STATEMENT OF WORK

Sterilizer Purchase DHN-Europe

1. Background

The Defense Health Agency (DHA) European Network has a requirement for the purchase, shipment, and operator training via telephonic support on all standardized Tabletop Steam Sterilizer platforms. The DHA Europe Network operates Medical and Dental Treatment Facilities ((MTFs and DTFs), across multiple European host nations which includes Germany, Italy, Belgium, the United Kingdom, Spain, and Turkey). Standardizing medical sterilizers across these facilities is critical to ensuring a uniform Sterility Assurance Level. The equipment is required to aid in preventing the spread of infection and cross-contamination among both patients and staff by thoroughly disinfecting dental/surgical instruments prior to use.

2.0. Description of supplies/services

2.1. The Government requires sterilization equipment to replace the existing units that are at or beyond their life expectancy.

2.2. Select equipment shall be capable of processing a wide range of surgical instruments with multiple rack configurations.

2.3. Equipment Class: The requirement is for commercial steam tabletop sterilizers (autoclaves), comprising Large-Capacity Tabletop Sterilizers (~85L) and Class B Pre-Vacuum Tabletop Sterilizers (~27L) for medical and dental instrument reprocessing.

2.4. The sterilizers shall be compliant with ANSI/AAMI ST79 and ISO 17665-1 standards for moist heat steam sterilization, as well as applicable EN 13060 and EN 285 standard.

2.5. Door Safety Systems: All units shall incorporate automated safety locking mechanisms that prevent door opening while the chamber is pressurized. In the event of a power failure, the chamber shall allow safe manual opening once depressurized.

2.6. Power Failure: In the event of a power failure, the door shall be capable of being opened manually. A door interlock feature is provided to prevent cross-contamination.

3.0. Scope

3.1. The contractors shall provide all transportation required to ensure onsite delivery.

3.2. Identification. All sterilizers shall be compliant with the regulations and standards of the Food and Drug Administration (FDA) and The Joint Commission (TJC). However, when available, the unit shall have CE Mark per Governing Medical Devices Directive 93/42/EEC as amended by 2007/47/EC. This does not preclude the requirement for FDA Approval.

4.0. System Requirements for Equipment Standardization

4.1. Standardization. All procured sterilizers must utilize a standardized user interface, control system, and parts inventory to ensure ease of operator transition and simplify the equipment maintenance program across the DHA Europe Network.

4.1.1. Configurations. The Contractor shall offer various chamber sizes ranging from small tabletop sterilizers (for dental and health clinics) to include larger bulk configurations.

4.1.2. Water Reservoir. The Reservoir shall hold no less than 4.5 liters of water in order to ensure sufficient steam generation.

4.1.3. The unit shall contain a removable water filter (pump strainer) to ensure clean water is used during system operation.

4.1.4. Water Quality. The offered equipment's steam generator/condensate water supply must comply with EN 285 water quality requirements for steam sterilization.

4.1.5. Operating Temperature. The temperature range shall be from 250°F to 274°F (121°C to 134°C) to ensure effective sterilization.

4.1.6.Drying System: All sterilizers shall be equipped with an automated closed-door drying system incorporating a replaceable 0.2 µm HEPA air filter (or post-vacuum drying) to prevent recontamination of sterile loads.

5.0. System Safety

5.1. Chamber Lockout. The unit shall have a double safety locking device that prevents the door from opening while the chamber is pressurized and an automatic shut-off at the end of both sterilization and drying cycles.

5.2. Insufficient Water Detection. The sterilizer shall automatically shut off in the event the water level falls below the minimum required level for operation.

5.3. Safety Lockout Feature. The sterilizer shall employ a feature that prevents a cycle from starting if the door is not fully closed.

5.4. Door Interlock. The sterilizer shall have a door interlock feature that prevents the door from opening while the chamber is pressurized, ensuring user safety during operation.

6.0. Contractor Requirements

6.1. The sterilizer shall be compliant with all the regulatory guidelines identified in para 3.2.

6.2. Telephonic Support. Both Operator and Technical Support shall be provided as needed to the end user to ensure the equipment is properly placed into service and remain fully operational during the warranty period. Telephonic support shall be made available Monday through Friday, 0800 to

1700 Central European Time (CET) / Germany Local Time, excluding U.S. Federal and Host- Nation German holidays

6.3. Training and maintenance. The contractor shall provide basic operational and user-level maintenance training for each location. Training to be scheduled and coordinated upon delivery.

The contractor shall issue formal Training Certificates and written Manufacturer Authorization certifying military Biomedical Equipment Technicians (BMETs) and clinical staff to perform user-level maintenance and routine parts replacement without voiding the manufacturer’s commercial warranty

6.4. Onsite or remote training shall be determined and agreed upon between the medical facility and the Contractor.

6.5. Operator Manuals and Technical Literature. The Contractor shall provide no less than two copies of operator and technical manuals. All manuals or accompanying literature shall be in English and provided to each location.

7.0. Operating Voltage

7.1. All equipment and components requiring standard electrical power shall be 230v, 50/60 Hz compliant, and capable of operating on standard European electrical power.

7.2. Equipment requiring an external step-down or step-up transformer shall not be allowed.

8.0. Warranty

8.1. The equipment provided shall have a warranty period of no less than 12 months (parts only) and include an additional 12 supplemental warranty for up to a total of 24 months. If required, the optional 12 months shall be provided under a separate agreement after the initial warranty period.

A complete copy of the manufacturer's commercial warranty terms and conditions must be provided in English with quote submission and equipment delivery.

9.0. Delivery

9.1. Shipping and handling costs shall be all inclusive with this purchase.

9.2. The Contractor shall be responsible for coordinating, packing, shipping, and receipt of all the equipment to include all required hardware and software associated with the equipment.

9.3. Below are the desired delivery Locations and Points of Contact (POC) for this contract:

Site Property Management POC

Site Property Management POC

Landstuhl Regional Medical Center PMB-Warehouse, Attn: Joachim Bannes Bldg./Geb. # 3739 66849 Landstuhl-Kirchberg, Germany

DSN: 314.590. 4654

COM: +49 06371.9464.4654/6347

Email: pia.m.kessler.ln@health.mil

86th MDSS/MEMO Section Lincoln Blvd., Geb. # 2497 Attn: Ms. Rosemarie Joyner 66877 Ramstein-Flugplatz, Germany

DSN: 314.727.3393

COM: +49 06371.46.2430

Email: rosemarie.joyner.ln@health.mil

Medical Logistics Purchasing POC 52 Medical Group HCOS/SGGM Bolling Drive. # 550, Attn: SrA Noah Cardiel 54529 Spangdahlem-Air Base, Germany

DSN: 314.452.3316/3673

COM: +49 06565.61.3316/3325

Email: noah.s.cardiel.mil@health.mil

Medical Materiel Management POC 31 MDG/SGSM, Attn: TSgt Nicholas A. Kozak 31 LRS/LGRD Cargo Movement Element Bldg. 1029 Aviano, Italy 33081

COM: +39 043.430.6512

Email: nicholas.a.kozak2.mil@health.mil mailto:pia.m.kessler.ln@health.mil mailto:rosemarie.joyner.ln@health.mil mailto:noah.s.cardiel.mil@health.mil mailto:nicholas.a.kozak2.mil@health.mil