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Keeping health care ahead of the curve with the latest innovations is our specialty and has been for nearly 50 years. Core Business EMS Sales Hospital.

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Presentation on theme: "Keeping health care ahead of the curve with the latest innovations is our specialty and has been for nearly 50 years. Core Business EMS Sales Hospital."— Presentation transcript:

1 Keeping health care ahead of the curve with the latest innovations is our specialty and has been for nearly 50 years. Core Business EMS Sales Hospital Sales Product Development and Engineering Biomedical Clinical Services Mercury Manufactured Products Medical Gas Certification Home Care

2 Medical Device Industry Current Challenges

3 Federal Mandate Electronic Medical Records by 2014. Hospitals face penalties of 1% in 2015, incrementing each year up to 5% as Medicare/Medicaid reimbursement reductions. Federal grants and funding, Medicare incentive payments, to assist with implementation, from American Recovery Reinvestment Act. Connectivity With EMR implementation process, customers are now demanding new electronic devices have connectivity.

4 U.S. HOSPITALS ALSO FACING NRP (Neonatal Resuscitation Program). – 2012 Guidelines * Laryngeal Masks* Blender * Medical Air / Compressor * S P 0 2 JCAHO – 10/24/11 – Laryngoscope blades can no longer lay in drawers or on towels. Must be wrapped SCIP (Surgical Care Improvement Project) ASA Sedation Standard 3.2.4; AHA, ERC, Joint Commission guidelines. – CO2 Monitoring

5 Vendor Credentialing for hospital access - no common standard.

6 Capital Funding Access challenges for hospitals.

7 New Sunshine Law disclosure regulation for financial relationship reporting with physicians. NPI information at registration so if the exhibitor gives away anything (food, beverage, etc.) the vendor will have the details for reporting to HHS.

8 Many device companies developing consumables with chip recognition to limit competition, allowing them to maintain a foreseeable revenue stream.

9 The product sale cycle in a typical hospital has greatly lengthened and involves a variety of other players beyond clinicians, legal, VAC/VAT, procurement, finance. One recent comment which appeared in the Grey Sheet, stated all products are considered commodities, unless proven otherwise. '.

10 Reimbursement Coding Change ICD-9 to ICD-10 (International Classification of Diseases). U.S. is behind the rest of the world. This change would replace the current set of 14,000 diagnosis codes to approximately 69,000 codes. Implementation date October 1, 2013, was delayed on 2/16/12 by HHS for unspecified time.

11 Centers for Medicare & Medical Services (CMS) reimbursement cutbacks, including additional percentage reduction for missing EMR/EHR implementation.

12 (UDI) Unique Device Identifier Passed by congress in 2007. Implementation date 2013. FDA still has not issued final rules to industry. Initial proposed regulation 60-70 pages after a 200 page preamble. The senior FDA advisor once stated Its not written in a way thats easy to understand. Its a legal document, written by our lawyers, reviewed by our lawyers, I dont understand most of it Continued next page…..

13 EU drafting guidelines UDID (Global Database) Include GMDN (Global Medical Device Nomenclature) While these UDI labeling changes are in process, FDA is proposing to poll healthcare providers on how to best standardize medical device labeling, which is to take place in 2012.

14 FDA plans for on-line labeling repository for all devices, as part of FDA reform plan. FDA just announced plans to survey industry for comments related to its Emergency Shortages Data Collection System. System is available only to CDRH Emergency Shortage Team and Senior management. Separate from this system, U.S. Department of Commerce Bureau of Industry and Security conducted a similar mandatory survey in 2011.

15 Global Location Number (GLN) as a common numbering system to identify any legal entity/trading partner.

16 Two bar code standards: GS – 1 (formerly UCC) Uniform Code Counsel HIBC – Health Industry Business Council Outside U.S., some countries ignore; mandating use of another format

17 Global Medical Device Nomenclature Pending addition to labeling rule changes

18 Healthcare Bill In 2013 most medical devices will be subject to 2.3% Medical Device Tax unless congress intervenes. IRS has published a draft Proposed Rule Making Regulation on February 3, 2012. Supreme Court hears arguments week of March 26, 2012, with ruling by June, 2012. First Excise tax payment due January 29, 2013.

19 FDA Reforms (MDUFA III) Review and possible rewrite of the entire device approval process including IOM (Institute of Medicine) recommendation to scrap current 510k process and start over. 510k statute review time (90 days) missed 510k costs to double by 2017 Establishment registration fees to increase 50% by 2017.

20 European Union (CE) requirement changes. Increasing individual country requirements (not harmonized).

21 Underwriters Laboratories (UL) New and Updated Electrical Standard for Medical Devices: IEC 60601-1 (800 pages)

22 New Outside Entity Hospitals contracting with outside entities (i.e. MedApproved) for prescreening new technologies before introduction into system. http://www.medapproved.com Hospitals contracting with outside parties for recall management i.e. (RASMAS (Risk and Safety Management Alert System)). http://www.rasmas.noblis.org

23 Patent Reform Law First to file vs. previous first to invent. May impact how industry interfaces discloses with developers.

24 FDA PREDICT IMPACT Introduction of new importation clearing system PREDICT dramatically affecting all companies importing materials

25 ___________ Mandatory CO2 Monitoring SCIP NRP 2012 JCAHO DEC 21 2012 Myan Calendar Runs Out (Doomsday?) JAN 1 2013 Medical Device Tax (PRICES WILL GO UP!) JAN 29 2013 1 ST medical device excise tax payment due MAR 16 2013 Patent Law Reform takes effect SEP 30 2013 UDI Implementation Date from CDRH OCT 1 2013 ICD10 Implementation (NOW DELAYED) 2014 EMR/EHR Takes effect National Strategy for Global Supply Chain Security FDA Poll to standardize medical device labeling.

26 Questions? Thank You


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