AHRMM eNews Weekly Member Update
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AHRMM NEWS
Get to Know the AHRMM Board of Directors Candidates
 
Meet the candidates for the 2016 Election! For the term beginning on January 1, 2017, there are two healthcare provider seats open, and one affiliate seat open. Who gets elected is determined by those who participate!
 
Review the candidate profiles and personal flyers to make an informed decision when voting opens August 1.

Participate in the Duke University Supply Chain Management Survey
The U.S. Food and Drug Administration is standing up a national Coordinating Center focused on improving real-world evidence on medical devices. A Planning Board has been tasked with identifying how the Coordinating Center can meet the needs of various stakeholders, including the supply chain management community. The Board would like to hear from you.
 
Please take 10-15 minutes to participate in this survey on your medical device and supply chain management needs. A synopsis of the responses will be included in an upcoming Planning Board white paper, which will be made available to AHRMM members when it is released in August.
Take the Survey

AHRMM Congratulates New CMRPs
Congratulations to the following individuals for receiving their Certified Resource and Materials Management (CMRP) credential in May 2016:
  • Steven Waldron, Kalamazoo, MI
  • Gregory Inman, York, PA
  • Nathaniel Decker, San Antonio, TX
Invest in your career and get certified! Obtaining a CMRP designation is a great way to document your knowledge, skills, and experience.
 
You can receive instant results when you take your CMRP exam at AHRMM16. To help you better prepare for the exam, AHRMM is offering a CMRP Overview Session on Sunday morning, July 31.
 
CMRP exam applications are due July 1! Click here to review the exam schedule and application process.
INDUSTRY NEWS
Experimental Zika Vaccine Approved for Clinical Trials for First Time in US
On Monday, the Food and Drug Administration approved a clinical trial for an experimental vaccine for Zika virus. The first people could be injected within a few weeks, said Inovio President and CEO Dr. Joseph Kim. Inovio, of Plymouth Meeting, PA. GeneOne Life Science, of Seoul, South Korea, will make the vaccine. Interim results from the trial, which will involve 40 healthy adults, are expected later this year.
 
The National Institute of Allergy and Infectious Diseases is also designing its own DNA Zika vaccine. NIAID director Dr. Anthony Fauci said Monday that preliminary paperwork for this vaccine is already before the FDA and results from animal testing look promising.

 
 
Source: HPN Daily Update – June 21, 2016

CDC Issues Preparedness Plan for Locally Acquired Zika Cases
The Centers for Disease Control and Prevention last week issued an interim plan for responding to locally acquired cases of Zika virus infection in the continental U.S. and Hawaii. As of June 15, only travel-associated cases have been reported in the continental U.S., including three infants born with birth defects and three pregnancy losses in U.S. states. The response plan outlines state and CDC activities to prevent and reduce local transmission once it has been identified. According to CDC, Zika infections appear to be increasing rapidly in Puerto Rico, based on a 1.1% infection rate among local blood donations in the week ending June 11. The territory has screened all local blood donations for Zika since April using a highly accurate test. In areas without active Zika virus transmission, the Food and Drug Administration recommends deferring from blood donation people who have had Zika-like symptoms in the past four weeks; sexual contact with someone who has traveled to or lived in an area with active Zika virus transmission in the past three months; or traveled to areas with active transmission in the past four weeks.
 
Source: AHA News Now – June 20, 2016

MedPAC Issues June Report to Congress
Last Wednesday, the Medicare Payment Advisory Commission released its June report to Congress, which annually looks at issues affecting the Medicare program and healthcare delivery and services. The report also recommends a prototype design for a unified prospective payment system for skilled nursing facilities, home health agencies, inpatient rehabilitation facilities and long-term care hospitals, as required by the Improving Medicare Post-Acute Care Transformation Act of 2014. The Centers for Medicare & Medicaid Services is expected to use the prototype to develop a PAC PPS by 2023. As previously proposed by MedPAC, the prototype would pay for post-acute care services based on a patient's clinical characteristics rather than the site of service. Also as previously proposed, the report recommends reducing dispensing and supplying fees for Medicare Part B drugs to rates similar to other payers, and giving isolated rural hospitals the option to convert to an outpatient-only model that would be sustainable in a community with declining inpatient volumes.
 
The commission also recommends changes to the Part D program to lower program costs and protect beneficiaries with high costs. In addition, the report presents an analysis of Medicare telehealth services, including use of telehealth in Medicare Advantage, and recommends expanding the use of waivers in Center for Medicare & Medicaid Innovation programs to include a broader range of telehealth services.
 
Source: AHA News Now – June 16, 2016

 
FDA Seeking Comments on Benefit-Risk Draft Guidance
The FDA welcomes AHRMM members to comment on FDA’s draft guidance: “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions”. The purpose of this guidance is to clarify how the FDA assesses benefits and risks for medical devices already available on the market. The docket number is FDA-2016-D-1495.
 
Click here for more information including instructions on submitting comments.
 
This draft guidance focus on the factors the FDA may consider when making decisions related to compliance and enforcement actions for a specific medical device company, or when making decisions that may affect a medical device’s availability on the market in general. In addition to evaluating scientific and clinical data, the FDA may also consider the patient perspective and other real world data when determining a device’s safety profile. 
 
The FDA believes the use of this information by medical device companies in their own benefit and risk assessments may help them to better determine whether to initiate a recall to correct a defective product or remove it from the market.
FEATURED MEMBER BENEFIT
AHRMM Fellow Program
The designation of AHRMM Fellow (FAHRMM) recognizes current AHRMM members for reaching the highest level of education and achievement in both the Association and in the supply chain field.
 
Only presented to Certified Materials & Resource Professionals (CMRP) and current AHRMM members, FAHRMM status is designated to those who have excelled in specific areas of the supply chain and have submitted an approved, original, unpublished paper on a current aspect of materials or supply chain management.
 
Visit www.ahrmm.org/Fellow for FAHRMM designation requirements and additional information on the program.
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