Stryker System 9 LSJ Redacted.pdf

These parts offered by Stryker are the only parts on the market that are fully compatible with the products that have already been purchased, in large quantity, and are currently in clinical use in the operating room and are capable of performing highly critical total joint arthroplasty, total joint revisions, sports medicine, trauma, small bone, cardiac, and other osteotomy procedures.

Existing equipment in use and on hand includes but is not limited to sterilized surgical trays and the following drill bits and saw blades:

0277-096-275 RCP BL DL SD OFF 70X.64X12.6MM

0298-097-100 STERN BLD OFF 32.0X0.8X6.3MM

1607-002-035 4.0MM EGG BUR

1608-006-139 4.8MM ROUND FAST CUTTING BUR

2296-003-105 PREC THIN 9.0X0.38X18.5MM

2296-003-106 PREC THIN 13.0X0.38X34.5MM

2296-003-106 PREC THIN 13.0X0.38X34.5MM

2296-003-114 PREC THIN 7.0X0.38X18.5MM

2296-003-125 PREC THIN 9.0X0.38X31.0MM

2296-003-206 PREC THIN 12.0X0.38X34.5MM

2296-003-411 PREC THIN 9.0X0.38X11.5MM

2296-003-412 PREC THIN 5.5X0.38X18.0MM

2296-003-414 PREC THIN OFF 5.5X0.38X25.0MM

2296-033-105 PREC 9.0X0.51X18.5MM

4118-127-090 DUAL CUT SAGITTAL BLADE

4125-089-090 DUAL CUT SAGITTAL BLADE

4125-127-090 DUAL CUT SAGITTAL BLADE

The current orthopedic marketplace consists of manufacturers that produce their own line of total joint, trauma, and sports medicine products. Unlike many other industries, product selection in the orthopedic industry is not based solely on price and is overshadowed by physician preference/experience and highly specialized training on use of specific surgical items. A physician’s decision to use a particular manufacturer’s product is based on the technical characteristics of the products that are expected to produce a higher quality of life for their patients or achieve certain surgical results. Stryker products and the surgical procedures used are unique and proprietary, as is the industry standard, and require highly specialized training on the part of the physician. Once trained and comfortable with a particular manufacturer’s products and the surgical procedure, the physician will likely use that manufacturer’s products for the duration of their career.

For the 1,000 specialized orthopedic surgeries performed annually at the Portland Oregon Department of Veterans Affairs Hospital reducing risk to the patient is paramount. The required products are interoperable with existing Stryker units in place at the facility (listed above) and utilizing products from two different manufacturers (incompatible by design by the manufacturers), greatly increases risk to patient safety. If the wrong component is accidentally placed into the wrong drill or saw and used for a patient procedure, due to the high rotation speed of 1,500 rpm and 16,000 cpm the component could wobble, shake, or even spin out of the handpiece, endangering the life of not only the patient, but also the lives of the staff.

All surgical instruments, components, drill bits, saws, etc. are sent to SPS (Sterile Processing Service) for decontamination, cleaning, and re-sterilization. They are placed on trays and sterilized. SPS does not segregate different manufacturers equipment to separate groups during this process. Therefore, during this process, if there are both Stryker equipment and components (already in current use in the OR) and another vendor’s drills and components in the sterilization process, mixing of components will occur. This will result in a high probability that components from one manufacturer being mixed with the alternate manufacturer and put into the sterile pack.

When the sterile pack is delivered to the OR and placed in the surgical suite, and it is found that there is a mix up between the drill and the components, it results in either complete cancellation of the surgery or significant delay in the surgery. If the case is delayed, this will cause the patient to be under anesthesia for longer than they should be, and this could result in adverse outcomes during recovery, up to and including patient death. Stryker has full FDA clearance, but only for Stryker branded drills, burrs, saws, etc. To use alternate vendor components on Stryker neuro drills, or to place Stryker components into a non-Stryker neuro drill voids the FDA clearance, results in their exemption from liability and full liability is placed on the Portland VA. All products used must be FDA 510k clearance and since mixing components voids that clearance it simply cannot be done.

No other manufacturer has the capability of meeting the Portland Oregon Department of Veterans Affairs Hospital requirements listed above. Only the Stryker items are capable of satisfying the requirement.

The customer’s decision regarding clinical preference was arrived at as a result of past experience with various manufacturers’ product lines, clinical use, and consideration of surgeon’s preference. This suggested source can furnish the requirements to the exclusion of other sources. In considering the market research noted by the Portland Oregon Department of Veterans Affairs Hospital, I concur with the results of their technical evaluation.

