DRAFT MTRs HOSPITAL BEDS.docx

The Veterans Health Administration (VHA), Prosthetic & Sensory Aids Service (PSAS) has a need for Hospital Beds for Home Use w/Accessories. Hospital Beds for Home Use are electric beds used for community care/home and is designed for disable and elderly individuals who are being cared for outside of hospital. The Integrated Product Team (IPT) has developed a new set of Minimum Technical Requirements (MTRs) with the purpose of providing added flexibility for VA clinicians to support Veterans and their specific needs.

Minimum Technical Requirement (MTR) for the Hospital Beds for In Home Use.

Attached is a draft of the MTRs for the requirement of the Hospital Beds for In Home Use. The VA is soliciting suggestions, recommendations and comments on the MTRs and the HCPSs associated with the MTRs. Any information provided is greatly appreciated in helping with creating a proposal that will benefit the needs of the Veteran. Please submit your comments to Zachary.Wilcox@va.gov, Darrell.Williamson@va.gov and Jessica.Abrams@va.gov. All comments will need to be submitted by November 15, 2024, 1400EST.

Product Identification and Minimum Technical Requirements (MTR’s) Beds for Home Issuance

Hospital Beds for Home Use is an electric bed used for community care and is designed for disabled and elderly individuals who are being cared for outside of hospital.

Bed must meet the IEC standard 60601-1-11 Edition 1.0:2010 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare. Also, IEC standard 60601-2-52, Medical electrical equipment – Part 2-52: Requirements for the basic safety and essential performance of medical beds. Edition 1.0, 2009-12.

Key Elements of IEC 60601-2-52 Bed Standard

1. Changes in the gaps and clearances of side rails which have been calculated looking at percentile adult male and female head, neck and chest dimensions.

1. The side-rails must with-hold a high force of 250N between the bars along with the lower bar and the bed frame (previously 30N).

1. Bed user manuals must specify the mattress size to reduce the risk of a patient becoming entrapped between the mattress and side rail.

1. Locking mechanism on the side rails to be more robust and with stand a 30,000-cycle test (up and down).

1. Both the safe working load (SWL) and maximum patient weight must be visible on the bed

Description of Electric Hospital Bed: A bed having side rails that can be raised or lowered; and a support surface (mattress) base in jointed sections so that the bed deck, head, and foot sections, may be raised by a motor, allowing a patient to lie in various positions, as a therapeutic aid while maximizing comfort to promote rest and sleep hygiene.

Description of Pressure Re-Distribution Support Surface: Fabricated from materials for maximum pressure re-distribution that is designed to be placed directly on the existing bed frame. e.g., foam, gel, low air loss, alternating pressure, etc.

Description of Bed Side Rails: Safety devices used to reduce the risk of patients accidentally slipping, sliding, or rolling out of bed. These can be full or split and are positioned along the sides of a bed. They are attached to frame of the bed and raise/lower as the bed is raised and lowered. The rails also raise/lower for entry/egress when the bed is stationary. The rails must interface with the head/foot board to ensure there is not risk of entrapment between the rails, bed, head/footboards. The rails should allow for secure attachment to the bed frame for aiding in turning and repositioning within the bed, providing a handhold for getting into or out of bed, and providing a feeling of comfort and security (https://www.fda.gov/medical-devices/hospital-beds/guide-bed-safety-bed-rails-hospitals-nursing-homes-and-home-health-care-facts).

Description of Trapeze Bar: An item designed for use in the raising and lowering of the body without assistance; may consist of bed mounting screw, chain, and handgrip.

Description of Static Mattress: non-powered and can be made of multilayered foam, gel, or combination.

Description of Dynamic and/or Convertible Mattress: powered pressure reducing air mattress with pump.

Basic Electric Bed Frame Model should be made available meeting 80” x 36” that does not require adjustable capability (no mattress) E0266 E0303 (Extra wide)

Suggestions 1

Suggestions 2

Electric controls for head and foot sections both elevate independently as well as simultaneous movement of head and foot sections to reduce shearing. Electric control for the bed deck raises and lowers independently to allow for overall raising and lowering of bed height. Must be capable of these functions regardless of which type of rails are on the bed (i.e., full, half, or split rails) with rails in locked and upright position or with rails in down position.

N/A

Suggestions 3

Must provide patient control pendent that is fluid (liquid) resistant and controls all the electrical movements of the bed. Pendant must have back lighting, raised buttons, and attachment components for bed rail or clothing.

N/A

Suggestions 4

Must have head and foot boards.

N/A

Suggestions 5

Bed must be able to accept full rails or a combination of either split or half rails.

E0310 Full E0305 Split

Suggestions 6

Pressure Redistribution Mattress (multi-layered foam, gel, air, or any combination thereof). Must be moisture resistant. Minimum sleep surface of 36” x 80” inches. Mattress must follow all federal and state fire codes and regulations and must be clearly marked with industry standard labeling.

E0184 Dry E0186 Air E0185 Gel (E0373 Non power)

Suggestions 7

Pressure Redistribution Mattress (multi-layered foam, gel, air, or any combination thereof). Must be moisture resistant. Minimum sleep surface of 42” x 80” inches. Mattress must follow all federal and state fire codes and regulations and must be clearly marked with industry standard labeling.

Suggestions 8

Pressure Redistribution Mattress (multi-layered foam, gel, air, or any combination thereof). Must be moisture resistant. Minimum sleep surface of 36” x 84” inches which can be accomplished with a static and/or dynamic, one-piece mattress or bolsters. Mattress must follow all federal and state fire codes and regulations and must be clearly marked with industry standard labeling.

Suggestions 9

Pressure Redistribution Mattress (multi-layered foam, gel, air, or any combination thereof). Must be moisture resistant. Minimum sleep surface of 42” x 84” inches which can be accomplished with a static and/or dynamic, one-piece mattress or bolsters. Mattress must follow all federal and state fire codes and regulations and must be clearly marked with industry standard labeling.

Suggestions 10

N/A

Suggestions 11

Suggestions 12

Suggestions 13

For head control, foot control, and elevation control must be replaceable.

N/A

Suggestions 14

Must be a 3 prong (grounded plug. NOTE: Veterans with only two-pronged outlets will require an electrician to update the electrical outlet or an off contract bed would need to be procured.

N/A

Suggestions 15

All motors that control the power motor functions of the bed must have a battery back-up in the event of power outage. The battery back-up must be sufficient to raise and lower the head and foot sections as well as to raise and lower the bed deck to allow for overall raising and lowering of bed height. Battery Back Up feature must be able to perform all motor functions.

N/A

Suggestions 16

Bed must have a mount which supports/accepts the overhead trapeze accessory N/A

Suggestions 17

E0911 (Heavy Duty)

Suggestions 18

Suggestions 19

Four total wheels – either two wheels with two locking casters or four wheels with four locking casters.

N/A

Suggestions 20

Suggestions 21

When the bed is raised or lowered, there is no pinch point that can damage electrical power or pendent cords.

N/A

Suggestions 22

Suggestions 23

Bed/Frame: Minimum of 10 years.

Power System/Electrical components: Minimum of 3 years.

Mattress: Minimum of 3 years.

Accessories: Minimum of 1 year.

N/A

Suggestions 24

Website and customer service telephone line with live operator for technical support. Service telephone line should be available during normal business hours, Monday - Friday, and clearly stated on company website.

N/A

Suggestions 25

Additional Suggestions for MTRs and HCPCs.

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