Increasingly, devices are becoming part of standard medical care The industry has formed the Medical Device Innovation Consortium (MDIC), dedicated to improving regulatory science and removing barriers to device development
Drug/device combination products are more common US regulators now require electronic copies of device submissions, a step away from paper-based practices
The Unique Device Identifier, or UDI, is an identifier that must appear on every post-approval device. It is mandatory for manufacturers and is changing the way healthcare organizations are managing devices
CDISC is playing a role in these changes. In early December, Dr. Rebecca Kush represented CDISC at a meeting hosted by the Pew Charitable Trusts that explored how the UDI could provide benefits to healthcare providers, consumers and others. Some of the other organizations that were represented included CDRH (FDA’s devices center), HL7, HHS/Office of the National Coordinator (ONC), American Hospital Association, Mayo Clinic, and others from healthcare, insurance, government and NGOs. Dr. Kush emphasized that research is an integral part of a learning healthcare environment, that CDISC standards are positioned to help and that the UDI has already been designed into the CDISC Device standards. Also, during this meeting, two investigators (from Harvard and Mercy Hospital) stated that safety reporting using EHRs ‘worked,’ referring to the ASTER and ASTER-D studies - 2 pilots testing the use of the CDISC-inspired IHE integration profile (Retrieve Form for Data Capture) in expedited adverse event reporting. In addition, how to move these successes forward was discussed. We intend to continue to participate in the projects that are resulting from this meeting.
Internal to CDISC, the device domains are also proving to be very useful to the Therapeutic Area development teams. Although the TA User Guides do not generally cover device trials, virtually every User Guide to date has included device domains for capturing device settings and other information as part of studying diseases. What will help even further are the CDASH and ADaM extensions that are being developed for the device domains.
While it’s very clear that the device world is varied and complex, the device standards development within CDISC and CDISC’s participation in non-profit, government and other initiatives are influencing the landscape towards greater awareness of the value of standards for clinical research. Hopefully, the coming year will see the next version of the CDISC Medical Device Implementation Guide, a more formal relationship between CDISC and FDA/CDRH, and continued CDISC representation on external initiatives that can improve the use of standards in medical device research.
By Kit Howard, CDISC Education Director
Strength through Collaboration
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44