Articles on Law, Science, and Engineering

What Should You Report?[index]

Device user facilities should integrate form 3500 and its expansive reporting standards into their risk management and incident systems. The first step is to train in-house health care professionals to use form 3500. While form 3500 is not an ideal form, it is critical that all internal forms contain at least the information necessary to complete 3500. From a paper work perspective, using form 3500 with suitable addenda would eliminate the need to complete two forms on the same event. The facility risk manager should assure that the form is correctly completed. Rather than submitting form 3500 directly to the FDA or the manufacturer, however, the health care professionals should give the form to the facility. The facility can then use the information to complete their form 3500a, before sending all the forms to the FDA.

At this point the device user facility can either complete the form 3500a with the statutory minimum of information, or it can submit the same information as the health care professional. I believe that device user facilities should follow the guidelines for voluntary reporting by health care professions (form 3500 and its accompanying instructions), rather than file a form that contains less information than the form 3500 filed by the health care professionals involved in the event. This means reporting both suspected and certain product-related injuries. More importantly, it means reporting all potentially hazardous product problems, irrespective of whether they resulted in a patient injury. I do not believe that there is any risk in providing more than the statutory minimum information. (The FDA has provided legal protections that will prevent any reported information from being used in litigation against the user facility.) It will eliminate potentially embarrassing discrepancies between reports filed by health care professionals in the facility and those filed by the facility itself. Most importantly, it will improve general product safety by giving the FDA the necessary information to carry out its regulatory role.

"Voluntary" Mandatory Reporting