SS Statement of Work.docx

STATEMENT OF WORK/NEED

INTRODUCTION:

The Functional & Applied Biomechanics (FAB) Section in the Rehabilitation Medicine Department (RMD) at the National Institutes of Health is located in the world's largest clinical research facility - the Mark O. Hatfield Clinical Research Center. This laboratory has an outstanding history of technology development, translational research, and clinical applications in the field of human movement analysis for rehabilitation research and patient care. FAB performs research on a variety of patient populations. Multiple support protocols involve patients with high falls risk, so a safety system that allows for patients to continue their natural walking is imperative to our research.

MINIMUM REQUIREMENTS / SPECIFICATIONS/ SALIENT CHARACTERISTICS:

All items must be new. Used or remanufactured equipment will not be considered for award.

· Functional Performance: Capable of dynamic (while walking, sitting, standing, etc) unloading, tracking patient movements (initiating walking, slowing down, etc), fall prevention (system locks to prevent patient from hitting floor)

Robotic Trolley:

o Capable of static unloading (0-450 lbs) o Capable of dynamic unloading (10-200 lbs) o Capable of tracking patient movements up to 5 mph o Stealth detection (collision avoidance for multiple robotic trolleys on the track) o Winch for safely raising and lowering patients in a controlled manner

User Interfaces:

o Touchscreen computer on mobile cart o Wireless tablet in case with belt clip Track:

o Precision cut aluminum I-beam, powder-coated bright white.

o UL approved power conductor, shape and configuration per track layout o Up to 100 feet standard, shape customized to space

Software:

• Fall Protection o Distance: Set the number of inches before fall is caught o Velocity: Fall is caught when unsafe speed of descent is detected. Useful on stairs.

o Disabled: For higher-level patients who need body-weight support o Dynamic Fall Recovery: Dynamic BWS remains on during fall recovery o Extra support immediately after a fall while returning to standing o Fall Cushioning Technology: Softens the impact of a fall

• Patient Management o HIPAA compliant database o Track metrics per session or summary over time o Apply perturbations during stationary or walking activities o Vary perturbation strength, timing and direction

DELIVERY TERMS:

New system will be delivered to the Rehab Medicine Department, Rm 1-2413, NIH, MSC 1609, Bethesda, MD 20892

TRAINING: Yes

The vendor must provide on-site training and provide online materials.

INSTALLATION:

The vendor must remove the old system and install the new system.

PERIOD OF PERFORMANCE: n/a

WARRANTY: Two year warranty

EXTENDED MAINTENANCE SERVICE: n/a

INSPECTION AND ACCEPTANCE: The government will inspect and accept goods and may perform operational test to ensure the equipment performs in accordance with the original equipment manufacturer (OEM) specifications.

SOFTWARE – Contractor shall provide software configuration and updates as required to the government.

ELECTRICAL n/a

REGULATORY COMPLIANCE:

All contractor furnished products must be UL and C-UL classified, ISO (International Organization for Standardization), and CE (European Conformity) compliant. They must meet all FDA clearances, and have received ADA acceptance.

12.1 Proposed medical devices/equipment must be in compliance with the FDA Good Manufacturing Practices for medical devices and equipment. The equipment shall be in compliance with the FDA Safe Medical Devices Act, “Safety Medical Act of 1990” by Frank E. Samuel, Jr.

12.2 System components where required must possess 510K certifications and produced by a manufacturer with ISO 13485 Certification or equivalent. Contractor shall provide a copy of their certification with their offer.

510k Certification: http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/default.htm and/or ISO 13485 Certification: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm212795.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=ISO%2013485%20Certification&utm_content=1 Drug Applications and Current Good Manufacturing Practice (CGMP) Regulations http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

The approval process for new drug and generic drug marketing applications includes a review of the manufacturer's compliance with the CGMP. FDA inspectors determine whether the firm has the necessary facilities, equipment, and skills to manufacture the new drug for which it has applied for approval. Decisions regarding compliance with CGMP regulations are based upon inspection of the facilities, sample analyses, and compliance history of the firm. This information is summarized in reports which represent several years of history of the firms.

FDA can issue a warning letter or initiate other regulatory actions against a company that fails to comply with Current Good Manufacturing Practice regulations. Failure to comply can also lead to a decision by FDA not to approve an application to market a drug.

This web page provides links to resources to help drug manufacturers comply with the Current Good Manufacturing Practice regulations.

Federal Regulations Code of Federal Regulations (CFR)1. The final regulations published in the Federal Register2 (daily published record of proposed rules, final rules, meeting notices, etc.) are collected in the CFR. The CFR is divided into 50 titles which represent broad areas subject to Federal regulations. The FDA's portion of the CFR interprets the Federal Food, Drug and Cosmetic Act3 and related statutes. Section 21 of the CFR contains most regulations pertaining to food and drugs. The regulations document the actions of drug sponsors that are required under Federal law.

· 21 Code of Federal Regulations Part 2104. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs.

· 21 Code of Federal Regulations Part 2115. Current Good Manufacturing Practice for Finished Pharmaceuticals.