OptiPar is an environmentally responsible reseller of unused, in-date Prescription Medical Devices (“PMDs”) used in surgical facilities, hospitals, and doctor’s offices. OptiPar uses software technology to allow a variety of healthcare supply chain facilities to sell it’s exisiting inventory in a safe and secure online marketplace. OptiPar, a reseller of PMDs in the secondary market, is not regulated by the Food and Drug Administration (“FDA”). OptiPar’s mission statement is as follow: To optimize and recapture healthcare revenue through efficient and secure healthcare supply chain. OptiPar institutes a compliance program designed to provide a commercially reasonable process to eliminate, or substantially reduce, the possibility that OptiPar could inadvertently list products from a seller that could not demonstrate its legitimate ownership. This program 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 offered by OptiPar includes specific seller protocols to validate the nature of those sellers from which OptiPar offers in their marketplace; 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 Systems Procedures to ensure the accuracy and integrity of the product. OptiPar operates as a compliant commercial enterprise and has established quality control systems.
OptiPar currently enforces the following “Sales Protocols” to ensure the safety and efficacy of secondary market (“PMDs”) within the market: 1. The customer must be a person or entity with authority to own the merchandise pursuant to Title 21, United States Code. a. The customer may be a provider of medical services (ex. hospital, clinic, surgical center). b. OptiPar does not sell any merchandise to a manufacturer’s representative/agent. 2. All sellers 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. An inventory/property control sheet of the vendor printed on the stationery of the vendor from whom you purchased the merchandise and bearing all marks typical of such documents – such as inventory control numbers, storage locations, purchase dates, manufacturer name, expiration dates. The document must be provided to OptiPar by the employee/agent of the vendor. iv. 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.
All transactions made by OptiPar require the following documentation: a. A purchase order addressed to OptiPar for the merchandise. The purchase order must show the customer’s name and full business address. b. All OptiPar sales are concluded with an invoice on OptiPar company stationery. c. OptiPar invoices clearly show OptiPar’s federal tax identification number. d. All OptiPar’s invoices must be paid by company check or cashiers check made payable to OptiPar. Wire transfers and major credit cards are also accepted.
OptiPar uses a world class Inventory Management system to track Expiration, Product Number, Vendor, Pricing, Available Stock, and LOT number. This real time fulfillment system guarantees accurate order completion. OptiPar data is kept offsite in a world class state of the art data center that provides enterprise-class scale and reliability. OptiPar data is protected by encrypted communications and backups, firewalls and multilayer access controls. In addition, OptiPar data is automatically scanned using enterprise-class anti-virus technology. The OptiPar server backs-up data each night and retains it for 90 days.
To ensure highest quality practices, OptiPar has implemented a realtime expired notification system. The OptiPar system directs which products are close to its expiration date and are flagged before expiration in order to maintain a proper stock availability rotation and a high level of product control.
OptiPar utilizes FedEx and UPS Automation systems which is synced with the OptiPar secure database system in order to provide a high level of quality control and a quick turnaround time. The shipping options can be selected during checkout/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).
OptiPar’s fully integrated system allows us to ship all orders received by 2:00PM Eastern Standard Time the same day with some exceptions. OptiPar does not assume responsibility for delays in shipping due to orders received after 2:00PM Eastern Standard Time. All orders received forwarded to the seller with specific packaging instructions. OptiPar utilizes a Pack/Verify ERP process that ensures all orders are picked correctly. Tracking numbers are automatically sent to the customer for order tracking and/or record keeping.
In the event of a recall, the product is identified, flagged in the database, and removed from an Active Status. When recalls are identified, OptiPar 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: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm OptiPar’s 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. This system 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, OptiPar will issue a refund.
Product Returns/Return Goods Authorization In the event of an order error our customers are able to return the items following the table below.
All products sold by OptiPar are in-date unless specified. Product images are for display only. Pharmaceuticals not sold to individuals. All Trademarks & Logos belong to their respective owners. OptiPar does not represent or claim any relationship to the respective companies or their equipment or products, names are used for reference only. OptiPar does not provide advice, training, or clinical support.
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support@optipar.com