Bull Shark Medical Quality Policy

Bull Shark Medical is a reseller/distributor of unused Prescription Medical Devices ("PMDs") used in surgical facilities, hospitals, and doctor's offices. Bull Shark Medical purchases its inventory from a variety of suppliers, including hospitals, surgery centers, medical device distributors and other resellers. Bull Shark Medical, a reseller/distributor/wholesale medical broker of PMDs in the secondary market, is not regulated by the Food and Drug Administration ("FDA"). 

This policy was undertaken because the FDA has made a regulatory decision to limit the regulatory tracking, registration, and listing requirements for distributors of prescription medical devices. The compliance program includes specific purchasing protocols to validate the nature of those sellers from which Bull Shark Medical purchases inventory; these protocols include the following elements:(a) Restrictions on eligible vendors; (b) Required paperwork for all transactions including purchase order, invoice and bill of sale; (c) Restrictions as to payment method; (d) Quality Control Procedures to ensure the accuracy and integrity of the products upon receipt, storage and distribution back into surgical facilities.

Bull Shark Medical operates as a compliant commercial enterprise and has established quality control systems. The company's facility is a climate-controlled warehouse maintained by our inventory control specialists. The facility is under 24-hour video / security surveillance and utilizes an advanced inventory tracking software that resides on protected servers in offsite data centers where data is backed up daily and stored securely. 

Our Process

Bull Shark Medical currently enforces the following protocols to ensure the safety and efficacy of secondary market ("PMDs") within the market:

1. When purchasing PMDs from Bull Shark Medical, the customer must be a person or entity with authority to own PMDs pursuant to Title 21, United States Code.

a. The customer may be a provider of medical services (ex. hospital, clinic, surgical center).

2. All sellers to Bull Shark Medical must be able to prove they have good and marketable title to the merchandise being sold.

a. Proof of the purchase of the merchandise along with a copy of the invoice and evidence of payment for the merchandise.

i. The proof of purchase must show that the merchandise was purchased from a person or entity with authority to own the merchandise pursuant to Title 21 of the United States Code.

ii. Merchandise was paid for in a routine business way, typically a company check. The payee of the check must match the name of the party who sold the goods to the vendor.

iii. If the merchandise is capital equipment it should bear the manufacturer's original serial number in all places where the serial number is engraved, embossed, or attached to the device.

3. All sales transactions made by Bull Shark Medical require the following documentation:

a. A purchase order addressed to Bull Shark Medical for the merchandise. The purchase order must show the customer's name and full business address.

b. All Bull Shark Medical sales are concluded with an invoice.

c. Bull Shark Medical invoices clearly show Bull Shark Medical's federal tax identification number.

d. All Bull Shark Medical invoices must be paid by company check or cashier’s check made payable to Bull Shark Medical. Wire transfers and major credit cards are also accepted.

Quality Control Procedures

Receiving procedures for PMDs- Bull Shark Medical has adopted protocols to implement this section as necessary to protect the public health, safety, and welfare. Such rules shall include all receiving measures used by Bull Shark Medical.

PHYSCIAL EXAMINATION OF MATERIALS AND RECORDS:

a. Upon receipt, each outside shipping container must be visually examined for identity and to prevent the acceptance of contaminated PMDs that are otherwise unfit for distribution. This examination must be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.

b. Upon receipt, the Company must review their issued Purchase Order computer records as related to the acquisition of PMDs for accuracy and completeness, considering the total facts and circumstances surrounding the transactions and the domestic Vendor, Surgery Center and/or Hospital involved.

RETURNED, DAMAGED, OR OUTDATED PMD(s):

a. PMDs that are outdated, damaged, deteriorated, misbranded, or adulterated must be quarantined and physically separated from other PMDs until they are destroyed or returned to their supplier.

b. A quarantine section must be separate and apart from other sections where PMDs are stored so that the PMDs in this section are not confused with usable PMDs.

c. All stored PMDs must be examined at least every month for expiration dating and for those that the expiration date has passed must be removed and quarantined.

d. If the conditions under which a PMD has been returned cast doubt on the PMD's safety, identity, or quality, the PMD must be destroyed or returned to the supplier.

