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ODP

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The Office of Developmental Programs (ODP) has shared this important announcement from the U.S. Food and Drug Administration (FDA) about the recall of Defibtech, LLC, RMU-2000 ARM XR Chest Compression Devices due to a problem with the device’s motor that may cause it to stop compressions. The use of the affected product may cause serious adverse health consequences, including:

  • Patient injuries;
  • Delay of therapy; and
  • Death due to a period of time without compressions to circulate oxygen throughout the body.

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.

Affected Product

  • RMU-2000 Chest Compression Module
    • Product Name: RMU-2000 ARM XR Chest Compression Device
    • Unique Device Identifier (UDI)/: UDI-DI: 00815098020812, 10815098020819
    • Serial Numbers: See full list.

What to Do

Do not use affected Defibtech RMU-2000 ARM XR Chest Compression Devices (identified by serial numbers). On July 12, 2024, Defibtech, LLC, sent all affected customers an Urgent Medical Device Safety Removal letter recommending the following actions:

  • Identify and quarantine affected units; and
  • If devices were transferred or distributed further, please ensure the recipients are aware of this notice or provide Defibtech with contact information.

Customers will be contacted by Defibtech to arrange for product return and devices will be refunded, repaired, or replaced at no cost.

Reason for Recall

Defibtech, LLC, is recalling RMU-2000 ARM XR Chest Compression Devices due to a problem with the device’s motor that may cause it to stop compressions.

The use of affected product may cause serious adverse health consequences, including patient injuries, delay of therapy and death due to a period of time without compressions to circulate oxygen throughout the body. There has been one reported injury and one report of death.

Device Use

The RMU-2000 ARM XR Chest Compression Device is used to provide chest compressions on adults whose hearts suddenly stop and are not circulating blood throughout the body.

Contact Information

Customers in the US with questions about this recall should contact Defibtech Customer Support at 877-453-4507, 7:30 am – 6:00 pm EST.

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The Office of Developmental Programs (ODP) has shared ODPANN 24-080. This communication announces that Temple University Harrisburg’s Certified Investigator (CI) Program and ODP will be facilitating forums for certified investigators and others involved in the incident investigation process. It also announces the posting of Q&A documents from past CI Forums on MyODP. Please view the announcement for registration information and details.

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The Office of Developmental Programs (ODP) has published ODPANN 24-078, which is a resource that has been developed from questions submitted to the Performance-Based Contracting (PBC) Resource Account. Questions have been categorized by topic and performance measures.

The FAQ can be accessed at Performance-Based Contracting FAQs – MyODP. ODP will continue to update this site with answers to recurring questions that are sent to the RA account.

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Charting the LifeCourse was created to help individuals and families of all abilities and ages to develop a vision for a good life, think about what they need to know and do, identify how to find or develop supports, and discover what it takes to live the lives they want to live. These standalone training sessions are for all professional stakeholders. Each session will cover the same content.

Participants in this training will:

  • Learn about the National Charting the LifeCourse Community of Practice;
  • Apply LifeCourse principles and the LifeCourse framework; and
  • Practice using LifeCourse tools.

Register Here for trainings.

Dates:

  • September 27, 2024, 9:00 am – 1:00 pm
    Registration on MyODP opens at 8:00 am on 8/16/2024.
  • December 11, 2024, 11:00 am – 3:00 pm
    Registration on MyODP opens at 8:00 am on 10/30/2024.
  • February 28, 2025, 9:00 am – 1:00 pm
    Registration on MyODP opens at 8:00 am on 1/17/2025.
  • April 10, 2025, 11:00 am – 3:00 pm
    Registration on MyODP opens at 8:00 am on 4/8/2025.

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Checklist concept - checklist, paper and pen

The Office of Developmental Programs (ODP) has shared a new tool designed to support Administrative Entities and ODP staff when Providers or Supports Coordination Organizations (SCO) choose to provide agency-developed or agency-identified training that meets the General Orientation and annual training requirements of the 55 PA Code 6100. The reviewer determines if the identified staff completed each required annual training core course based on provider training records, including, but not limited to, a description of the course, sign-in sheets, transcripts, or certificates of completion from the training. ODPANN 24-036 is being included as a reminder of the annual training requirements.

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assistance, support, guidance - business concept words in color hexagons over blue background, flat design

The Office of Developmental Programs (ODP) is thrilled to announce this updated guide, packed with valuable information to support you in navigating EVV requirements effectively.

What’s New in the Version 3.0:

  • Clearer Guidance: ODP has improved the guide’s readability so you can locate the information you need more quickly.
  • Improved Review: Version 3.0 ensures you are up-to-date with rules by providing a complete overview of the most recent EVV requirements.
  • Enhanced Accessibility: To better serve a wide range of users, ODP improved accessibility features, making the guide easier to use for all.
  • Streamlined Processes: Based on your feedback, ODP streamlined processes to help you enhance your EVV implementation.

Reminder: Update Your Administration Information!

ODP noticed that many of their quarterly EVV Manual Edit Compliance reports are being returned due to bad addresses. To ensure you receive important updates and reports, please update your administration information in the Sandata Aggregator with your current email address. If you have any questions or need assistance with updating your information, please contact the Sandata EVV Customer Care Portal (Sandata On-Demand).

If you have any questions about the ODP Comprehensive Guide to EVV, please contact the ODP EVV inbox.

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ODP Bulletin ODPANN 24-015 provides guidance for implementing changes to Assistive Technology and Remote Supports in the amendments to the Consolidated, Community Living, Person/Family Directed Support (P/FDS), and Adult Autism Waivers. Please note that this communication is being reissued with an update to Attachment B only. The other attachments are being included for reference.

ATTACHMENTS:

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