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Health Hazard Evaluation Essential to Recall Decisions

If a problem with a medical device crops up frequently enough or appears to be of a serious nature, the manufacturer must determine whether a recall is necessary. And the way to do that is something called a Health Hazard Evaluation. In fact, it is required under 21 CFR 7.41, said a lawyer. "There are a number of factors you have to address," said John "Jack" Garvey, Esq., vice president of compliance and quality management for The Weinberg Group. "Has disease or injury occurred due to the use of a violative product?

Could existing conditions contribute to a clinical situation that could expose humans or animals to a health hazard? How will the hazard impact various population segements? That is, it is more serious for geriatric patients? Neonates?" Garvey spoke at an MD&M West conference session. The evaluation must address the degree of seriousness to which at-risk populations would be exposed, the likelihood that the hazard will occur, and the assessment of consequences (both short-term and long-term) if the hazard of occurs. "The assessment must be done in the context of broader safety knowledge," he said. It is particularly important that financial considerations not enter in to the evaluation, Garvey emphasized. "Business determinations should not be in your recall determinations. Period." But what should be in a health-hazard-evaluation system are links to a firm's CAPA system, and perhaps even process validation records. "Well-versed investigatiors will look for a `holistic' view on product safety/CAPA/health hazard evaluation systems integration," he said. At the same MD&M West session, Michael Barile, managing partner of Barile & Associates, presented a model health-hazard evaluation form. It assigns a factor of 1 to 5 for the probability of the fault's occurrence (1 being remote, 5 being continuous). It does the same for the probability of illness or injury should the fault occur (1 being extremely unlikely, 5 being extremely likely). And also for the severity of the protential illness or injury (1 being none, 5 being life threatening.) These three numbers are then multiplied together and compared to pre-set criteria for "risk to health." These criteria should be documented in the firm's standard operating procedures on recalls. A score of 1-4 means the risk is negligible. A score of 5-9 means it is low, 10-24 means it is moderate, and 25-125 means it is high. These scores can help determine the level of the recall (Class I is the most serious, Class III the least serious), if one is necessary. -- Erik Swain

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