5. DLA Troop Support has already determined the prices of the supplies under the ECAT Multiple Award Schedule Program fair and reasonable based on a favorable comparison to other than certified cost or pricing data.

This acquisition represents the best value to the Government consistent with FAR 8.404(d).

7. Market research was conducted using the FDA website, google, ECRI, and published literature in order to determine which orthopedic power tool system, components, and accessories best meets the needs of Portland Oregon Department of Veterans Affairs Hospital.

Biomedical Engineers and OR Equipment managers were consulted and part of the overall analysis process. Within the product category of drill and saw systems capable of performing highly critical orthopedic surgeries including total joint arthroplasty, total joint revisions, sports medicine, trauma, small bone, cardiac, and other osteotomy procedures, including fine bone dissection for cranial and spinal procedures the available products identified was Zimmer Biomet X. The Minimum requirements taken into consideration were compatibility with existing equipment, ease of use, price, and clinical preference. However, this item does not meet the minimum requirements due to lacking the compatibility with sterilization trays and interfaces currently in place at the facility. Additionally, Stryker’s “twist and lock” battery mechanism ensures that batteries are properly attached at all times and can remain in their hygienic wrapping while being charged, ensuring that they are sterile for use. The compatible trays currently on site are Asculap Containers and insert trays. The Zimmer Biomet X series was researched, and it was determined that this product is incapable of being sterilized in Portland Oregon Department of Veterans Affairs Hospital's current sterilization trays, nor is its interface compatible with the Stryker system’s accessories and trays currently existing on station. Additionally, drill systems have many components that are non-sterilizable and can lead to contamination of the sterile field. Other manufacturers offer proprietary equipment, meant to ensure that only their branded components work with their branded drills. Failure to do so introduces risk of patient injury and death, and extreme liability for the Portland Oregon Department of Veterans Affairs Hospital.

No manufacturer will support or allow themselves to be held liable if non-same branded components are used on their equipment. The Stryker drill and saw products are the only items that are compatible with current inventory Only the Stryker items listed in table above are capable of satisfying the requirement of the Portland Oregon Department of Veterans Affairs Hospital.

Furthermore, the interface and functionality of the Stryker System 9 is similar to what is currently in use at the hospital while the Zimmer Biomet X interface is dissimilar and would require further physician training for clinical use. The Zimmer systems are not compatible with existing sterilization trays, accessories, and attachments already in place at the Portland VA Facility and is not interoperable with existing Stryker units in place at the facility (listed above).

Utilizing products from two different manufacturers (incompatible by design by the manufacturers) would greatly increase risk to patient safety and is outside the standard of care. A physician’s decision to use a particular manufacturer’s product is based on the technical characteristics of the products that are expected to produce a higher quality of life for their patients or achieve certain surgical results. Stryker products and the surgical procedures used are unique and proprietary, as is the industry standard, and require highly specialized training on the part of the physician. Once trained and comfortable with a particular manufacturer’s products and the surgical procedure, the physician will likely use that manufacturer’s products for the duration of their career. The purchase of the Stryker system would ultimately decrease the chance of user error during surgery in comparison to the purchase of a new and incompatible system such as the Zimmer Biomet X. No further physician training to operate the Stryker System 9 Power tools would be required as many of Portland Oregon Department of Veterans Affairs Hospital's surgeons are familiar with the Stryker platform.

In conclusion, the market research revealed that there are other drill systems available, such as the Zimmer Biomet X, however, none of associated products and accessories meet the need of Portland Oregon Department of Veteran Affairs Hospital. Stryker was able to provide a single system that met the unique needs of the multitude of surgical specialties performed at Portland VA Medical Center and are the only items compatible with current inventory while guaranteeing sterile operating fields, lasting battery life, and interface experience with surgeons. Only the Stryker System 9 items are capable of satisfying Portland Oregon Department of Veterans Affairs Hospital's requirement.

8. ECAT vendors have the opportunity to add products that fall within scope of the ECAT contract regularly, thereby increasing competition. DLA Troop Support will continue to attempt to locate other acceptable sources for future requirements at Portland Oregon Department of Veterans Affairs Hospital as they arise; however, any new items would need to meet all of the Portland Oregon Department of Veterans Affairs Hospital's requirements.

9. As the Contracting Officer, I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.

DANIEL LINK / DATE

CONTRACTING OFFICER

I hereby certify that the requirements which form the basis of this justification are accurate, that these supplies meet the Government’s minimum needs, and that this justification is accurate and complete to the best of my knowledge and belief.

QUALITY ASSURANCE SUPERVISOR

I have reviewed this justification and recommend approval.