5.10-1Principles Use of each Safety Device must be reviewed individually according to the process set out in this regulation. The purpose of the Safety Device, the impact its use has upon the person for whom it is prescribed or recommended, and the degree of intrusiveness the device imposes must be determined on an individual basis. Safety Devices that impose a greater degree of intrusiveness upon the person and have a greater impact upon the mobility of the person or the comfort of the person warrant a higher degree of scrutiny and oversight. Any Safety Device must impose the least possible restriction consistent with the purpose of insuring safety. Safety Devices may never be used as punishment, for staff convenience, or as a substitute for teaching the person new skills or abilities that would eliminate the underlying risk that gives rise to the request for the use of the device.
Review of the use of a Safety Device pursuant to this rule does not require a finding of a Challenging Behavior.
Except as provided in Section 5.10-7, a Safety Device may not have as its purpose, in whole or in part, the provision of Behavior Management.
5.10-2Specific Examples of Devices Usually Considered to be Safety Devices: The following is a list of devices or protective garb that could be considered to be Safety Devices:
A. A one-piece suit to prevent the person from pulling out an ostomy bag or interfering with similar medically necessary procedures, equipment, or apparel;B. A locked cupboard or locked refrigerator when the locking is implemented for the purpose of keeping a person with uncontrollable eating impulses from dangerous eating habits. This procedure must be supported by a medical diagnosis of a related disability, such as pica or Prader-Willi syndrome;C. Hand splints or gloves when used to prevent pica behavior or as a medically necessary intervention;D. A seat belt on a wheelchair when used to prevent the person from falling out of the wheelchair;E. A seat belt on a wheelchair when used to prevent the person from getting out of the wheelchair because the person has a history of falling or being unsteady;F. A seat belt on a toilet when used to prevent the person from getting off the toilet when the person has a history of falling off the toilet or getting off the toilet and being unsteady;G. Foot straps on a wheelchair when used to prevent the person's feet from dragging or getting caught;H. A diver's belt in a bathtub when used to prevent the person from floating while being bathed;I. A chest strap while on the toilet when used to prevent the person from falling off the toilet;J. A belt on a chair, including a shower chair or a Hoyer lift, when used to keep the person from falling or slipping out of the chair or lift;K. Any bed rail that substantially inhibits the person from rising off of or getting out of the bed when the person has a history of unintentionally falling;L. A gait belt for a person, when used to assist the person with walking or transfers and the person has a history of unsteadiness or falls;M. A helmet used solely for safety purposes, for instance to protect a person who has a history of falling because of seizures. See also Section 5.10-7;N. Monitoring devices that do not limit the Person's movement when used to monitor the movement of a Person due to lack of environmental awareness or history of unintentional falling. Examples of these devices include a sound monitor that picks up sounds in the vicinity of the person and transmits those sounds to staff, a chair alarm, a bed alarm, an ankle bracelet, a door alarm or light (including infrared light). Non-exclusivity of the Lists of Devices Above: The devices listed above are not intended to describe every Safety Device that might be used or devised. Planning Teams and qualified professionals may suggest other Safety Devices and those Safety Devices may be utilized if they meet the definition of a Safety Device under state law and this regulation. Review Teams may use the lists above as guidance in judging by analogy whether the purpose and use of any proposed device qualifies the device as a Safety Device as defined above.
5.10-3Review ProcessA.Preliminary Requirements Prior to Review1. Any use of a Safety Device must be pursuant to a written recommendation from a physician qualified to practice in the state of Maine.2. Any use of a Safety Device must be approved by the Person's Planning Team, and that approval must be recorded in a document that is part of the Person's planning record. Any member of the Planning Team may request review or involvement by an Advocate.3. If the person has a guardian, or if the person is under limited medical guardianship, the guardian must approve the use of the Safety Device. If the person does not have a guardian, the person must consent to the use of the Safety Device.4. When a Person has a Safety Device that may impact other Persons residing in the home or participating in the program by restricting their Rights, accommodations must be identified and implemented to minimize the impact on the other Persons. The Personal Plan of each Person affected by the use of the Safety Device must indicate how that Person will be supported to minimize the negative impact of any restriction.5. When a video monitoring device or video recording is used and it is highly predictable that another Person will trigger or appear on the monitoring or recording device, the consent of that Person must be obtained.B.Frequency of Review Any use of a Safety Device must be reviewed at least once per year by the Review Team. Any preliminary requirements for review, as set out in Section 5.10-3(A), must be renewed each year prior to reapproval by the Review Team. Any member of the Review Team may require that use of a Safety Device be reviewed more frequently. If review takes place more frequently than annually, any consent, approval, or recommendation that is a preliminary requirement for review must be current at the time of the review.
C.Standard Forms All initial and renewal requests for permission to use a Safety Device must be submitted on a standard form made available by the Department. Each request for permission must be accompanied by the written recommendation of a physician, and any required consents for the use of the Safety Device. The request form must clearly identify the Safety Device and must describe the conditions of use of the device and the anticipated frequency of its use. The request form must include a place for the Review Team to indicate approval or disapproval of the Safety Device and must include a mailing address and fax number to which the approval can be sent.
