FDA Certification on Bassinets - IMS has it!

As of January18, 2017 new classification regulations for Pediatric Hospital Beds to Pediatric Medical Cribs... "As a result of the risks to health and need for continued use of pediatric medical cribs in traditional health care settings and non-traditional settings, FDA is revising the identification for § 880.5140 (21 CFR 880.5140) to include only pediatric medical cribs, establishing special controls for these devices, and changing the name of the classification regulation. In addition, FDA has received adverse event reports from hospitals regarding incidents of medical bassinet tipping and improper cleaning of the basket or bed component that caused cracks and crazing, which have resulted in patient injury. Historically, medical bassinets have been regulated as pediatric hospital beds (§ 880.5140, product code NZG). As a result, this rule creates a separate regulation for medical bassinets and establishes special controls for this device type to provide a reasonable assurance of safety and effectiveness."  Source: Federal Register Website

The IMS bassinet by CartStrong has received the FDA Certification and § 880.5145 to reads as follows: Single BB 600.jpg

(a) Identification. A medical bassinet is a prescription device that is a small bed intended for use with pediatric patients, generally from birth to approximately 5 months of age. It is intended for medical purposes for use in a nursery, labor and delivery unit, or patient room, but may also be used outside of traditional health care settings. A medical bassinet is a non-powered device that consists of two components: The plastic basket or bed component and a durable frame with wheels, which holds the basket or bed component. The basket or bed component is a box-like structure, generally made of a clear, high impact-resistant plastic material, with an open top and four stationary walls to hold the pediatric patient. The frame can include drawers, shelving, or cabinetry that provides space to hold infant care items. The wheels or casters allow the bassinet to transport the infant throughout the care setting.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in sub part E of part 807 of this chapter subject to § 880.9. The special controls for this device are:

(1) The manufacturer must conduct performance testing to determine material compatibility with cleansing products labeled to clean the device. Testing must demonstrate that the cleaning instructions provided by the manufacturer do not cause crazing, cracking, or deterioration of the device;

(2) Manufacturers shall conduct performance testing to ensure the mechanical and structural stability of the bassinet under expected conditions of use, including transport of patients in the bassinet. Testing must demonstrate that failures such as wheel or caster breakage do not occur and that the device does not present a tipping hazard due to any mechanical failures under expected conditions of use; and

(3) Each device must have the following label(s) affixed:

(i) Adequate instructions for users to care for, maintain, and clean the bassinet; and

(ii) A warning label on at least two sides of the plastic basket or bed component with the following language in text of at least 9 millimeters in height:

WARNING: To avoid tipping hazards of this device, make sure that the basket or bed component sits firmly in the base and that all doors, drawers, and casters are secure."  Source: Federal Register Website

Downloadable Assets:

FDA Letter
Bassinets

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