By Alan P. Schwartz
Change for the sake of change is not always a good thing. But when change can be beneficial to all parties involved, getting mutual agreement on change may be easier and actual implementation faster.
Such could be the case with proposed new good manufacturing practices (GMP) for the medical product manufacturing industry. They come along in a sequence of regulations that have polarized an important manufacturing sector and their impact, good or bad, depends on how this change is implemented.
FDA’s Record on Identifying Defective Product Designs
On March 13, 1984, the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. Congress House of Representatives, held hearings on medical device failures, specifically deaths resulting from cardiac pacemaker leads that malfunctioned due to design problems. It was determined the Food and Drug Administration (FDA) was unable to anticipate or address these kinds of problems under the 1976 amendments.
An FDA study title “Device Recalls: A Study of Quality Problems,” published in May, 1990, contained reports that approximately 44 percent of the quality problems that led to voluntary recall actions during the six years from October 1983 to September 1989 were attributable to errors or deficiencies that might have been prevented by mandated design controls. Devices with design-related defects included both noncritical and critical devices. There was no indication if the recalled devices were involved in any deaths or injuries.
In 1990, The Department of Health and Human Services inspector general conducted a study titled “FDA Medical Device Regulation From Premarket Review to Recall.” The devices selected for this study were all critical devices: defibrillator/cardiac monitors, balloon catheters, spinal fixation systems, heart valves, lithotripters, balloon inflation devices, insulin infusion pumps and ventilators.
Congress Responds with Legislation
The Safe Medical Device Act (SMDA) of 1990 gave the FDA the power to implement the Preproduction Quality Assurance program that required medical device manufacturers to address flaws in product design which contribute to malfunctions. If further required devices submitted for 510(k) review be documented as safe and effective for their intended use-that is, to meet a known performance standard.
Since April, 1992, the Office of Device Evaluation (ODE) has required device manufacturers to demonstrate safety and efficacy with various tests including biocompatibility, electrical safety, electromagnetic interference and, in may cases, clinical testing. This testing is now deemed necessary to obtain a finding of substantial equivalency for a 510(k) device.
Costs and Results
The results of a 1992 survey of manufacturers indicated costs incurred by these additional testing requirements ranged from $10,000 to $50,000 per product under 510(k) review. Just using the lower end of the scale represents an industry-wide expenditure of approximately $120 million to complete 510(k) reviews since SMDA was enacted.
Maybe the FDA should determine if devices on the market since 1992, having met these additional and costly requirements, have experienced fewer recalls, deaths and malfunctions. They should gather this pertinent data before implementing new regulations that will cost the industry an additional $84 million.
That’s what it could cost to incorporate the necessary testing and documentation into product development in order to comply with new requirements for proper design controls, requirements calculated to reduce malfunctions and defects. These costs do not take into account the time spent dealing with inspections by inexperienced agency investigators who impose on the industry their own biased interpretations of regulations meant to insure safety and efficacy.
Challenge to Create and Pass Meaningful Legislation
If Congress and the FDA really want to make sense of imposing these additional regulations on an industry already reeling from increased 510(k) review times and stricter FDA enforcement policies, they should reevaluate the 510(k) review process, as it is practiced, in light of these new requirements.
It appears the ODE presently requires all products submitted for 50(k) review go through a preproduction quality assurance check – in addition to other testing – before being cleared to market. The proposed GMPs would make this process a legal requirement.
If the FDA is going to inspect companies to assure they have such a program in place, any company in compliance – and therefore with sound product design controls – should not have to wait out the inordinate length of the current comprehensive 510(k) review process. Instead, a company in compliance should be able to market its product within 90 days of submitting a 510(k) notification.
A formalized design-review process, applied in this fashion, offers benefits to all parties and the 510(k) backlog would disappear as would the need for user fees.
After all, FDA justifies the design-review requirements as necessary to assure all devices are designed to meet specifications and tested before release to the market – the same thing additional ODE reviews now require. Eliminating this redundancy reduces both agency and industry workload and related costs.
Everyone Can Benefit
There are real values to be gained from the revised GMPs and changes to the 510(k) review process – to the agency, the industry and the public. New devices and technologies would be marketed more rapidly, encouraging new companies to form and the investment community to open the flow of dollars. The public would enjoy economical quality health care and have access to products designed to minimize defects.
Let’s stop hitting this industry with regulations that hinder technological advancement and an ability to compete. Let’s concentrate instead on how to use laws effectively to assure safer devices and assist industry growth and prominence in the world marketplace.
But looking at both areas of regulatory requirements, the review process and proposed GMPs, the government has the chance to create meaningful legislation. Both Congress and the FDA can demonstrate they are implementing laws that benefit and protect the health-care consumer and the industry they regulate by eliminating redundancy instead of making laws for the sake of making more laws.
Above all, let’s not allow this chance for real value to pass us by.
Alan P. Schwartz is founder and Executive Vice President of Medical Device Inspection Company, Inc., and international consulting company specializing in FDA regulatory affairs and quality assurance. Formerly with the FDA, Schwartz is part of the Medical Manufacturers’ Information Council advisory group and has spoken at several industry events, including RAPS, MDM, IMDEX and FMDA. Contact him at MDI Co., Inc., 55 Northern Blvd., Great Neck, NY 11021, Tel (800) 44804407, Fax (516) 482-0186
This article was published in the Medical Industry Executive, February/March 1994 and is reprinted with the permission of the publisher