In 1997, the combined number of U.S. and non-U.S. medical device firms was 9,061. Last year, there was a more than 50% increase to 13,701. And that figure is set to grow to about 15,000 firms by 2003, according to the new Performance Plan 2002, issued last month by the FDA's Center for Devices and Radiological health (CDRH). These are just a portion of the interesting statistics offered in the plan and demonstrating the uphill task that lies ahead for the FDA.
Besides offering those statistics, the Performance Plan lays out a "scorecard" approach to dealing with its current responsibilities and describes a variety of new responsibilities that have been handed to it — tasks that must be carried out with few additional resources, according to CDRH. These new responsibilities include the development of 20 "new or enhanced standards" to use in application reviews, implementation of "emergency counterterrorism preparedness and [a] response plan for radiation" and beginning the development of radiation standards for "the safety of novel or new technology used to scan people in airports and other places."
The current tasks already are formidable. They include overseeing and regulating 10,000 mammography facilities and 4,000 radiological health firms, plus oversight of the activities of 15,000 "active clinical investigators." Using the new scorecard approach, the plan says that CDRH needs improvement in four of six areas.
It rates device inspection, device post-market surveillance and radiation safety as "Not Working Well" and regulatory science as "Working but Facing Challenges." The two areas rated as "Working Well" are device review and mammography. In the area of device review, the agency reports exceeding its 2001 goal of completing 95% of premarket approvals (PMAs) and PMA supplements within the statutory 180 timeline. CDRH said it is not meeting its goal of completing 100% of 510(k) applications within 90 days, but is coming close, missing it by just 5%.
Perhaps most interesting is the formidable challenge of addressing and meeting new or revised performance goals. For example:
The CDRH set a 2003 goal of reviewing all diagnostic test devices and test kits that "detect or measure bioterrorism agents like anthrax in humans that are being marketed within the U.S." The challenge: "Currently there are no approved commercial diagnostics for this purpose, and FDA is working with industry on applications."
In the area of developing new protocols, one specifically cited is for cleaning medical devices "after use but prior to sterilization." The challenge: the FDA does not have the personnel to do all of the standards and so must work with other groups to develop protocols.
CDRH is attempting to fully implement the Medical Device Surveillance Network (MeDSuN) system for improving the reporting of adverse events, with the center estimating up to 300,000 deaths or injuries each year as the result of those events. The challenge: The FDA had originally set a performance goal of developing the MeDSuN system in 125 facilities but has revised that downward to 80 facilities, citing "concerns and problems with development timing, unanticipated program changes, and increased information technology security requirements."
CDRH said it is seeing "a resurgence of problems in both the medical and radiological product area" and that the FDA "is extremely concerned because the overexposure of children or small adults during computed tomography procedures can easily go unrecognized since medical personnel cannot simply tell that a patient has been over exposed." It also "monitored cases of unnecessary radiation emitted during fluoroscopy" and it has seen radiation-induced skin burns as an instance of "an old radiation issue."The challenge: CDRH says that its radiological health resources have continued to drop from 400 FTE (full-time equivalent staff) in FY1978 to fewer than 50 FTEs in FY2001.
An obviously "hot" new goal is in updating the agency's response plan for dealing with radiation contamination in order to respond to incidents such as the Three Mile Island nuclear power plant. The challenge: The plan indicates that this can be done only partially because the CDRH's resources in this area "have been severely reduced in past years, and the requested increase for counterterrorism funds will not be enough to fully staff the radiation emergency response teams."
Even more specifically related to the terrorism threat is CDRH's new responsibility to monitor the increased use of security scanners at airports and other security systems, with the added use of security scanners increasing the radiation exposure risk. The challenge: The health effects of expanded use of people scanners haven't been adequately tested, and standards need to be set for their safe use. While the FDA is responsible for working with other agencies to set radiation safety standards, but, the report says, "FDA does not have enough resources to aggressively conduct extensive testing in this area, and must work with the other stakeholders."
