Quality Assurance & Control Program
Valley Surgical is a redistributor of surgical supplies to healthcare facilities and relief organizations throughout the United States. Valley Surgical partners with hospitals and surgery centers to assist them in recovering monies spent on Prescription Medical Devices (“PMDs”) by purchasing their in-date, unused, surgical disposable inventory. On the other hand, Valley Surgical provides supplemental cost-savings to hospitals and surgery centers who are sourcing and purchasing these same PMDs to lower their med/surg spending.
Though companies like Valley Surgical are not regulated by the Food and Drug Administratoin (“FDA”), to comply with the FDA’s regulatory decisions to limit the tracking, registration and listing requirements for distributors of PMDs, Valley Surgical adheres to a Quality Assurance & Control Program that includes specific sourcing, selling, and quality control best practices.
These best practices were designed to significantly reduce the likelihood that Valley Surgical could unintentionally purchase products from a seller that could not demonstrate its legitimate ownership. Valley Surgical purchases inventory from licensed facilities, including hospitals, ambulatory surgery centers, and medical device distributors.
The best practices that are implemented include the following:
- Restrictions on eligible vendors;
- Required paperwork for all transactions including signed purchase offer, and invoice;
- Quality control procedures to ensure the maintenance of safety and efficacy upon receipt, storage and distribution.
Valley Surgical’s warehouse team follows strict quality control processes to assure product integrity and accuracy. The company’s facility is a climate controlled, hygienic warehouse and monitored 24 hours with video / security surveillance. Valley Surgical 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. Valley Surgical distributes inventory of surgical disposables to integrated delivery networks, community and rural hospitals, medical universities, as well as ambulatory and same-day surgery centers on a daily basis that trust in the quality of product provided.
Quality Control
Valley Surgical’s staff follows strict guidelines when receiving and shipping surgical supplies:
I. Upon receipt, each item is individually inspected to ensure it meets quality assurance standards. Our inspection process includes but is not limited to:
a. OEM Packaging Inspection: Each item received is thoroughly checked for visual OEM package integrity. Valley Surgical carefully inspects each package to ensure that the contents accurately reflect the appropriate manufacturer product code, lot number, and expiration date. Each package is inspected to make sure that it is clear from any blemishes and/or damage.
b. Individual Product Inspection: Valley Surgical physically inspects each item to ensure that the integrity of the product has not been damaged during the shipping process.
c. Lot Number and Expiration Date Inspection: Valley Surgical inspects each unit to ensure that the product is in-date. In addition, Valley Surgical inspects and records each individual lot number to ensure the product received is not subject to recall.
d. Temperature Gauge Inspection: Upon receipt and delivery, temperature indicators that are located on climate-controlled disposables are verified to ensure product integrity.
Upon completion of the quality control process, each individual unit is logged into an advanced inventory tracking software with lot number and expiration date for strict tracking purposes.
Cleanliness
The storage facility is cleaned and free of waste 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 reception and packing areas are segregated from the storage site to eliminate unnecessary exposure.
Data Tracking
Although not required by the FDA, the Valley Surgical quality assurance program exceeds requirements by voluntarily tracking and recording lot numbers. Valley Surgical’s inventory system tracks Expiration, Product Number, and Lot number to ensure full traceability of product entering and exiting its warehouse.
Recalls
Valley Surgical 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 Valley Surgical, both voluntary from a seller and involuntary through the FDA MAUDE Database (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm) Valley Surgical 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 FDA will be replaced with identical product not under the recall at no charge. If supply is not available, Valley Surgical will give the facility equal dollar credit towards future orders.
Valley Surgical utilizes the FDA searchable recall database for all products distributed by Valley Surgical 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/ListofRecalls/default.htm
When a recall alert is received at Valley Surgical both voluntary from a seller and involuntary through the FDA 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.
Selling Protocols
Valley Surgical enforces the following “Selling Protocols” to ensure the safety and efficiency of selling PMDs 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.
- The customer may be a provider of medical services (ex. hospital, clinic, surgical center, distributor).
- 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 Valley Surgical upon request:
- A record of the purchase of the merchandise together with a copy of the invoice and evidence of payment for the merchandise.
- 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.
- 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.
- All sales made by Valley Surgical must include the following documentation:
- A purchase order addressed to Valley Surgical for the merchandise. The purchase order must bear the customer’s name and full business address.
- All Valley Surgical sales are concluded with an invoice on Valley Surgical company stationery.
- All Valley Surgical sales must be paid by company check or cashier’s check of or by the customer and the check payable to Valley Surgical. Valley Surgical also accepts wire transfers and credit cards.