Materials and Vendors Control

Any manufacturer looking to market a medical device in the United States that requires a 510(k) application (also referred to as “premarket notification”) is required to submit an application to the FDA at least 90 days before the date they wish to begin selling the device in the US market. The application should provide evidence that the device is safe and effective for its intended use.

However, if the medical device requires the more strict, Premarket Approval (PMA) application, the application will undergo an investigation and validation process by the FDA to ensure that there is valid evidence that the device is safe and effective for its intended use.

Another type of medical device application that can be submitted to the FDA is the Humanitarian Device Exemption Application (HDE). HDE applications exist so that manufacturers may obtain an exemption for humanitarian use. The application process resembles both the 510(k) and (PMA), but is exempt from proving device effectiveness.

All establishments that use medical devices, such as dental laboratories, are required to comply with the FDA and DAMAS dental material reporting policies, and the laboratory is mandated to develop a system and procedures that helps in evaluating and choosing medical device materials, suppliers, and subcontractors.

Monitoring Your Materials

The laboratory is responsible for any material used in a device that comes in contact with a patient’s mouth. A list of FDA, 501(K) and PMA approved medical device materials and products can be found on the FDA web site. The laboratory is also required to keep a log of all materials by brands and/or generic types.

To ensure that materials used in your laboratory are always in compliance, they must be strictly controlled. Controlling materials starts with establishing a purchasing system that provides specific instructions on choosing materials, suppliers, alternate suppliers, order approval processes, verification, and validation of materials received, etc.

When the laboratory receives a shipment of materials, it must be verified that the shipment matches the initial order. The materials received must also correspond with the technical specifications indicated by the purchase order.

If the material received was not-as-ordered or defective, the laboratory must issue a report detailing the defect and any nonconformity. The laboratory must then inform the supplier of the mistake, share with them the non-conforming report, and offer the supplier protocol of a specific corrective action. If the issue is minor, the laboratory may leave it to the supplier to take action that corrects the problem.

Choosing Your Supplier and Subcontractor

It is important that laboratories purchase only from qualified suppliers. According to the FDA and DAMAS regulations, laboratories must keep a list of their key and alternate suppliers for any materials they purchase regularly that come in contact with the patient’s mouth. It is also required that all suppliers undergo an annual audit by the laboratory to ensure they practice a verifiable quality assurance system and are in compliance with DAMAS quality standards.

The laboratory must also regularly identify and audit potential suppliers to find out if they qualify.

For the laboratory to conduct an audit of a supplier, it can: 1) rely on third-party certification that a supplier is in compliance, provided their certificate can be verified, 2) require non-certified suppliers to obtain certification, or 3) the laboratory can conduct its own audit to determine whether a supplier is in compliance with DAMAS required quality standards.

The laboratory purchasing system must contain specific procedures that identify who in the laboratory will be responsible for maintaining a list of qualified suppliers and how suppliers can qualify as approved vendors.

Here are some additional factors to consider if you are searching for new supplier or evaluating the performance of your current one:

Does the supplier demonstrate commitment to quality products?
Is the supplier certified?
Does the supplier maintain a policy of open communication at all costs?
Can the supplier deliver materials promptly?
Can the supplier work with you regarding special requirements and are they willing to provide technical assistance?
Does the supplier understand your market and the demands required to meet market changes?
Is the supplier financially stable and is set up to avoid stock-outs?

Progressive Improvement

The main goal of a laboratory when going through the DAMAS certification is to improve quality and customer experience. When considering the laboratory’s purchasing system, ensuring quality material inputs helps in this goal. Progressive comments on nonconformity are also crucial to the success of the system. These comments not only offer solutions to problems, but also correct the root causes that can lead to nonconformity.

One of the most important criteria to consider when selecting a supplier is whether or not they have an internal comments and response system in place that is monitored continuously. When auditing a supplier to qualify them, it is imperative to audit not only how they track the non-conforming products, but also what modifications have they implemented since the nonconformity to correct the root cause of the problem. Such a process should be a mandate and an integral part of the laboratory purchasing system. The progressive improvement comments and response loop is a requirement under DAMAS and FDA quality assurance system and good manufacturing practice.

Besides compliance with DAMAS and FDA mandated quality assurance system, controlling materials and suppliers has other advantages. Here are a few:

It ensures the availability of materials when needed and reduces production delays.
It lessens the financial burden of keeping unused or out-of-date inventory.
It creates the ability to establish a genuine purchasing policy that ensures competitive pricing.
It identifies vendors’ strengths, weaknesses, threats, and opportunities for improvement.
It ensures that vendors consistently comply with DAMAS requirements, so the non-conforming issues do not need to be addressed multiple times.

Nick Azar is a DAMAS consultant, business strategist, executive coach, and founder of Azar & Associates. For inquiries, Nick can be reached at nick@azarandassociates.com.