Foot problem/amputation link critical
Seeking appropriate care for foot problems associated with diabetes is critical for the avoidance of lower-extremity amputations, according to experts presenting at the late-February annual meeting of the American College of Foot and Ankle Surgeons in Los Angeles, California. "Unfortunately, many of these patients [with diabetes] eventually must undergo lower extremity amputations as a result of infection brought on by untreated foot ulcers," said Troy Boffeli, DPM. Some 2.4 million diabetes patients, representing 15% of the estimated 16 million Americans afflicted with the disease, will develop a serious foot ulcer during their lifetime. Ulcers and other foot complications are responsible for 20% of the nearly 3 million hospitalizations every year related to diabetes. Up to an estimated 45% of all non-traumatic amputations in the U.S. are the result of diabetes, with a variety of surgical and non-surgical approaches used to treat foot ulcers, Charcot deformity and other diabetes-related foot problems.
According to Boffeli, about one-third of all diabetic ulcers occur underneath the big toe (hallux), are very difficult to heal and difficult to prevent from recurring. "Diabetic foot ulcers are caused by repetitive stress precipitated by the loss of nerve sensation in the extremities," he said. "Our study shows the important role that mechanical factors play in the development of ulcers. What we have learned is that two structural complications of diabetes, a tightened Achilles tendon and limited joint motion of the first toe, are largely responsible for ulcers in the hallux area."
Boffeli explained that a thorough assessment of mechanical problems is necessary for successful treatment and prevention of hallux ulcers in diabetic patients. "Most of the patients in our sample hadn't had their feet examined in the past year, didn't wear appropriate footwear, and only a few wore any type of insole," he said. "Patients and their physicians, therefore, must be more vigilant in dealing with underlying structural causes if they are to prevent ulceration and eventual amputation." He added that strict attention to biomechanics should clarify which surgical procedures are appropriate for each patient and when surgery is indicated. Treatment and prevention should attempt to correct, eliminate or accommodate these abnormalities. Key symptoms to watch for are loss of sensation in the feet and for Charcot deformity, the foot becoming hot, painful and swollen. The results: balance is affected, bones become soft and prone to fractures, and fractures heal incorrectly and create bony deformities.
Lawrence DiDomenico, DPM, reported on studies indicating that surgery to resect deformed bones in the mid-foot area and stabilize them in a more optimal position with screws and plantar plates is proving effective in restoring foot functionality. "The accepted first-line treatment for Charcot deformity has been to immobilize the foot in a cast or brace until it stabilizes, but the patients in our study had disabling deformities and severe instability that did not respond to non-surgical treatment," DiDomenico said. "We showed, in these patients, that using a plantar plate and screws provided a more stable structure than a simple fusion using surgical screws. The outcomes indicate that patients can be ambulatory relatively soon and the procedure is a viable alternative to debilitating and costly amputations," he added.
Uterine fibroid treatment not well known
While two-thirds of American women are generally knowledgeable about uterine fibroids — benign tumors that are one of the most common medical conditions experienced by women ages 35 to 50 and a leading cause of hysterectomy — only 1% of those women know about a significant development treating them, according to a recent national survey of women released by the Society of Cardiovascular & Interventional Radiology (SCVIR; Fairfax, Virginia). Called uterine fibroid embolization (UFE), the treatment gives women an important, minimally invasive treatment option to hysterectomy and other invasive surgeries, with less risk and less pain.
UFE is performed by interventional radiologists, who specialize in targeted, image-guided treatments. By blocking the blood flow to the fibroids and causing them to shrink, the treatment is approximately 90% successful in alleviating the heavy bleeding and painful periods that are associated with them. "Uterine fibroid embolization is giving women choices," said James Spies, MD, vice chairman, department of radiology at Georgetown University Hospital (Washington).
Hysterectomy, a surgical procedure performed by gynecologists to remove the uterus, has been the predominant therapy for fibroids. Of the women who said they were familiar with uterine fibroids, 62% correctly identified one or more of its symptoms and 62% identified surgery or hysterectomy as the treatment for fibroids. Uterine fibroid embolization was named by only 1%, however. In part because of that statistic, SCVIR, which holds its annual meeting in Baltimore, Maryland, early this month, has launched a campaign to inform women about their options.
"Most women with symptomatic fibroids are candidates for UFE and should obtain a consult with an interventional radiologist to determine whether UFE is a treatment option for them," said Dr. Robert Vogelzang, chief of interventional radiology at Northwestern Memorial Hospital and professor of radiology at Northwestern University Medical School (Evanston, Illinois). "Because it is minimally invasive, it involves less risk, less pain and a shorter recovery time than open surgical procedures."