Quality Assurance and Service Guarantee

Surgical Product Solutions (SPS) is a solution based company that partners with healthcare facilities to recover significant budget costs by purchasing their un-used, in-date surgical surplus. At the same time, SPS provides supplemental cost savings and flexibility when purchasing high volume surgical products that customers are currently utilizing.

SPS’s focus is simple: helping customers become higher quality healthcare providers without compromise. In order to maintain a high level of integrity, Surgical Product Solutions upholds strict records and business practices when it comes to quality control, accuracy, and attention to detail.

The FDA has made a regulatory decision to limit the tracking, registration and listing requirements for distributors of medical devices. As a result, SPS institutes a compliance program that includes specific purchasing and quality control best practices. These best practices were designed to significantly reduce the likelihood that SPS could unintentionally purchase products from a seller that could not demonstrate its legitimate ownership. SPS only purchases inventory from licensed facilities, including hospitals, surgery centers, and medical device distributors. The best practices that are implemented include the following: (a) restrictions on eligible vendors; (b) required paperwork for all transactions including signed purchase offer, and invoice; (c) quality control procedures to ensure the maintenance of safety and efficiency upon receipt, storage and distribution.

In addition, SPS has established stringent quality control systems to assure product integrity & employs smart technology to assure inventory record accuracy. The company’s facility is a climate controlled, hygienic warehouse equipped with backup generators and 24 hour video / security surveillance. SPS strives to provide the best possible service through an advanced inventory tracking software that resides on enterprise-class servers in an offsite data center where data is backed up daily. SPS distributes inventory of surgical disposables to health systems, community hospitals, rural hospitals, as well as ambulatory and same-day surgery centers on a daily basis that trust in the quality of product provided.

Processes

Selling Procedures

SPS enforces the following “Selling Best Practices” to ensure the safety and efficiency of selling medical devices in a secondary market:

  • The customer must be a person or entity with authority to own the merchandise – pursuant to Title 21, United States Code.
  1. The customer may be a provider of medical services (ex. hospital, clinic, surgical center, distributor).
  • All sellers must be able to prove they have good and marketable title to the merchandise being sold and that the product being sold has been stored and maintained properly. Facilities must be willing to demonstrate to SPS upon request:
  1. A record of the purchase of the merchandise together with a copy of the invoice and evidence of payment for the merchandise.
    1. The record 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.
    2. An inventory control sheet of the seller printed on the stationery of the seller from whom the merchandise was purchased and bearing all marks typical of such documents - such as inventory control numbers, storage locations, purchase dates, manufacturer name, expiration dates.
  • 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.
  1. All sales made by SPS must include the following documentation:
  1. A purchase order addressed to SPS for the merchandise. The purchase order must bear the customer’s name and full business address.
  2. All SPS sales are concluded with an invoice on SPS company stationery.
  3. All SPS sales must be paid by company check or cashier’s check of or by the customer and the check payable to SPS. SPS also accepts wire transfers.

Quality Control

To ensure product integrity, SPS has dedicated procedures for a thorough receipt and delivery process:

  1. Upon receipt, each unit is individually inspected to ensure it meets quality assurance standards. Our inspection process includes but is not limited to:
    1. Visual Package Integrity Inspection: Each unit is checked for visual OEM package integrity. SPS carefully inspects each package to ensure that the contents accurately reflect the appropriate product code, lot number, and expiration date. Each package is inspected to make sure that it is clear from any blemishes and/or damage.
    2. Visual Product Integrity Inspection: SPS physically inspects each unit to ensure that the product has not been compromised prior to receipt.
  • Sterile Seal Inspection: SPS inspects each sterile unit to ensure that the sterile seal has not been compromised.
  1. Lot Number and Expiration Date Inspection: SPS inspects each unit to ensure that the product is in-date. In addition, SPS inspects and records each individual lot number to ensure the product received is not subject to recall.
  2. Temperature Gauge Inspection: Upon receipt and delivery, temperature indicators that are located on climate-controlled disposables are verified to ensure product integrity.
  1. Upon completion of the quality control process, each individual unit is logged into an advanced inventory tracking software with lot number and expiration date. The software provides systematical management of the Recall and an intelligent automated picking processes to guarantee complete accuracy when picking orders.

