DDES Memo Series
2005-08
June 20, 2005
STATE OF WISCONSIN
Department of Health and Family Services
Division of Disability and Elder Services
To:
Area Administrators/Human Services Area Coordinators
Bureau Directors
County Departments of Community Programs Directors
County Departments of Developmental Disabilities Services Directors
County Departments of Human Services Directors
County Departments of Social Services Directors
Section Chiefs
Tribal Chairpersons/Human Services Facilitators
From:
Burnie Bridge, Division of Children and Family Services
Administrator
Mark Moody, Division of Health Care Financing
Administrator
Sinikka Santala, Division of Disability and Elder Services
Administrator
Re: Use of Vail Beds for Children and Adults with Developmental
Disabilities
Attached to his memo are materials related to a recent announcement of
the U.S. Food and Drug Administration (FDA) related to concerns regarding
the use of beds manufactured by Vail Products, Inc., located in Toledo,
Ohio. The announcement relates to the Vail 500, 1000, and 2000 Enclosed
Bed Systems. The FDA has determined that the use of these beds poses a
public health risk because patients can become entrapped and suffocate,
resulting in severe neurological damage or death. The FDA is aware of
approximately 30 entrapments resulting from use of these beds, resulting
in at least seven (7) deaths. The FDA has advised consumers to stop using
these bed systems. If continued use is the only option, Vail Products
recommends users follow certain safety precautions.
The FDA has ordered the U.S. Marshall's Service to seize unsold stocks
of these beds. DDES and DHCF have already taken action to stop MA card and
waiver payments for these devices. However, we are aware that some
individuals who are served by counties or are under DHS
guardianship
continue to be restrained in Vail beds in both licensed facilities and in
private homes.
All county and Department approvals of these beds pursuant to s. HFS
94.10, Adm. Code, must be re-reviewed in light of the FDA findings and
action. As to continued use, we are alerting interested parties to this
federal action and will monitor the situation. All proper care and
attention should be paid to the concerns raised by the FDA. All county and
Department approvals must include the required safety measures.
It is critical, and it is our expectation, that agency directors
disseminate this information to supervisors and direct service
caseworkers.
We will provide additional information as any further actions are
taken.
REGIONAL OFFICE CONTACT:
Area Administrator
MEMO WEB SITE:
http://www.dhs.wisconsin.gov/partners/local.htm
Attachments:
FDA Preliminary Public Health Notification:
Vail Products
Enclosed Bed Systems
c:
Bureau of Quality Assurance
County Foster Care Coordinators
Directors, Adult Licensed Facilities
Directors, Group Foster Homes for Children
Directors, Licensed Child Care Centers
Directors, Private Child Placing Agencies
Directors, Residential Care Centers for Children and Youth
Directors, Shelter Care Facilities
President, WI Foster and Adoptive Parents Association
Wisconsin Association of Family and Children's Agencies
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