Due to the COVID-19 public health emergency, there may be an increased demand for hospital beds, stretchers, and mattresses to expand health care capacity in local hospitals, and health care systems through temporary expansion sites. To meet this need, manufacturers from a variety of industry sectors not traditionally associated with medical device manufacturing are looking for resources to manufacture and market these devices to the healthcare community. This document is intended to address questions related to the design, evaluation, labeling, and marketing of hospital beds, stretchers, and mattresses during the COVID-19 public health emergency.
Q: How can I know in advance whether manufacturers will have a shortage of hospital beds, stretchers, or mattresses so I can prepare?
A: The FDA is aware that as the COVID-19 public health emergency continues, the supply of hospital beds, stretchers, or mattresses, may become limited. We are continuing to monitor the situation and are working to mitigate potential shortages. For questions about shortages, please see Contacts for Medical Devices During the COVID-19 Pandemic.
Q: How does the FDA regulate hospital beds, stretchers, and mattresses?
A: There are multiple regulations and product codes for hospital beds, stretchers, and mattresses that describe the FDA regulatory requirements applicable to each. The product description, technology, method of operation, and intended use will generally determine which product code and regulation the device may fall under. Below is a list of the existing hospital bed, stretcher, and mattress product codes and regulations that can be referenced on the FDA's Product Classification Database.
|Product Code||21 CFR Section||Classification Name||Device
|FNL||880.51||AC-powered adjustable hospital bed||II||Yes|
|OSI||880.5100||AC-powered adjustable hospital bed, bariatric||II||Yes|
|LLI||880.51||AC-powered adjustable hospital bed, home-use||II||Yes|
|FNM||880.56||Alternating pressure air flotation mattress||II||Yes|
|FNK||880.51||Hydraulic adjustable hospital bed||I||Yes|
|FNJ||880.51||Manual adjustable hospital bed||I||Yes|
|INY||890.52||Manual patient rotation bed||I||Yes|
|FMR||880.68||Manual patient transfer device||I||Yes|
|FMW||880.62||Mattress cover for medical purposes||I||Yes|
|KME||880.61||Medical disposable bedding||I||Yes|
|IKY||880.52||Nonpowered flotation therapy mattress||I||Yes|
|FMS||880.51||Pediatric medical crib||II||Yes|
|IOQ||890.52||Powered flotation therapy||II||Yes|
|MOC||890.52||Powered flotation therapy bed||II||Yes|
|IKZ||890.52||Powered patient rotation bed||II||Yes|
|ILK||890.52||Powered patient transport||II||No*|
|INK||890.37||Powered wheeled stretcher||II||No*|
|FOH||880.56||Temperature regulated water mattress||I||Yes|
*The FDA reviews premarket notifications (510(k)s for powered transports and powered stretchers). The FDA also oversees manufacturing, labeling and postmarket surveillance for medical devices that require premarket review, including submissions under 510(k) and those that are 510(k)-exempt.
Q: We are considering manufacturing hospital beds. What recognized consensus standards are applicable for evaluating hospital beds?
A: The FDA recognized consensus standards that may be applicable are:
- 6-321 IEC 60601-2-52 Edition 1.0 2009-12
Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)]
- 6-390 IEC 80601-2-35 Edition 2.1 2016-04
CONSOLIDATED VERSION Medical electrical equipment-Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use [Including: Amendment 1 (2016)]
Q: Is there an FDA guidance document for hospital beds, stretchers, and mattresses?
Manufacturers may refer to the FDA guidance document, Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment, for recommendations on designing new beds to help ensure compliance with applicable FDA regulations, to provide adequate labeling and instructions for use, and to assist in ensuring that their devices are safe when used as labeled. Stretchers not used for extended-stay, examination tables, operating room tables, radiology tables, proning tables, exercise and range of motion tables, bathing units, and mechanical lifting devices are excluded from the scope of this guidance because they are not ordinarily used as hospital beds.
For surfaces intended to contact skin or tissue, please refer to the FDA guidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", which describes the use of International Standard ISO 10993-1 to support premarket submissions to the FDA and provides recommendations on biocompatibility testing.
Q: Our products have antimicrobial or antiviral properties. Can we promote these claims in our labeling and advertising material?
A: The FDA is not aware of any currently legally marketed hospital beds, stretchers, or mattresses with antimicrobial or antiviral claims. If you are interested in marketing your device with antimicrobial or antiviral properties, please contact the FDA as described in the guidance document, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.
Q: What are the requirements regarding new and non-traditional supply chain partners? These supply chain partners potentially include a wide variety of industry sectors such as the sewing, furniture, automotive, aerospace, machine shop, and steel manufacturing industry sectors. Does the FDA have concerns regarding suppliers that are not familiar or complaint with 21 CFR Part 820 regulations?
A: Raw material suppliers are not required to register their establishments and list their products with the FDA or to comply with Quality System Regulations in 21 CFR Part 820. The original equipment manufacturer (OEM) is responsible to ensure the use of appropriate materials and qualified suppliers, and that the manufacture of these devices is compliant with 21 CFR Part 820.
Q: What if I have additional questions about how to legally market a hospital bed, stretcher, or mattress during the COVID-19 public health emergency?
A: If you have questions, please email the FDA's Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov or call 800-638-2041 or 301-796-7100.
Q: How do we report shortages of hospital beds, stretchers, or mattresses?
A: The FDA encourages users and facilities who are concerned about distribution of a medical product, or anticipate a potential or actual shortage, to notify the FDA. For potential or actual supply issues, email information to the FDA at email@example.com.
Device manufacturers that are required to notify FDA of an interruption or permanent discontinuance in manufacturing during the COVID-19 public health emergency should submit their notifications via email to CDRHManufacturerShortage@fda.hhs.gov . Please begin the email subject line with the word "Notification."
On May 6, 2020, the FDA published an immediate in effect guidance to assist manufacturers in providing the FDA with timely and informative notifications about changes in the production of certain medical device products that will help FDA prevent or mitigate shortages of such devices during the COVID-19 public health emergency.