Palm Harbor Medical Quality Policy
Palm Harbor Medical is a reseller/distributor of unused Prescription Medical Devices ("PMDs") used in surgical facilities, hospitals, and doctor's offices. Palm Harbor Medical purchases its inventory from a variety of suppliers, including hospitals, surgery centers, medical device distributors and other resellers. Palm Harbor 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 Palm Harbor 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.
Palm Harbor 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.
Incoming Medical Device Process:
Palm Harbor Medical currently enforces the following protocols to ensure the safety and efficacy of secondary market ("PMDs") within the market:
1. When purchasing PMDs from Palm Harbor 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 Palm Harbor 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 Palm Harbor Medical require the following documentation:
a. A purchase order addressed to Palm Harbor Medical for the merchandise. The purchase order must show the customer's name and full business address.
b. All Palm Harbor Medical sales are concluded with an invoice.
c. Palm Harbor Medical invoices clearly show Palm Harbor Medical's federal tax identification number.
d. All Palm Harbor Medical invoices must be paid by company check or cashier’s check made payable to Palm Harbor Medical. Wire transfers and major credit cards are also accepted.
Quality Control Procedures:
Receiving procedures for PMDs- Palm Harbor 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 Palm Harbor 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 Palm Harbor 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. Scan product bar codes and make sure that all relevant product information matches the blister pack and box. 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. Compare the lot numbers to our known database of recalled products and quarantine any devices that are subject to a recall. If recall products are confirmed then contact the vendor for proper disposal of the device(s). Examine and physically inspect each item received for physical damage, expiration dating and for any recalls or possible breaches of quality or product integrity. 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. Send scanned lot numbers to our database and copy and paste 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 Protection Policy:
Although not required within the FDA best practices, Palm Harbor Medical exceeds requirements by voluntarily tracking and recording lot numbers. Palm Harbor Medical’s inventory system tracks Expiration, Product Number, and LOT number. This real time fulfillment system guarantees accurate order completion.
Palm Harbor Medical data is kept offsite in a top-of-the-line data center that provides enterprise-class scale and reliability. Palm Harbor Medical data is protected by encrypted communications and backups, firewalls, and multilayer access controls. In addition, Palm Harbor Medical data is automatically scanned using enterprise-class anti-virus technology. The Palm Harbor Medical server backs-up data each night and retains it for 90 days.
Proper 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.
Cleanliness 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.
Warehouse Description:
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.
Stock Rotation:
Since we sell single use sterile disposables you use once and typically throw away nearly all devices have expiration dating. Due to the challenges regarding stock rotation and expiration dating Palm Harbor Medical has implemented a monthly short dated / 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:
Palm Harbor Medical utilizes FedEx and UPS Ship Manager through our accounting system which is synced 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 or UPS account number and the customer is responsible for all fees and charges associated with this option. Palm Harbor Medical does not charge a handling fee.
Palm Harbor Medical’s fully integrated system allows us to ship all orders received by 5:00PM Eastern Standard Time the same day with some exceptions. Palm Harbor Medical does not assume responsibility for delays in shipping due to orders received after 5:00PM Eastern Standard Time.
All orders that are packaged utilize a Pack and Verify process, by two different individuals, that ensures all orders are picked correctly. To ensure high quality Palm Harbor Medical follows the proper provisions which include:
1. Product is protected from unacceptable heat, cold, light, moisture.
2. Product is suitable for any surgical environment or reprocesser.
3. Product is properly identified and in the original OEM packaging.
4. Product is securely packed 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:
Palm Harbor 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, Palm Harbor 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
Palm Harbor Medical advanced inventory tracking system compares lot numbers with known recall products and triggers a warning message if an item scanned.
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, Palm Harbor 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: (800) 301-5376
Email: Sales@PalmHarborMedical.com
