The Food and Drug Administration (FDA) plays a critical role in safeguarding the health and welfare of the public. Yet recent reports by the United States Government Accountability Office reveal that severe underfunding and a lack of manpower and legal authority have seriously undermined the agency’s ability to protect American consumers. During this past year, problems with foreign-imported products such as tainted heparin and pet food—as well as faulty defibrillators—suggest that more needs to be done to protect the public from unsafe medical devices, drugs, and food.

Although these developments paint a dark picture, it is important to note that the medical equipment biomeds work with has fared much better than food items, drugs, and biologics. “If you look at the FDA notices that come out every week, the majority of the recalls or notices are on blood products,” says David Harrington, PhD, a Medway, Mass-based industry consultant and member of 24×7‘s editorial advisory board. “Most of the corrections that are required for medical devices are relatively simple and are not complete removals.”

The FDA’s policy for device approval is extremely effective in ensuring that hospital equipment is safe and works properly. Devices introduced to the marketplace prior to 1976 were never required to undergo rigorous evaluations of safety and efficacy. However, all of this changed in 1976 when Congress enacted the Medical Devices Amendments to the Federal Food, Drug, and Cosmetic Act. These amendments gave the FDA the authority to determine the safety and effectiveness of devices before they reach market. Under the amendments, the Center for Devices and Radiological Health (CDRH) took charge of the responsibility of this task. The scope of this job is enormous since approximately 4,000 new products receive market clearance each year.

Over the years, the FDA has streamlined its processes to reduce the review time needed for device approvals. Between 1995 and 2000, approval times for medical devices declined from 25 months to 12 months. The reauthorization of the Medical Device User Fee Program, which was part of the FDA Amendments Act of 2007 (signed into law on September 30, 2007), will also enhance the device review process.

“We’re pleased the legislation was passed by Congress and signed into law, which establishes a new user fee program allowing us to hire more experts to participate in premarket review of devices as well as handle adverse events, compliance, and everything else involved in keeping devices out there working safely and effectively,” says Heather Rosecrans, acting director of the program operations staff, office of device evaluation, CDRH.

In addition to maintaining predictability in user fees, the legislation streamlines the device inspection program by allowing accredited outside firms to conduct routine inspections for good manufacturing practices. It also helps the FDA focus its investigation efforts on high-risk products and production facilities.

“We’re constantly improving the program,” Rosecrans says. “We’ve hired more experts, many of whom have expertise in medical software, which is extremely important when evaluating these new medical device technologies.” In April, the FDA announced that it will hire 1,300 biologists, chemists, and medical officers over the next several months.

Device Classification System

In contrast to pharmaceuticals, medical devices are evaluated using a risk-based classification system that determines one of three regulatory pathways. Class I devices, representing low-risk items (such as surgical instruments and bandages), do not require performance standards, whereas Class II and Class III devices, representing medium- and high-risk equipment (such as infusion pumps and defibrillators), follow specific regulatory requirements. Both Class I and Class II devices must be manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged, and be properly labeled. Class II devices are more complex than Class I devices and often require certain controls to provide assurance of their safe and effective use. Class III devices constitute 3% to 5% of the products regulated by CDRH. The classification of the device identifies whether the marketing process will involve premarket notification 510(k) or premarket approval (PMA).

Manufacturers seeking to market a Class I, Class II, or Class III device intended for human use (for which a PMA is not required) must submit a 510(k) to the FDA. A 510(k) requires the demonstration of substantial equivalence to another legally US-marketed device, which suggests that the new device is as least as safe and effective as the predicate.

“It is not always perfectly clear what classification a device falls under, and there are some gray areas, which is why precedence plays a role,” Rosecrans says. “If another manufacturer has received clearance for a similar device in the past, this will be taken into consideration.”

The FDA requires a PMA for evaluating Class III medical devices. These are typically life-saving devices and therefore require the most stringent type of device marketing application. Nearly all PMA submissions require clinical data in addition to bench and possibly animal data in support of their application. When the Class III device is a first-of-its-kind or is significantly different from other known devices, an advisory panel of experts often reviews the data and offers a recommendation. Manufacturers who submit a PMA application also undergo inspections of their manufacturing facilities and processes.

The FDA has 180 days to review and render a decision on a PMA submission. As with 510(k) submissions, the approval can be delayed if the agency requires additional information. “It’s important that the manufacturer provides as much detail as possible in the first submission so unnecessary delays are avoided,” Rosecrans says. Manufacturers are also required to submit annual postmarket reports on the approved product, containing any new information related to the product.

Devices intended for use by patients with rare diseases are eligible for a humanitarian device exemption. Once the manufacturer obtains that designation, it must demonstrate that the disease or disorder for which the device is intended affects fewer than 4,000 people per year in the United States and that there are no other alternative treatments available for these patients.

