Medical Products Manufacturing

Manufacturers across the country are identifying ways to use their capabilities and systems to help meet the overwhelming need for medical products, such as face shields, gowns, masks, gloves and disposable items, and medical equipment like ventilators.

However, companies that begin producing medical products or equipment – without taking preventative action and seeking adequate protection and legal counsel – have the potential to face significant legal and product safety exposures.

Consider these important questions before manufacturing medical products or equipment outside of your normal scope of operations and consult your independent insurance agent to discussion specifics of your plans.

General Medical Products

Was a formal design analysis – by an engineer with medical manufacturing experience – performed to evaluate all potential hazards before production begins?
Has a thorough review of your raw material and component part suppliers – including internet research, reference evaluation and written contract review – been conducted?
Are you using raw materials or component parts designed to be used with the product? Defective raw materials and components can cause product failure or defect.
Have you obtained contractual indemnification from your raw material and component parts suppliers?
What type of formal manufacturing quality controls or systems are in place? In short, how good is the quality management system?
What warnings or instructions are provided with the product?
What kind of product traceability controls are in place? Serial numbers, or another tracking mechanism?
Who are your customers? Are they sellers or medical facility end users?
Have you provided contact information – a toll-free number or email address – so your customers can reach out with questions, needs or product-related concerns?
Is a tracking, safety or procedural mechanism in place for tracking product safety?
Have you reviewed if any intellectual property exposures are associated with manufacturing and distributing of the product?
Do the changes required to manufacture this new product present additional fire-related exposures to your facility and its occupants? For example, are you now storing more or different flammable liquids, plastics, textiles and lumber?
Was the current fire protection system designed with capabilities sufficient for the potential risks presented by the new storage occupancy?

Ventilators

Continuous ventilators are a Class 3 medical device regulated by the FDA and must meet special requirements. Class 3 devices have a high risk to the patient and usually sustain or support life, are implanted or present unreasonable risks of illness or injury. Companies choosing to manufacture ventilators must comply with FDA requirements. In addition to the questions above that apply to the production of general medical products, review these questions and resources:

Was the formal design analysis performed by an engineer with Class 3 medical device manufacturing experience?
Is there a formal procedure in place for reporting serious ventilator safety issues to the FDA?
The FDA has published references you can review when considering the production of ventilators:

Please contact your independent agent with questions for your Cincinnati loss control representative or to discuss possible changes to your operations. Thank you for trusting your agent and Cincinnati to protect your business.

Our loss control service is advisory only and should not be interpreted as legal advice. This list is not intended to be all-inclusive, nor will every exposure or control listed apply to each risk. We assume no responsibility for management or control of customer loss control activities nor for implementation of recommended corrective measures. The information on this page was compiled from sources believed to be reliable for informational purposes only. All sample policies and procedures herein should serve as a guide only, used to create your own policies and procedures. We do not warrant that requirements of any federal, state or local law, regulation or ordinance have or have not been met, nor that compliance with any or all of the recommendations stated herein will guarantee coverage under any specific factual scenario.

Changes to your operations may impact coverage under your insurance policy. We do not warrant to have identified all hazards. We do not guarantee the accuracy of the information contained herein, and disclaim any liability arising out of reliance on information contained herein.