Use of Registries in Product Safety Assessments

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Once a drug or device is approved for use by a regulatory authority, the product is generally use by larger and more divers populations than are typically studied in the clinical trials leading up to approval.

Medical devices in the United States have differeent surveillance programs from those for drugs.  The MEDICAL DEVICE QUALITY SYSTEMS MANUAL which was published by The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), develops and implements national programs to protect the public health in the fields of medical devices and radiological health.

These programs are intended to assure the safety, effectiveness, and proper labeling of medical devices, to control unnecessary human exposure to potentially hazardous ionizing and non-ionizing radiation, and to assure the safe, efficacious use of such radiation.

The Safe Medical Devices Act of 1990 requires that high risk medical devices be tracked after marketing and that product corrections and removals be reported to FDA if actions were taken to reduce health risks. 

Most medicl device safety tracking is accomplished through reports sumitted to FDA from medical facilites when devices are implanted or explanted.  In additon, hospitals, nursing homes ambulatory surgery centers and outpatient treatment facilites are requried to report to FDA whenever they believe that a device caused or contributed to the death of a patient.

The role of registries as one of the available tools for enhanced understanding of product safety through advers event detection and evaluation.  The legal obligations of regulated companies is spelled out in the CDHR's MEDICAL DEVICE QUALITY SYSTEMS MANUAL.

In a blog written by Business Intelligence Solutions the obligatons of regulated companies are spelled out in a recent blog article. 

The reporting process starts with a complaint. All FDA regulated manufacturers are responsible for documenting complaints against the product and evaluating them for reports. Technically, a communication would be considered as “complaint” only if alleged some “deficiencies in the product identity, quality, durability, consistency, security, efficiency, or performance of a product or device after it is released for distribution” (21 CFR Part 820).

Practicle and operational issues with reporting adverse events from registries involves the systematic collection of data from a diffused and diverse sources such as patients, potential events, diseases and medicines. 

Registries and other prospective dat collection approaches have the advantage of incorporating both health care provider and patient reproted data. 

Outcomes Information for Decision making

For clinicians and patients, outcomes research provides evidence about benefits, risks, and results of treatments so they can make more informed decisions. One group of researchers, for example, studied the outcomes of patients with pneumonia, a common cause of hospitalization in elderly people.

They developed a way for clinicians to determine which patients with pneumonia can be treated safely at home, an option that not only reduces Medicare costs but is preferred by many patients. In areas such as cancer, where outright cure is often not the only goal, outcomes research has provided the information to help patients make choices that will improve their quality of life.