Policy Manual sample

MDT Home Health Care Agency, Inc. PRODUCT RECALL NOTIFICATION POLICY OBJECTIVE The purpose of this policy is to establish a responsible and effective product and medical device recall system for the protection of patients and employees, to comply with regulations, to avoid claims based on alleged negligence in response to product recalls. SCOPE: All Skilled Services DEFINITIONS 1. Recall: as defined by the Food and Drug Administration is a "firm's removal or correction of distributed products that in the judgment of the Food and Drug Administration are subject to legal action under the laws administered by the Food and Drug Administration. a. Classification of Recalls. i. Class I Recalls can be described as Urgent, Life-Threatening 1) A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious, adverse health consequences or death. ii. Class II Recalls are as serious as Class I Recalls. Corrective action is required. 1) A situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible health consequences or where the probability of serious, adverse health consequences is remote. iii. Class III Recalls, are described as Advisory. 1) A situation in which the use of, or exposure to, a violative product is not likely to cause adverse health consequences. (Emphasis added.) 2) The FDA has classified recalls into three types, based on the extent of potential harm that could result from use of the product 2. Defective Product: Examples of product problems are improper labeling, defective components, performance failure, poor packaging and erroneous information POLICY No product or device will be utilized which has been deemed by the FDA, manufacturer, Infection Control, to be a hazard or that may endanger the safety and welfare of the patient. PROVISIONS 1. The responsibility for coordinating the product recall process is centralized in the Clinical Department. a. Director of Nursing (DON, Clinical Manager) may receive notification of product recall either from the manufacturer directly, an FDA enforcement report, or internally from individual staff that have identified a product defect. 1) In the case of internally identified defective products, the DON, Clinical Manager will notify the FDA, Medical Equipment company if applicable, and Risk Management (Administration). 2) DON, Clinical Manager contacts manufacturer and completes FDA Reporting Form. b. The Administrator, DON, Clinical Manager, will subscribe to the weekly FDA L-30 Home Health Agency Client Assessments