Storage Requirements

Product is separated by vendor and category using the industry standard, healthcare grade AkroBins. All product is 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 quarantined 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. SPS maintains a temperature and humidity log where storage climate conditions are measured and recorded on a regular basis. The storage facility temperature requirements are maintained in the temperature range of 68 – 72 F.

Cleanliness

The storage facility is cleaned and free of waste on a daily basis. The frequency of cleaning is recorded daily. 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 reception and packing areas are segregated from the storage site to eliminate unnecessary exposure.

Stock Rotation

To avoid product deterioration, SPS employs an automated distribution system. The inventory software directs which specific lot number / expiration date should be picked for each customer order in an attempt to maintain proper stock rotation. Unless noted otherwise, the inventory software will pick the relevant LOT number / expiration date combination to fulfill the order. The software is programmed to pick the shortest expiration date first but can be overridden upon request if longer expiration dates are required by the customer.

Data Integrity

Although not required within the FDA best practices, the SPS quality assurance program exceeds requirements by voluntarily tracking and recording lot numbers. SPS’s inventory system tracks Expiration, Product Number, LOT number, as well as package care requirements for each product. This real time fulfillment system guarantees accurate order completion.

SPS data is kept offsite in a top-of-the-line data center that provides enterprise-class scale and reliability. SPS data is protected by encrypted communication, firewalls, multi-layer access controls, and encrypted backups. In addition, SPS data is automatically scanned using enterprise-class anti-virus technology. The SPS sever backs-up data nightly and retains it for 90 days.

Recall

SPS continuously reviews products for recall. In the event of a recall, the product is identified, segregated, and destroyed.

When a recall alert is received at SPS both voluntary from a seller and involuntary through the F.D.A. MAUDE Database (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm) SPS immediately contacts appropriate parties.

For all surgical facilities, any item(s) that are subject to a voluntary or involuntary recall from a Manufacturer or the Food & Drug Administration (FDA) will be replaced with identical product not under the recall at no charge. If supply is not available, SPS will give the facility equal dollar credit towards any other device(s) in our inventory.

SPS utilizes the FDA searchable recall database for all products distributed by SPS by accessing the following publicly available FDA databases:

FDA Searchable Recall Database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

Link to RSS feeds for Email Alerts regarding Recalls http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/default.ht

When a recall alert is received at SPS both voluntary from a seller and involuntary through the F.D.A. through MAUDE Database ( http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm) we immediately load it into our system to contact our second party buyers.

Please contact SPS for instructions on returning recalled products.

Shipping & Delivery

All orders are shipped UPS Ground unless expedited shipment is requested or required. UPS Ground shipments are 2-5 day delivery. Customers who have provide or will be providing FedEx or UPS account numbers will be billed directly by the carrier. SPS does not charge a handling fee. Facilities using their own shipping accounts are responsible for the fees and under no circumstances is SPS responsible for any charges or fees. All orders ship F.O.B. – SPS

All orders after 4:30PM Eastern Standard Time will be shipped next day unless noted. SPS is not responsible for delays in shipping due to orders arriving after 4:30PM Eastern Standard Time.

Each order is packaged with care and proper provisions in such a way that:

  1. Item identifications are not lost.
  2. Items are not contaminated.
  3. Items are insulated from breakage.
  4. Items are not subjected to unacceptable degrees of heat, cold, light, moisture, or other adverse influences.

Returns & Replacements

Surgical facilities are allowed to return items upon request, including ordering errors. Any facility not satisfied with any device upon receipt will have that device replaced at no charge. If that specific product is not available, SPS will give the facility equal dollar credit towards any other device(s) in inventory. Should any product solde reach its expiration date prior to receipt of that product, SPS will replace the product at no charge and if that specific product is not available, equal dollar credit towards any other device(s) in inventory will be issued.