The FDA says the number of recalled medical devices doubled from 604 in 2003 to 1, 190 in 2012. Class I recalls, the most serious, rose from 7 in 2003 to 57 during that period.
While that overall 97% increase seems astronomical, Steve Silverman, director of the FDA medical device center’s office of compliance, told The Wall Street Journal that the rate of recall lags industry growth.
Growing Device Market
U.S. medical device expenditures reportedly climbed by 112% from $73.7 billion in 2001 to $156.3 billion in 2010. The number of medical devices on the market grew by 25% from 2008 through 2012 alone.
FDA Report
The FDA, in a report titled: “Medical Device Recall Report, ” attributes the increased number of recalls in part to improved reporting by vendors and to government and industry efforts to improve performance of devices with a history of problems, such as ventilators, infusion pumps and external defibrillators.
According to the report, device design, software and non-conforming material or component issues are the most common reasons for recalls. The FDA says that as many as 400 recalls each year might be prevented if government and vendors would work together.
Industry Segment Culprits
Two specific industry segments account for the majority of the observed increase in the number of FDA-classified recalls that occurred during the study period:
- Manufacturers of radiology devices; and
- Manufacturers that receive 21 CFR 806 observations following FDA inspections.
Procodes identify the generic category of a device for FDA and is based upon the medical device product classifications designated under 21 CFR Parts 862- 892. There are over 6, 000 procodes. The most frequent device procodes for Class I recalls were:
- FRN PUMP, INFUSION
- MKJ AUTOMATED EXTERNAL DEFIBRILLATORS
- CBK VENTILATOR, CONTINUOUS
- NBW SYSTEM, TEST, BLOOD GLUCOSE, OTC
- DYB INTRODUCER, CATHETER
- LKK PUMP, INFUSION, IMPLANTED
Most of the Class I recalls were in the anesthesia, cardiovascular, chemistry, and general hospital specialties. The radiology, orthopedic, general hospital, and cardiovascular areas had the most Class II recalls.
Ortho Shines
The only orthopedic device that made it into the top ten of procodes recalls was:
- 96 JWH PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
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