Protecting Patients and Limiting Risk: FDA and Manufacturers' Pro-Active Response

The medical technology industry and the FDA are committed to providing patients and doctors with the safest and most effective medical technologies. We have the mutual goal of improving patient care and helping people live longer, healthier, more productive lives. Even with the enormous precautions taken to safeguard patients, problems with advanced medical technologies can, and will, happen. If there is a problem, a step-by-step system is in place to address the issue as quickly and effectively as humanly possible. Upholding patient safety and improving patient lives always comes first.

Safety is Serious Business

We're in the business of helping physicians enrich patients' lives. And although they are rare, reports of problems with medical technologies do sometimes occur.

When companies hear of them from doctors, hospitals or directly from patients, they take swift and responsible action.

Reported problems — and the appropriate response — can vary widely depending on factors like the type of product and the potential health risk posed. In most cases, the problems affect a very small percentage of devices; only rarely do they pose a serious risk to public health.

Sometimes a product must be returned to the manufacturer to be repaired, other times it can be corrected in the field. In other cases, devices can be recalled before they ever reach patients.

A Formal Recall Process Keeps Patients Safe

Of the millions of patients worldwide who benefit from advanced medical technologies each year, a very small percentage of these will ever face a health risk as a result of a product recall. When events warrant, FDA regulations outline detailed step-by-step procedures for manufacturers to follow in conducting timely, complete recalls.

These include: performing an evaluation to determine the health risk posed by the product; developing a strategy to complete the recall; and periodically submitting recall status reports to the agency.

If it is determined that a medical technology may pose a risk to public health, either the manufacturer (in over 99 percent of cases) or the FDA can have the product removed from the market.

The Recall Process Keeps Actions Proportionate

FDA has classified a range of actions as recalls - from simple labeling changes to production corrections. These recalls are risk-based and classified into one of three categories:

• Class I recalls are situations that may pose a serious health risk to patients. In these situations, medical technology manufacturers have 24 hours to issue a press release (usually written by the FDA) and alert the public.

• Class II recalls are situations where adverse health consequences are temporary or medically reversible or that pose a remote chance of adverse consequences.

• Class III recalls are not likely to pose any health risk.

Manufacturers Take Safety Seriously

Our mission is to help physicians enrich patients' lives. When problems do occur, we work quickly and closely with regulators to determine the best course of action.

Manufacturers are required by law to report to FDA when they initiate a recall for a problem that poses a risk to patients' health (Class I and Class II). Many companies go beyond this requirement and voluntarily report the least serious (Class III) recalls as well.

Our industry takes a pro-active approach to safety, which is why over 99 percent of recalls are voluntary and initiated by the company.

AdvaMed Supports Swift Notification

Patient safety begins with effective communication. That's why AdvaMed and its members stay in close contact FDA to determine the most effective method for alerting the public and health care professionals in cases of serious adverse events involving medical technologies.

-July 2005