A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as, that is, substantially equivalent to, a legally marketed device that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims.510(k)
- Death - Report if the patient's death is suspected as being a direct outcome of the adverse event.
- Life-Threatening - Report if the patient was at substantial risk of dying at the time of the adverse event or it is suspected that the use or continued use of the product would result in the patient's death.
- Hospitalization (initial or prolonged) - Report if admission to the hospital or prolongation of a hospital stay resulted because of the adverse event.
- Disability - Report if the adverse event resulted in a significant, persistent, or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities or quality of life.
- Congenital Anomaly - Report if there are suspicions that exposure to a medical product prior to conception or during pregnancy resulted in an adverse outcome in the child.
- Requires Intervention to Prevent Permanent Impairment or Damage - Report if you suspect that the use of a medical product may have resulted in a condition which required medical or surgical intervention to preclude permanent impairment or damage to a patient.
When FDA review is needed prior to marketing a high-risk medical device, FDA will "approve" the device after reviewing a premarket approval (PMA) application that has been submitted to FDA.
To acquire approval of a device through a PMA application, the PMA applicant must provide reasonable assurance of the device’s safety and effectiveness.
When FDA review is needed prior to marketing a moderate or low risk medical device, FDA will "clear" the device after reviewing a premarket notification, otherwise known as a 510(k) (named for a section in the Food, Drug, and Cosmetic Act), that has been filed with FDA. To acquire clearance to market a device using the 510(k) pathway, the submitter of the 510(k) must show that the medical device is "substantially equivalent" to a device that is already legally marketed for the same use.
An independent double-check involves two clinicians separately checking (alone and apart from each other, then comparing results) the infusion settings in accordance with the physician’s order.
INSULIN INFUSION PUMP
An ambulatory electromechanical pump typically used to deliver insulin to patients with diabetes. The pump is used mainly by home care patients, but may also be used in a healthcare facility.
Manufacturer and User Facility Device Experience Database. MAUDE data represent reports of adverse events involving medical devices. The data consists of all voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996.
PATIENT-CONTROLLED ANALGESIA (PCA) INFUSION PUMP
An infusion pump intended for the delivery of analgesics (pain relievers), which is equipped with a feature that allows for additional limited delivery of medication upon patient demand.
Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, that are of substantial importance in preventing impairment of human health, or that present a potential, unreasonable risk of illness or injury.
Sometimes a company discovers a problem and recalls a product on its own. Other times a company recalls a product after FDA raises concerns.
Total Product Life Cycle (TPLC) is an integrated device review, tracking, reporting and compliance scheme employed by FDA. The TPLC approach allows FDA to integrate all regulatory activities from device inception to obsolescence.
Safe and effective use of a medical device means that users do not make errors that lead to injury and they achieve the desired medical treatment. If safe and effective use is not achieved, use error has occurred. Why and how use error occurs is a human factors concern.