse events associated with medical cribs “including 15 serious injuries” from 2005 to 2015.1 Healthcare experts agree that the MAUDE database undercounts adverse events.
Despite their enthusiasm, respondents of this small survey noted problems with the drop-side cribs. They said that parents forget “to pull the rails all the way up…not properly locking the rails into place.” Respondents also said that even though hospitals provide education about drop-side rail cribs to parents “it continues to be a challenge to reinforce proper use of side rails to prevent harm and maintain patient safety” (emphasis added).2 The nine surveyed health professionals stated that drop-side cribs were needed to allow fast access to patients in emergency situations. They said with fixed side rail cribs, response time would be delayed because they “would have to reach over the rails to get to the patient.” They are assuming that putting down the side of a drop-side crib is faster than reaching over the rails, but they do not provide any evidence to support that assumption. In fact, the nine healthcare professionals surveyed said that their hospitals only had drop-side cribs, so that they had no cribs with fixed rails to provide a comparison.
Survey respondents also noted that a patient in a fixed side crib “would need to be moved to an open surface to perform CPR.” Once again, there is no evidence that this is such a problem that it justifies the risks that would ensue if drop-side cribs became available outside a hospital setting.
Given the lack of scientific evidence that drop-side rail cribs provide important benefits in hospital settings, it is especially important that these cribs be tested to ensure they are safe.
Drop-side cribs and bassinets should be required to be proven safe and not be exempted from premarket notification (510(k))
In the proposed rule, FDA would rename pediatric hospital beds as pediatric medical cribs and medical bassinets and classify them as moderate risk devices exempted from premarket notification. It should be noted that the vast majority of exempted devices are low risk (class I) devices, not moderate risk devices. Drop-side rail crib devices, which have been documented to cause suffocation, strangulation, or lacerations (or in the case of the bassinet, the risk of tipping over) should not be exempt from 510(k) (premarket notification) review. In fact, FDA should require studies to quantify the risks and benefits of drop-side rail cribs compared to fixed rail cribs, for example, by determining the amount of time saved in simulated emergency situations.
FDA approval standards for drop-side rail cribs should be higher for those used outside the hospital setting. Prescriptions will not prevent drop-side rail cribs from being used without prescriptions.
The major problem with approving these cribs for non-hospital settings is that there is no way to prevent them from being used in situations where the risks clearly outweigh the benefits, such as for infants who are not in a precarious medical condition. In fact, the MedSun survey stated, “The average age of their [hospital] pediatric cribs is between 10 and 15 years old”2 with some as old as 20 years old. It is clear that once drop-side rail cribs are used “outside of traditional health care settings,” they are likely to be reused for many different infants over a period of many years, putting many infants at unnecessary risk of injury or death. Although the proposed rule would allow drop-side rail cribs in “homes and day cares only when medically necessary,”1 the term “medically necessary” is not defined and no enforcement mechanism is proposed to limit their use to medically necessary situations, nor is any enforcement strategy likely to be effectively implemented.
If these beds are available by prescription, insurance is likely to pay for them as medical devices. That is how, for example, a woman who has had a Cesarean-section (25% of all births in the US today) might get a drop-rail crib that would cost her less than getting a regular crib from a store. Then, after her c-section is healed, she is likely to continue to use the crib (at which point the risks outweigh the benefits) for her baby and for subsequent babies, and also likely to give that crib away to friends or family, or sell it to a family daycare center, or on Craigslist.
In the Risks to Health section, the Federal Register notice states, “certain cribs may peel or crack and may expose pediatric patients to substances or materials that may be toxic.”1 The MedSun survey notes that “many cribs have a canopy or bubble top made of vinyl or hard plastic.”2 Since some plastics contain endocrine disrupting chemicals that get into the air and dust in the room, these tops need to be tested to ensure that they are not harmful to babies; this is another reason why pediatric cribs should not be exempt from 510(k) testing requirements.
Over the last 10 years, FDA has recorded 40 adverse events with medical bassinets. These include bassinets tipping over due to malfunctions such as casters or wheels not working, and cracking of plastic materials that may result in cuts to babies and caregivers. It is well known that adverse events for medical devices are underreported. Although medical bassinets are less likely to have serious adverse reports than drop-side cribs, the risk of tipping over is significant. FDA’s proposed mitigation to prevent tip overs (a warning label on the front) is inadequate. The warning should be large, permanent, and on all sides of the bassinet.
Concerns with flame retardant mattresses
The proposed rule on medical cribs and bassinettes would include the CPSC’s mattress flammability standards, but the health risks of numerous flame retardants are well documented., ,  Although preventing crib fires is important, it is equally important for the FDA to protect infants against other health risks. By relying on CPSC rather than weighing in on the safety of mattresses, the FDA’s proposed rule fails to provide the best safeguards for infants for their mattresses as well as their cribs and bassinets.
FDA should test drop-rail cribs for safety, since there are well-established and serious risks. We oppose the FDA proposed rule as currently written because it would not require any safety testing data be reviewed by the FDA. However, even if that part of the proposed rule were revised, the proposed rule would still create an enormous loophole that would allow widespread use of cribs outside of healthcare settings, as noted above. This is of particular concern if the cribs were available in daycare settings, where there is often limited monitoring of babies sleeping in rooms separate from the staff.
We also urge large, permanent warnings on all sides of medical bassinets, rather than just one side.
Because of the safety and health concerns listed above, and the lack of evidence of when the benefits of drop-side rail medical cribs outweigh the risks, the following members of the Patient, Consumer, and Public Health Coalition do not support the FDA’s proposed rule as currently written for medical cribs and bassinets.
Connecticut Center for Patient Safety
MRSA Survivors Network
National Center for Health Research
Center for Science and Democracy at the Union of Concerned Scientists
Washington Advocates for Patient Safety (WAPS)
The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 or at email@example.com
 Federal Register (October 8, 2015). Food and Drug Administration, “General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet.” https://www.federalregister.gov/articles/2015/10/08/2015-25627/general-hospital-and-personal-use-devices-renaming-of-pediatric-hospital-bed-classification-and
 Med Sun: Newsletter #66 (November 2011). “Pediatric Hospital Cribs: Med Sun Small Sample Survey Summary.” http://www.fda.gov/downloads/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/Newsletters/UCM422131.pdf
 NIH’s Web site (accessed December 2, 2015). “Cesarean Section.” https://www.nlm.nih.gov/medlineplus/cesareansection.html
 Hoffman K, Butt CM, Chen A, Limkakeng AT Jr, Stapleton HM (November 19, 2015). High Exposure to Organophosphate Flame Retardants in Infants: Associations with Baby Products. Environ Sci Technol. http://www.ncbi.nlm.nih.gov/pubmed/26551726