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Medical Equipment Requirements Definition and Technical Writing

Medical Equipment Requirements Definition and Technical Writing. National Conference Center (NCC) Lansdowne, VA June 4-6, 2012. FOR OFFICIAL USE ONLY. Purpose and Objectives. Context

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Medical Equipment Requirements Definition and Technical Writing

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  1. Medical Equipment Requirements Definition and Technical Writing National Conference Center (NCC) Lansdowne, VA June 4-6, 2012 FOR OFFICIAL USE ONLY

  2. Purpose and Objectives • Context • Requests for Equipment/Maintenance contracts must have clear and accurate requirements to ensure timely procurement and to minimize issues over the life of the equipment/contract • Purpose • Develop an understanding of the information required to formulate proper technical specification/ requirements for the submission process for procurement of equipment • Develop an understanding of how to formulate requirements for maintenance requirements • Objectives • Have an understanding of the procurement process and important factors related to requirement generation • Gain ability to generate requirements for both equipment and maintenance for submission into the procurement process FOR OFFICIAL USE ONLY

  3. Equipment Procurement • Technical Requirements is the most crucial portion of a Command Equipment Request • What products, available on the market, are capable of meeting your salient/minimum requirements • Allow for competition whenever possible • Sole Source Justification must be based on salient characteristics provided • If requirements are sufficiently detailed, equipment that meets your minimum requirements will be procured FOR OFFICIAL USE ONLY

  4. Equipment Procurement • Not Acceptable • Preferred model product information • Vendor Language • “See quote” • Utility/ Dimensional information of the user preferred model itself FOR OFFICIAL USE ONLY

  5. Equipment Procurement • Sole Sources • Only one vendor/model is capable of meeting the minimum requirements specified. • If justification uses “Best” or “Better”, not an acceptable sole source. FOR OFFICIAL USE ONLY

  6. Functional Requirements • Define what functionality the unit/system will be used to achieve • What environment/dept will it be used in? • Sterile? • What patient population will it be used on? • What applications/ treatments/ capabilities should it be capable of providing? • What is the correct ECRI Nomenclature? FOR OFFICIAL USE ONLY

  7. Technical Specifications • Ranges/ Min-Max values (…shall be capable of a power range of 150W – 200W…) • Word usage is important • Room/Space Dimensions -space intended for equipment, not dimensions of suggested model (Unit of Measure) • Electrical Requirements • 50Hz OR 60Hz, amperage of outlet, single phase… • Interface with other systems • Anesthesia Unit/Monitoring to Innovian ARMD • Accessories Requirements to meet intended functionality FOR OFFICIAL USE ONLY

  8. Technical Specifications • Cleaning Requirements? • New Technology – describe new technology and how it differs from previous technology and how it will benefit patient care • Facilities Issues that affect specifications • Water Supply • Clean Power • Med Gas Availability FOR OFFICIAL USE ONLY

  9. Other Requirements • Required Delivery Date (consider ARO) • Lease vs. Buy / Benefit-Cost Analysis • Information Assurance • Operating System EOL (Windows XP – April 2014) • Installation/Trade-Ins/Turnkeys • Equipment Transport through Facility • Maintenance Requirements • First Year Warranty “Additions” • Part of Navy-wide Centralized Maintenance Contract? • Site Specific Requirements • Base Security/Access Requirements • Safety Standards (OCONUS) FOR OFFICIAL USE ONLY

  10. Research Resources • The ECRI Institute • Product Comparisons • Guidance Articles and Recommended Specifications • Vendor list by Nomenclature/Device Code • Clinicians/BMETs • Previous Year Exhibitor Lists from Annual Conferences • FDA’s Manufacturer and User Facility Device Experience (MAUDE) • Service Inventories (JMAR) FOR OFFICIAL USE ONLY

  11. Maintenance Requirements • Identify what is to be serviced. • CLIN out each product with an individual price, no bulk contracts. (It must be possible to adjust contract pricing based upon a product being removed from service.) FOR OFFICIAL USE ONLY

  12. Quality Assurance on Service • Means of Quality Assurance – How do you plan to evaluate vendor performance? • Uptime Guarantee • OEM Parts • Hours of Service • Inspection for condition (OEM will accept unit at no cost to government.) FOR OFFICIAL USE ONLY

  13. Level of Service • Identify the level of service required: Preventive Maintenance Only? (And if so, WHY?) • Scheduled and Corrective Maintenance, exclusive of parts? • Scheduled and Corrective Maintenance, Inclusive of parts? • Inclusive of Glassware? • Coverage can vary by vendor (digital detectors, image intensifiers, CCD cameras, etc.). FOR OFFICIAL USE ONLY

  14. Hours of Service • When to consider 24/7 Service: • If you only have one product • Your facility is open and you use that product 24/7 • When 24/7 service may not be required: • If you have more than one of the product • If that service is only open 7-5 M-F • Perform a cost benefit analysis with every product: • Expected cost of the higher level service versus the expected loss if that service is not available? FOR OFFICIAL USE ONLY

  15. Personnel Requirements • National Agency Check • Common Access Card • Base Access • Training • Experience FOR OFFICIAL USE ONLY

  16. HIPAA Business Associates Agreements • Business Associates Agreements are required for a majority of medical equipment contract. • Subcontracting? (Justify need to know on a subcontract?) FOR OFFICIAL USE ONLY

  17. Information Assurance • Compliance with DOD Information Assurance Requirements: • Software Maintenance • Bug Fixes • Cyber Threat Protection FOR OFFICIAL USE ONLY

  18. “Best Effort Contracts” • A Best Effort Contract says: • You are maintaining obsolete Equipment, or • You are contracting with someone not competent • Under ANY circumstances, you should not be in a situation where a Best Effort Contract is appropriate. • If you are considering this, CALL NMLC Engineers prior to proceeding. FOR OFFICIAL USE ONLY

  19. What happens if a vendor can’t fix the equipment? • The contract should clearly state if the contractor can not fix the equipment, are they obligated to replace it? • If so, with a used product, new product of same capability or new product from same vendors? • If not, why was there a contract? FOR OFFICIAL USE ONLY

  20. First Look • Most vendors have minimal price reduction for first look contracts, because most facilities failed to honor their commitments under such contracts. • The facility should maintain at least one trained person for the product under a first look contract. • That person is obligated to attempt repair, spending approximately 4 hours trying to repair prior to calling for backup. FOR OFFICIAL USE ONLY

  21. Questions FOR OFFICIAL USE ONLY

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