Maybe there is actually a light at the end of the tunnel for dental laboratories. Has your dental lab considered repurposing its manufacturing from dental devices to medical devices? Those dental labs that are already manufacturing medical devices can add to their production platform. This pandemic has created a shortage in not only PPE - personal protective equipment but also medical devices, accessories, and COVID-19 testing kit items such as swabs.
Here are some of the considerations that a dental laboratory owner will need to assess prior to committing to repurposing its manufacturing capabilities:
- Does this require you to register with FDA and how much does it cost?
- Has FDA issued any guidance on 3D printing of Medical Devices, Accessories, Components & Parts During the COVID-19 Pandemic?
- Do you have a Quality System in place that covers the manufacture of these new items?
- Standard Operating Procedures
- Work Instructions
- Equipment Maintenance
- Complaint system
- Tracking system for materials and devices, if required
- Is your current equipment and software cleared for this type of manufacture?
- Is the basic material, such as a resin, readily available?
- What are your customer’s requirements for packaging finished devices?
- Will you need to purchase additional types of packaging and shipping materials and are they available?
- Does the packaging size require the purchase of lifting equipment such as packaging on pallets that would require lifting equipment?
- Is your marketing making claims that could put your business at risk?
- Does the customer require any other processes besides manufacturing such as sterilization?
- Will other equipment need to be purchased?
- Will this product be covered under your current product liability insurance?
- Does the manufacturing introduce hazards that require training for your workers?
- Can you meet current physical distancing requirements for workers?
- Will this manufacturing require shifts due to physical distancing requirements and also volume of items being manufactured?
- Is there adequate space in the facility to handle the volume of production and storage until pick-up of shipments?
As you can see from the above list, there are many considerations before committing to repurposing your dental laboratory and this list is not exhaustive. If there are any new or heightened risks, then address them prior to commitment to the customer. Where possible, share and collaborate with other dental laboratories to learn if they have encountered any obstacles during this process. Also, contact SafeLink Consulting to discuss regulatory considerations and let us help you manage the safety and quality side of this venture. It could put your employees back to work and funds/grants may be available through your state or the federal government.
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Benefits of Implementing a Quality System
How to Stay on top of FDA Dental Regulations
Managing Risks of the Coronavirus in the Dental Laboratory Setting
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Managing Risks of the Coronavirus in the Dental Practice Setting
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