Provider Strategy

Seven Principles for Being Prepared

Reducing risk is smart business and smart care.

• By Gretchen Schuler
• Aug 01, 2011

As the number of individuals using home medical equipment continues to increase, so does the potential for injury, property damage and litigation. Is your business prepared? Do you have procedures in place to minimize your exposure now that you have more products in patient’s homes? Do you have adequate insurance? Are you buying from manufacturerswho have insurance?

It is imperative that manufacturers and providers work together to ensure patient and business protection. Risk Management is not just for the insurance companies; it touches us all. The following are “best practices” to help you improve patient safety, reduce risk and assist in the investigation of claims/litigation.

1. Maintain Complete Patient Records
Ensure that your patient records include information regarding the services/products provided to the user; detailed maintenance/service records; product identification such as model, serial numbers and date codes; and written confirmation (i.e. user’s signature) that the written literature was provided to the user. Being thorough up-front will make certain you are prepared for the future.

2. Educate the Patient
Always give the user all the written instructions/warnings provided by the manufacturer, and have the user sign to confirm receipt of written materials/warnings (especially NO SMOKING warnings with oxygen equipment and Bed Rail Entrapment Awareness Information). If you know that the consumer is going to use the product in a manner not intended by the manufacturer, you have the duty to warn them against such actions.

If you need another copy of the manual/instruction sheet, most manufacturers have this available on their websites or through customer service.

3. Provide the Appropriate Product for the Patient
Always provide the appropriate product for the user (i.e. a product within weight capacity, appropriate for physical needs, etc). Also, do not modify/alter the product. Having the best fit and equipment can make all the difference in a patient’s daily life and we are the means to attain that.

4. Handling Allegedly Defective Products
If you have what you believe to be a defective product or a product involved in an alleged incident involving injury or property damage, retain it and contact the manufacturer as soon as possible. Take photos of the product and accident scene, if relevant and possible. In cases of alleged injury or property damage, many manufacturers have the capacity to store such items in anticipation of litigation so that you do not have to quarantine the product in your warehouse or office.

5. Industry Knowledge
Stay current with issues pertaining to the medical device industry and pass along that information to your customers. In addition to trade publications, there are a number of web resources you can utilize. The FDA website at www.fda.gov has a plethora of information regarding medical device equipment, issues, recalls, etc. In addition, this website explains in great detail the Hospital Bed Safety WorkGroup’s (HBSW) recommendations regarding bed rail compliance, including the fact that beds should be tested as a system (i.e. same manufacturer’s bed, rail and mattress).

Manufacturers are also a good source of information. For example, the Invacare website (www.invacare.com) has a Consumer Education page with helpful articles and information for your customers and the Invacare Tech Zone has maintenance information for providers. Take advantage of any training available from the manufacturer on products, maintenance and repair.

6. Insurance
Purchase products only from manufacturers who are insured. This is important because:

• Adequate insurance coverage affirms that a company like Invacare is a good, solid manufacturer. All providers in good standing are entitled to a certificate of insurance from a manufacturer. If a manufacturer does not have coverage, there could be an adverse reason.
• It confirms that the manufacturer stands behind its products.
• Purchasing from an insured manufacturer like Invacare could positively impact a provider’s own insurance premiums, while purchasing products from an uninsured manufacturer could have a negative impact on their insurance premiums.

Always keep copies of your insurance information and the Certificates of Insurance from the manufacturers from whom you purchase, and keep them in a safe and common place so you can refer to them easily, if necessary.

7. Tender of Defense Requests in Litigation
Should you get sued, the following issues will likely lead to a manufacturer’s denial of a tender of defense request should your business become involved ina claim or lawsuit:

• Modifications of the product contrary to the manufacturer’s instructions.
• Use of non-OEM accessories and components.
• Failure to provide the manufacturer’s instructions.
• Failure to keep adequate records and document the product identification information.

With a focus on improving patient safety, reducing risk and participating in the investigation of claims, manufacturers and providers together can both improve patient care and the strength of our businesses. The right preparation and foresight can adequately prepare your business to minimize risk and offer your patients the best care possible

This article originally appeared in the August 2011 issue of HME Business.