By Suzi Birz, principal, HiQ Analytics, LLC, contributor

Oct. 9 , 2009 - Today’s medical devices are extremely diverse - ranging from simple tongue depressors, glucose monitoring devices and personal protective equipment to programmable pacemakers with micro-chip technology, in vitro diagnostic scopes, and x-ray machines. But regardless of their complexity or function, hospital administrators, clinicians and their patients must trust in the manufacturers to produce safe, effective products.

But is that trust warranted?  How do we know these products are safe?

Two important processes impact the emergence of new medical devices on the market: approval and standards.  While both offer healthcare providers and the public a number of assurances about safety, they also leave some questions open to debate. Recent developments in these areas show the constant evolution of the medical device market and the forces that regulate it.

The Medical Device Market

The medical device market in the United States has exploded in recent years, reaching approximately $86 billion by the end of 2006, and it continues to expand. The industry is expected to grow an additional 10 percent over the coming year. (Source: AdvaMed 2006)

The United States Food and Drug Administration (FDA) has defined a medical device as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

• Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
• Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
• Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

The Approval Process – Well Defined, but Too Many Exceptions?

The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of medical devices, based on a well-defined process. Recent reports, however, have questioned whether the process allows too many products to incorrectly bypass the detailed review process using an exception, known as a 510(k) process, which applies to devices that are not substantially different from a device already being marketed.

Device Classifications and General Regulations. The FDA provides three classifications for medical devices, based on the degree of control necessary to assure that they are safe and effective. Class I devices are regulated by general controls, Class II devices are deemed to require special controls and Class III devices generally require premarket approval (PMA).  Class III devices include those that are life-supporting, life-sustaining or of substantial importance in preventing impairment of human health, or if the device presents an unreasonable risk of illness or injury.

All manufacturers of medical devices distributed in the U.S. must comply with these basic regulations:

• Annual establishment registration
• Medical device listing
• Premarket notification 510(k), unless exempt, or premarket approval (PMA)
• Investigational device exemption (IDE) for clinical studies
• Quality system (QS) regulation
• Labeling requirements
• Medical device reporting (MDR)
  

According to the FDA, most Class I devices are exempt from premarket notification 510(k); most Class II devices require premarket notification 510(k); and most Class III devices require premarket approval. A PMA is a scientific, regulatory documentation to FDA to demonstrate the safety and effectiveness of the Class III device, including clinical and non-clinical information. This premarket approval is required for Class III devices being introduced for the first time or reintroduced with significant changes or modifications. 

“Manufacturers can avoid this step by showing that their new device has the same intended use as the predicate device and the same technological characteristics or device is demonstrably as safe and effective as an already marketed device,” explained Sharona Hoffman, co-director of the Law-Medicine Center and professor of law, Case Western Reserve University School of Law, Cleveland, Ohio.

FDA provides guidance documents and databases to assist manufacturers in compliance. One database is the FDA Recognized Consensus Standards, those standards recognized by FDA to which manufacturers can declare conformity. Information submitted on conformance with such standards will have a direct bearing on safety and effectiveness determinations.

FDA’s Safety Net for Healthcare Providers

In addition to helping manufacturers, the FDA provides a number of resources for consumers and healthcare providers. 

The FDA Medical Devices site for healthcare providers includes:

• General information on safety, including device recalls, alerts and other information
• Medical Product Safety Network (MedSun) - a collaborative partnership between FDA and the clinical community to identify adverse events for medical devices
• FDA Patient Safety News – a televised video series for health care professionals on medical devices, drugs and other FDA-related issues
• Public health notifications regarding risks or problems with specific devices
• Mammography information about facility certification and quality standards
• Information on quality standards for laboratory testing to ensure the accuracy, reliability and timeliness of patient test results
  

Recent Developments

New Portal Links Standards from AAMI, ANSI, ASTM & DIN. The FDA Recognized Consensus Standards database helps people determine what standards apply to a device. Standards related to medical devices are created by several national and international standards organizations.

Recognizing the complexity of standards that apply to medical devices and the imperative that decisions be made quickly, the Association for the Advancement of Medical Instrumentation (AAMI), the American National Standards Institute (ANSI), ASTM International, and DIN (the German Institute for Standardization) have launched the Medical Device Standards Portal to help manufacturers “make the right decision.”

The Medical Device Standards Portal allows users to:

• Access a link directory between 318+ ASTM standards, more than 1,000 referenced full-text standards from International Organization for Standardization (ISO), International Electrotechnical Commission (IEC), AAMI, DIN, and FDA, and various European regulations.
• Compare revisions to any document with color-coded highlights denoting changes.
• Make notations directly in the standards and share your analysis online with others.
• Integrate company practices and policies into the standards, preserving and passing on expertise.
• Search by keywords and see these keywords highlighted within each standard that includes the keyword(s) or phrase.
  

IOM to Study Premarket Notification Program. The FDA recently announced that it has commissioned the Institute of Medicine (IOM) to study the premarket notification program used to review and clear certain medical devices marketed in the United States.

The IOM study will examine the premarket notification program, the 510(k) process.   While the IOM study is underway, the FDA’s Center for Devices and Radiological Health will convene its own internal working group to evaluate and improve the consistency of FDA decision making in the 510(k) process.

“The 510(k) process has become so popular with manufacturers who wish to avoid the more onerous and lengthy PMA procedure that over 75 percent of medical devices are approved through this process,” stated Hoffman.

Read more: 
FDA Site for Medical Devices
Medical Device Standards Portal

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