Device Recalls

Once a device is in widespread use, unforeseen problems can sometimes lead to a recall. “The majority of device recalls are firm-initiated or voluntary recalls,” says Kimber Richter, MD, deputy director of medical affairs for the office of compliance, CDRH. “But sometimes these voluntary recalls occur after the FDA makes an inspection of a manufacturing site and discovers a defect that the firm really should have acted on through its own quality control processes.”

21 CFR (Code of Federal Regulations) 7 provides guidance to manufacturers to conduct effective voluntary recalls. In rare instances in which manufacturers or importers fail to voluntarily recall a device that is a risk to health, the FDA may issue a recall order to the manufacturer under 21 CFR 810, Medical Device Recall Authority.

The FDA classifies a medical device recall into one of three categories, depending on the relative degree of risk. These designations include:

Class I Recall: Reasonable probability exists that using a product will cause serious adverse health consequences or death. The manufacturer uses a press statement and a recall letter to notify customers of the recall, providing them with the name of the device being recalled; the lot or serial numbers; the reason; and how to correct, avoid, or minimize the problem.

Class II Recall: Using a device may cause temporary, slight, or medically reversible adverse health consequences. Customers are notified, but in general no press statements are issued.

Class III Recall: Using a product or being exposed to a product is not likely to cause adverse health consequences. Customers are notified, but in general no press statements are issued.

“In a Class I recall, the manufacturer has to report the status of the recall on a weekly basis to the district office closest to their site,” Richter says. For Class II or Class III recalls, this reporting usually occurs on a monthly basis. Close collaboration occurs between the manufacturer and the FDA to ensure that letters were distributed, responses were recorded, and devices were corrected. The FDA requires the company to disclose exactly how it intends to publicize the recall and how products should be returned for corrections.

“The FDA’s role is to oversee the recall and verify that the firm’s strategy reflects the right conclusions about the problem and how it should be corrected,” Richter says. “After the firm has made its corrections and the FDA has made all its final audits to the firm’s final report, the agency makes a decision as to whether the recall can be terminated.”

Notifying the Public

Class I recalls almost always warrant a press release to the media. Many other recalls are not announced in the media but instead are posted on the FDA’s weekly Enforcement Report (www.fda.gov/opacom/Enforce.html). “The manufacturer’s first responsibility is to notify the users of the product, and the primary way to do that is through a recall letter, which is often sent by express mail,” Richter says. “The company is required to conduct an effectiveness check related to this dissemination of information to prove to the FDA that they were received by the proper parties. The FDA will even send out field investigators to hospitals, homes, and wholesalers to verify that they received the letters and took the steps spelled out in the recall instructions.”

To ensure that the device continues to remain safe and effective following a Class I recall, the FDA sends investigators to the manufacturer to make sure the entire process is error free. With Class II or Class III recalls, the investigators generally follow up during the next regularly scheduled inspection appointment.

Equiment Documentation

Although the FDA has made great strides in ensuring that medical devices are safe and effective, a nagging concern among biomeds is that the FDA does not enforce the 21CFR regulation requiring manufacturers to provide a minimum of two complete and unabridged sets of operator manuals and one complete set of service manuals at no cost to hospitals. These manuals should be identical to the information supplied to manufacturers’ service representatives and should contain the diagnostic codes, commands, and passwords used in the maintenance, repair, and calibration of the equipment.

“Many manufacturers will say they don’t provide this type of information, while others say they will make it available for a fee of $8,000 or more per year, per machine,” says Patrick Lynch, CBET, CCE, MBA, biomedical support specialist, Global Medical Imaging, Charlotte, NC, and former director of biomedical engineering for Northside Hospital in Atlanta.

For more about FDA programs and recalls, search for “MedSun” and “FDA.”

Harrington concurs, saying, “Some vendors provide support, but there are many that won’t unless you commit to sending an employee to an expensive service class operated by the manufacturer.”

Several years ago, Lynch and a team of biomeds and other hospital employees visited the FDA to discuss the need for enforcement of this regulation. Lynch notes that nothing has changed since that meeting. This has become a politically charged issue because many large medical device manufacturers lobby and push for policies that will protect their service dollars from being eroded by hospitals and other third-party service organizations.

Another problem is that it is very difficult to establish that unsafe medical care is being provided because the service manuals are unavailable. Biomeds do not want to say they are providing unsafe care, and because biomeds working for hospitals and independent service organizations do not get named in litigation cases, there is no documented proof that there is a decrease in patient care or safety due to the lack of these resources.

On the other hand, the FDA states that with its limited resources, it is forced to focus on regulatory efforts involving the greatest risks. “The agency must determine the best way to utilize our investigators and regulatory personnel in the office of compliance, so it’s not possible to address every regulatory and enforcement issue,” Richter says. “But at the same time, we do monitor and assess complaints from hospitals related to manufacturers’ products and services.”


Carol Daus is a contributing writer for 24×7. For more information, contact .