PHYSICAL PMD(s) RECEIPT:

1. All PMDs are physically received one of two methods:

a. UPS

b. FED EX

2. Upon physical arrival and delivery of the PMD, the following must be performed:

a. Log the receipt of the PMD on the Receiving Log (See 3.1: Receiving Log) recording the date of receipt, the Delivery Method, the Facility where the PMD was shipped from, the number of boxes received and the PO#.

b. Place all boxes received in the Receiving Dept. and determine the Purchase Order(s) that support the PMD received. If the Purchase Order is not enclosed in the shipment, immediately quarantine the item from further access and movement and open Bull Shark Medical Accounting Software and search by vendor for the Purchase Order and print the Purchase order and place it in the box(es) that were received.

c. Examine and physically inspect each item received for physical damage, expiration dating and for any recalls or possible breaches of quality or product integrity. If the PMDs come in their own box, take the PMD out of the box and compare the description, expiration date and lot# to the box unless the PMD is factory sealed. Examine plastic blister packaging for cracks or holes; examine paper packaging for discoloration, rips, or tears. Confirm the part number, the dating, and the quantity of the PMD to the description, the dating and the quantity on the Purchase Order. Log each lot number on to the Purchase Order. Mark the Purchase Order with a blue or black pen noting that the item and quantity was received.

d. Once the Purchase Order has been completed, log your initials and date on the top of the Purchase Order and file the Purchase Order with the Shipping/Receiving Manager.

Data Integrity

Although not required within the FDA best practices, Bull Shark Medical exceeds requirements by voluntarily tracking and recording lot numbers. Bull Shark Medical’s inventory system tracks Expiration, Product Number, and LOT number. This real time fulfillment system guarantees accurate order completion.

Bull Shark Medical data is kept offsite in a top-of-the-line data center that provides enterprise-class scale and reliability. Bull Shark Medical data is protected by encrypted communications and backups, firewalls, and multilayer access controls. In addition, Bull Shark Medical data is automatically scanned using enterprise-class anti-virus technology. The Bull Shark Medical server backs-up data each night and retains it for 90 days.

Storage Requirements

Product is separated by vendor and category and stored using the industry standard in healthcare product storage. All products are stored off the ground on shelving and suitably spaced for proper cleaning and inspection. All expired, rejected, damaged, recalled, and/or returned medical devices are immediately removed from inventory and destroyed.

Temperature

Once products are logged into the tracking software and shelved, a daily temperature monitoring system is implemented to safeguard the product against humidity and temperature fluctuation. The storage facility temperature requirements are maintained in the temperature range of 68 – 72 F.

Sanitation of Facility

A cleaning log is maintained to ensure that the storage facility is cleaned on a daily basis. No smoking, eating, or drinking is permitted in areas used for storage and handling. The storage area is designed and equipped to prevent the entry of insects and other pests.

Exposure to Outside Elements

The storage facility is designed to protect products from water infiltration as well as sunlight exposure. The packing zones as well as the receiving dock are isolated from the storage facility to eliminate unwanted exposure.

Expired Product Control / Stock Rotation

To ensure highest quality practices, Bull Shark Medical has implemented a monthly expired pull. The system directs which products are close to its expiration date and are pulled before expiration to maintain a proper stock rotation and a high level of product control.

Shipping and Delivery

Bull Shark Medical utilizes FedEx Ship Manager which is synced with the system to provide a high level of quality control and a quick turnaround time. The shipping options can be selected during check-out/order fulfillment.

Customers who prefer to be billed directly will be asked to provide a FedEx account number (the customer is responsible for all fees/charges associated with this option). Bull Shark Medical does not charge a handling fee.

Bull Shark Medical’s fully integrated system allows us to ship all orders received by 5:00PM Eastern Standard Time the same day with some exceptions. Bull Shark Medical does not assume responsibility for delays in shipping due to orders received after 5:00PM Eastern Standard Time.

All order are packaged with care and Bull Shark Medical utilizes a Pack/Verify process that ensures all orders are picked correctly. To ensure high quality Bull Shark Medical follows the proper provisions which include:

1. Product is protected from unacceptable heat, cold, light, moisture.

2. Product is not contaminated.

3. Product is properly identified.

4. Product is securely packed.

5. Product is shipped with a packing slip and the proper carrier labels.
Upon request, a tracking number can be sent to the customer for order tracking and/or record keeping.

Product Recalls

Bull Shark Medical closely monitors products for recall. In the event of a recall, the product is identified, pulled from inventory, and destroyed. When recalls are identified, Bull Shark Medical immediately contacts appropriate parties.

Recall alerts are often received from our customers who in turn voluntarily pass on the information and are also monitored by our internal Inventory Operations Department via the FDA MAUDE (Manufacturer and User Facility Device Experience) Database:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

Bull Shark Medical advanced inventory tracking system triggers a warning message if an item scanned is on our recall database table in the Enterprise Resource Planning (ERP) system. The customized automated process interlinked with our Warehouse Management System (WMS) and ERP systems helps us manage and control our recalls more efficiently.

Item(s) purchased that are subject to a voluntary or involuntary recall from a manufacturer or FDA will be replaced with an identical product not under the recall at no charge. If supply is not available, Bull Shark Medical will issue a refund.

Product Returns/Return Goods Authorization

If you have questions with your order, simply call or Email Customer Service and we will assist you in resolving any issues.

Phone: (727) 940-9405

Email:  Sales@BullSharkMedical.com