Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank

Journal Healthcare
Authors Terrie L. Reed, Joseph P. Drozda Jr., Kevin M. Baskinc, James Tcheng, Karen Conway, Natalia Wilson, Danica Marinac-Dabic, Theodore Heise, Mitchell W. Krucoff
Year Published 2016
Link to publication

Abstract

The Medical Device Epidemiology Network (MDEpiNet) is a public private partnership (PPP) that provides a platform for collaboration on medical device evaluation and depth of expertise for supporting pilots to capture, exchange and use device information for improving device safety and protecting public health. The MDEpiNet SMART Think Tank, held in February, 2013, sought to engage expert stakeholders who were committed to improving the capture of device data, including Unique Device Identification (UDI), in key electronic health information. Prior to the Think Tank there was limited collaboration among stakeholders beyond a few single health care organizations engaged in electronic capture and exchange of device data. The Think Tank resulted in what has become two sustainable multi-stakeholder device data capture initiatives, BUILD and VANGUARD. These initiatives continue to mature within the MDEpiNet PPP structure and are well aligned with the goals outlined in recent FDA-initiated National Medical Device Planning Board and Medical Device Registry Task Force white papers as well as the vision for the National Evaluation System for health Technology.

You’re invited to join the AHRMM Learning UDI Community High Risk Implant Work Group!

This Work Group is tasked with:

·         Defining criteria that identify high risk implants

·         Developing an API to be used to query the GUDID for the items that meet this criteria

The work of this group ties directly to the X12 proposal to include Device Identifiers (DI) in the claims forms and comments to the FDA recommending a more refined list of high risk implants whose DI would be included in claims, as opposed to all items/all DIs.

The LUC High Risk Implant Work Group Charter can be found at: http://www.ahrmm.org/resources/learning-udi-community/pdfs/work-groups/high-risk-criteria-implants-work-group-summary-statement-103116.pdf.

Please contact AHRMM (ahrmm@aha.org) with questions or if you are interested in joining this important Working Group or visit the Learning UDI Community website at: http://www.ahrmm.org/resources/learning-udi-community/index.shtml for information about other LUC Working Groups.

Invitation to join the AHRMM Learning UDI Community (LUC) Device Categorization Working Group

Please consider this invitation to join a new Association for Healthcare Resource & Materials Management (AHRMM) Learning UDI Community Working Group that will focus on Device Categorization—specifically, the analysis & evaluation of GMDN/SNOMED for PAD devices.

This LUC Working Group will provide an opportunity for you to finish what was raised as an issue during RAPID Phase I and take the work back to RAPID in Phase II/III. It is also an opportunity for you to set the foundation for device categorization work in other areas—hopefully by generalizing the findings to apply to other categories of medical devices.

The LUC Device Categorization WG Charter can be found at: http://www.ahrmm.org/resources/learning-udi-community/pdfs/work-groups/device-categorization-work-group-summary-statement-103116.pdf.

Please contact AHRMM (ahrmm@aha.org) with questions or if you are interested in joining this important Working Group or visit http://www.ahrmm.org/resources/learning-udi-community for information about other LUC Working Groups.

Registry-Based Prospective, Active Surveillance of Medical-Device Safety

Journal New England Journal of Medicine (NEJM)
Authors Frederic S. Resnic, M.D., Arjun Majithia, M.D., Danica Marinac-Dabic, M.D., Ph.D., Susan Robbins, B.S., Henry Ssemaganda, M.D., Kathleen Hewitt, M.S.N., Angelo Ponirakis, Ph.D., Nilsa Loyo-Berrios, Ph.D., Issam Moussa, M.D., Joseph Drozda, M.D., Sharon-Lise Normand, Ph.D., and Michael E. Matheny, M.D., M.P.H.
Year Published 2017
Link to publication

Abstract

Background

The process of assuring the safety of medical devices is constrained by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of an implantable vascular-closure device that had a suspected association with increased adverse events after percutaneous coronary intervention (PCI).

Methods

We used an integrated clinical-data surveillance system to conduct a prospective, propensity-matched analysis of the safety of the Mynx vascular-closure device, as compared with alternative approved vascular-closure devices, with data from the CathPCI Registry of the National Cardiovascular Data Registry. The primary outcome was any vascular complication, which was a composite of access-site bleeding, access-site hematoma, retroperitoneal bleeding, or any vascular complication requiring intervention. Secondary safety end points were access-site bleeding requiring treatment and postprocedural blood transfusion.

Results

We analyzed data from 73,124 patients who had received Mynx devices after PCI procedures with femoral access from January 1, 2011, to September 30, 2013. The Mynx device was associated with a significantly greater risk of any vascular complication than were alternative vascular-closure devices (absolute risk, 1.2% vs. 0.8%; relative risk, 1.59; 95% confidence interval [CI], 1.42 to 1.78; P<0.001); there was also a significantly greater risk of access-site bleeding (absolute risk, 0.4% vs. 0.3%; relative risk, 1.34; 95% CI, 1.10 to 1.62; P=0.001) and transfusion (absolute risk, 1.8% vs. 1.5%; relative risk, 1.23; 95% CI, 1.13 to 1.34; P<0.001). The initial alerts occurred within the first 12 months of monitoring. Relative risks were greater in three prespecified high-risk subgroups: patients with diabetes, those 70 years of age or older, and women. All safety alerts were confirmed in an independent sample of 48,992 patients from April 1, 2014, to September 30, 2015.

Conclusions

A strategy of prospective, active surveillance of a clinical registry rapidly identified potential safety signals among recipients of an implantable vascular-closure device, with initial alerts occurring within the first 12 months of monitoring. (Funded by the Food and Drug Administration and others.)

 

Long-term Postprocedural Outcomes of Palliative Emergency Stenting vs Stoma in Malignant Large-Bowel Obstruction

Journal JAMA Surgery
Authors Abelson JS, Yeo HL, Mao J, Milsom JW, Sedrakyan A.
Year Published 2017
Link to publication

Abstract

This study investigated readmission, reoperation, and other outcomes following palliative stent or stoma operation for bowel obstruction due to colorectal cancer in New York State, both in-hospital and long-term (90 days and 1 year). It was found that patients living closer to high-volume centers were more likely to undergo a stenting procedure. Patients who underwent stenting had lower rates of in-hospital death and of procedural complications than those who underwent stoma creation. Patients who received stents also had a shorter average length of stay and were less likely to be discharged to a nursing or rehabilitation facility. However, patients undergoing stenting were more likely to receive another procedure in the following year, mostly a re-stenting procedure. Stenting is safe in patients who are to receive only palliative treatment for bowel obstruction when offered at high volume hospitals. Patients should be cautioned that they might receive another stenting in the following year.