Medical equipment: Is new always better?
V. R. Pertelle
The rapidly changing nature of medical devices submitted for FDA approval for homecare will require more advanced testing technologies during the product development cycle and validation in order to assure quality, safety and effectiveness for our patients. It will also require the creation of data that can be used to quantify the unique value of the products that results in a HCPCS code with appropriate reimbursement and most importantly reduce the incidence of product recalls.
By FDA definition, a medical device is any product or equipment used to diagnose a disease or other conditions, or to cure, to treat or to prevent disease. The FDA’s Center for Devices and Radiological Health (CDRH) regulates medical devices to provide reasonable assurance of their safety and effectiveness. A home healthcare medical device is any product or equipment used in the home environment by persons who are ill or have disabilities. Examples of some home healthcare devices are ventilators and nebulizers, wheelchairs, infusion pumps, blood glucose meters, apnea monitors, and other home monitoring devices.
The FDA’s regulatory approaches to marketing approval of the products it regulates are as varied as the products themselves. Laws the FDA enforces dictate the differences and some products - such as new drugs and complex medical devices - must be proven safe and effective before companies can put them on the market. At the heart of all the FDA’s medical product evaluation decisions is a judgment about whether a new product’s benefits to users will outweigh its risks. No regulated product is totally risk-free, so these judgments are important.
Unlike pre-market approval (PMA), which requires demonstration of reasonable safety and effectiveness, most home healthcare medical devices are submitted for 510(k) approval that requires demonstration of substantial equivalence (SE). SE means that the new device is as safe and effective as the predicate device(s). A device is SE if, in comparison to a predicate device it: has the same intended use as the predicate device; has the same technological characteristics as the predicate device; or has different technological characteristics that do not raise new questions of safety and effectiveness, and the manufacturer demonstrates that the device is as safe and effective as the legally marketed device.
A claim of substantial equivalence does not mean the new and predicate devices must be identical. According to the FDA, SE is established with respect to intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, standards, and other applicable characteristics. Once the device is determined to be SE, it can then be marketed in the United States. The drawback is of course with regards to the unique geometries of many of today’s medical devices used in home care, clinical algorithms (as well as patents) that create differences of one device versus a predicate device. The end result occasionally is a device recall.
A recall is a correction or removal of a product thar is defective, could be a risk to health, or is in violation of FDA regulations. Recalls may be conducted on a manufacturer’s own initiative or by FDA request. If the company does not comply with FDA’s recall request, the FDA can seek a court order to seize the product, require the manufacturer to cease distribution and/or require the manufacturer to notify all persons who use the product. The manufacturer or distributor of the product carries out most recalls voluntarily. However, the FDA can request a recall if the product is defective, could be a risk to health, or is in violation of FDA regulations, and the manufacturer does not recall the product on their own. Three categories, Class II, III, and I represent recalls. Class I, represent the highest level of risk and is reserved for products that could likely cause serious health problems or death. The healthcare continuum has experienced a number of device recalls this year that could potentially have been avoided by a more aggressive product evaluation process in the lab, on the bench or in clinical trials.
Typical methods of evaluation for home healthcare medical devices have been by way of bench simulators. The simulator, however, may not subject the device to the same loading that might occur in a clinical setting. That could be due to size differences in human vascular systems, differences in physiological responses or other factors.
This means that there is a need to evaluate devices in a clinical setting - at a close point following approval by FDA for substantial equivalence. This approach, however, may be considered by some as another cumbersome step, time consuming and costly. Yet it is paramount in assuring patient safety, quality and effectiveness and more importantly generate data that is essential for our industry in defending new and “unique” HCPCS with appropriate reimbursement and define the service necessary by providers for therapeutic use of the device on patients. In order for the process to be effective, close collaboration amongst stakeholders (manufacturers, homecare providers, physicians, consumers) must occur. The FDA has implemented a similar process of collaboration within their organization to promote and protect the public health. The process is called the Total Product Life Cycle Model (TPLC). TPLC goals are to be applied across center activities and include a focus to education and partnership with staff and stakeholders. It uses scorecards to align center work with the TPLC, and it uses multiple pilots to accelerate implementation, realign center incentives to support TPLC and harmonize CDRH and international regulation. It is incumbent upon us as an industry to collaborate more consistently and to work more efficiently with policy makers and educate them on our essential value in the continuum of care. Product development and evaluation is an excellent opportunity to support collaboration that creates “wins” across the board.
The FDA has streamlined its review process for medical products in recent years to help bring important new treatments to patients. For example, the average review time for an innovative new drug is now only six months, and some have been approved even faster. In August 2003, the commissioner of the FDA announced a new goal for reducing the amount of time that premarket approval applications for medical devices remain under review by the agency. The goal is to reduce by 30 days the “FDA time to 50% approval” for both expedited and regular PMAs.
New products are continually in development and the need for new technology in healthcare is greater. In the whole scheme of the healthcare continuum, there is a question that must be asked: Is new better? The answer may be different depending on whom you’re talking to, and “better” is of course relative depending on where the interests are. However, if we begin to collaborate as an industry to develop quality products that meet the needs of our patients without forcing cost shifting, then we position ourselves to produce cost efficient medical devices that we can defend to get new HCPCS with appropriate reimbursement while assuring patient safety, quality of care and reduced the incidents of recalls. When this occurs on a continual basis then the answer will always be - new is better.
Vernon Pertelle is Apria Healthcare’s national respiratory manager.