MEDICAL DEVICE RECALLS

Defective medical devices(medical equipment) are subject to recall in the U.S., and the FDA Enforcement Report regularly publishes data on such recalls. For example, a total of 230 medical device-related recalls were made from 1980 to 1982. They were categorized into nine problems areas: defects in material selection and manufacturing, faulty product design, contamination, mislabeling, radiation (X-ray) violations(x ray protection), electrical problems, defective components, misassembly of parts, and no premarket approval and failure to comply with good manufacturing practice.

The first four categories, i.e., defects in material selection and manufacturing, faulty product design, contamination, and mislabeling, accounted for 70% of the recalls. The components of the defects in material selection and manufacturing classification included manufacturing defects, inappropriate materials, and material deterioration.

The subcategories of the faulty product design classification were alarm defects, premature failure, electrical interference, potential for leakage of fluids into electrical components, potential for malfunction, etc. The elements of the contamination category included defective package seals, other package defects and nonsterility. There were four subcategories of the mislabeling category: incomplete labeling, misleading or inaccurate labeling, inadequate labeling, and disparity between label and product. Similar information on other medical device recalls is available from the FDA.