D.Requests for Multiple Safety Devices for the same person Each request for permission to use a Safety Device must have its own professional authorization that refers specifically to that Safety Device. Any consent and Planning Team approval required to use a Safety Device must refer specifically to the Safety Device for which the consent or approval is being given. Safety Devices that are normally used in pairs, such as gloves or foot straps, do not need separate requests.
E.Review Team Practices For Safety DevicesThe approval of a Safety Device requires both voting members to vote in favor of the plan or the plan with conditions. The Review Team may require additional information prior to approval of a Safety Device.
F.Time for DecisionThe Review Team shall make a determination of approval or disapproval within thirty (30) calendar days of its receipt of the request for approval and all completed supporting or accompanying documentation necessary to conduct the review.
G.Notifications after Review The person or entity requesting approval to use a Safety Device is responsible for notifying the Person's Planning Team of the decision made by the Review Team. The Planning Team may designate a member of the team to receive this notification.
5.10-4Use of Safety Related Devices or Practices that Do Not Need Approval of the Review Team The following safety related devices or practices are not uses of Safety devices for the purpose of this rule and therefore are not subject to the above requirements in these regulations.
A. The routine use of seat belts in a vehicle;B. Use of tie downs in a van to prevent a person in a wheelchair from flipping over;C. The practice of having vehicle doors locked while the vehicle is moving, when applied by written agency policy to all persons transported in a vehicle;D. A doctor's order that a Person be held temporarily or that a device such as a strap be used to temporarily restrain a Person so that a medical procedure (such as the drawing of blood from the Person) can occur. A written doctor's order for the physical restraint or for the device is necessary as part of or as an adjunct to the order for the medical procedure that is being performed.E. A doctor's order that a Person be held temporarily or that a device be used temporarily to restrain a Person's movement due to a change in medical condition in order to feed the person, or for the routine administration of medication, or for aiding the Person's performance of activities of daily living skills. Any such order may be applied only in the circumstances prescribed in the written order by the doctor. Any such order for a temporary restraint must have the consent of the guardian if the Person is under guardianship, or the consent of the Person if the Person is not under guardianship.F. A doctor's standing order for the holding of a Person or the use of a device that restrains a Person's movement in order to feed the Person, or for the routine administration of medication, or for aiding the Person's performance of activities of daily living skills. Any such standing doctor's order must be approved by the Person's Planning Team, and must have the consent of the guardian if the Person is under guardianship, or the consent of the Person if the Person is not under guardianship.G. Use of any device that is a Therapeutic Device.5.10-5Requirements for the Use of a Therapeutic DeviceA. Any therapeutic device may only be applied under the supervision of a medical doctor, occupational therapist, or physical therapist licensed to practice in the state of Maine. The professional may delegate responsibility for the day-to-day application of the use or application of the support to others, as long as any other persons applying the support have been trained in the proper use of the support and the professional retains professional responsibility for the application of the support.B. The use and design of any Therapeutic Device must be individualized to the specific need of the person who is using the support, so as to meet the need and maximize the comfort of the person.C. Any Therapeutic Device must make allowance for the person to change body position.D. The impact upon the person's body alignment and blood circulation must be considered in the use of any Therapeutic Device.5.10-6Distinctions Between Safety Devices, Devices that are Utilized for Behavioral Management, and Therapeutic Devices.When the same device or apparatus meets the definition of a Therapeutic Device, a device for behavioral management, or a Safety Device the Person's Planning Team should initially render a classification. Notwithstanding this initial classification, the Review Team may exercise its own discretion in classifying any device, intervention, or practice.
5.10-7Helmets Used to Prevent or Diminish the Degree of Injury to a Person Engaging in Self Injurious Behavior A helmet whose primary purpose is to protect a Person from self-injurious behavior or to diminish the degree of injury of a person engaged in self-injurious behavior, or whose purpose is to prevent a person from biting others, is presumed to be part of a Level 3 Behavior Management Plan for the first year of its use. The use of the helmet during that year is subject to the requirements for review under Section 5.10-3. A Review Team may exercise its discretion to classify the use of a helmet for the purposes enumerated in this paragraph as a Safety Device if after the expiration of the first year of the device's use it concludes that the primary purpose of the use of the helmet is as a Safety Device and that review of the use of the helmet as behavior intervention is no longer necessary.
5.10-8Use of Monitoring Devices for SafetyMonitoring devices must only be considered after less intrusive techniques have been tried and failed. Motion detectors, sound monitoring, and video monitoring devices must be supported by a history of a lack of environmental awareness and/or a related medical diagnosis, such as Dementia.
Every effort must be made to maintain privacy and confidentiality in the use of these devices. The plan must include procedures used to maximize privacy and maintain confidentiality.
14-197 C.M.R. ch. 5, § 10