|Interview with the Chairman of the 2001 ASTM Board of Directors:
Donald E. Marlowe
On a wall in his office at the Food and Drug Administration laboratories
in Rockville, Md., Donald Marlowe has a bulletin board covered
with slide rules. Hes been collecting them in various shapes
and sizes for some years, and enjoys the reminder of his origins
as a scientist trained in the days when NASA went to the moon
on the slide rule.
A scientist and administrator since his career began with the
National Bureau of Standards in 1963, Marlowe has successfully
navigated the changing tides in technology, regulatory agendas,
and standardization, and brings his knowledge to bear in this,
his year as ASTMs chairman of the Board.
In this interview with SN, Marlowe talks about the regulatory
and standards-developing mandate of his FDA branch, the Center
for Devices and Radiological Health, as well as upcoming challenges
for ASTMs technical committees and the Societys future.
You work for the U.S. Food and Drug
Administrations Center for Devices and Radiological Health. What
important areas of public health and safety does the CDRH regulate?
FDA regulates about one dollar in five of the Gross National Productfoods,
drugs, medical devices and veterinary drugs. Medical devices,
which the CDRH regulates, are a comparatively small part of the
total. However, virtually everyone in the population can relate
to a medical device of some type. Many of us wear eyeglasses or
use a hearing aid. Many also know someone who has an implant such
as a total hip or intraocular lens. In addition, virtually all
of us own televisions and microwave ovens. Many of us have had
dental x-rays, mammograms or other forms of diagnostic x-rays.
The safety of all of these types of products is regulated by FDA/CDRH.
So, in general, the Center for Devices and Radiological Health
thinks of our responsibilities as promoting and protecting the
public health by ensuring the safety and efficacy of medical devices
and the safety of radiation emitting electronic products.
The National Technology Transfer and Advancement Act of 1995 requires
that all federal agencies utilize private-sector voluntary consensus
standards. How has FDA responded to the NTTAA since its implementation
in the mid-1990s?
One of the things were quite proud of at CDRH is that our whole
program relating to standards, dating back to the late 1970s,
has been based on the premise of using consensus standards to
describe how devices should perform. The Medical Devices Amendments
of 1976 required that more than half of medical devices meet performance standards. To
manage the risks from this majority of devices, the original concept
was for government to write regulatory standards for these products.
It was quite apparent to us that it was an impossible task for
the government to write regulatory standards for about 1500 types
of medical devices. So we adopted a consensus standards pattern
very early on, and started weighing heavily into medical device
standards work in both national and international venues.
Just within ASTM, the FDA is heavily involved in Committees F29
on Anesthetic and Respiratory Devices, consumer product Subcommittees
of D11 on Rubber, F04 on Medical and Surgical Materials and Devices,
and more. And we are also active in other standards developing
organizations, primarily the Association for the Advancement of
Medical Instrumentation and NCCLS, which develops standards for
the clinical healthcare community. The Tech Transfer Act enabled
us to strengthen the message we were trying to convey to the medical
device manufacturers about the inherent benefits of developing
performance standards through the consensus process.
Under your direction, the Office of Science and Technology within
the CDRH conducts research in support of FDA regulatory decisions.
What kind of research is conducted there and how does this research
translate into standards development?
The Office of Science and Technology (OST) is the laboratory of
CDRH. OST supports the scientific basis for the agencys regulatory policies through
development of independent laboratory information for regulatory
and other public health activities of the CDRH. OST accomplishes
this mission by managing, developing, and supporting standards
used for regulatory assessments; performing laboratory evaluations
and analyses in support of CDRH pre-market and post-market activities;
developing data needed for current and future regulatory problems;
and performing research and anticipating the impact of technology
on the safety, effectiveness, and use of regulated products.
Specifically, OST develops and conducts research and testing programs
in the physical, life, and engineering sciences related to the
human health effects of radiation and medical device technologies.
It provides expertise and analyses for health-risk assessments.
The Office also develops new or improved measurement methods,
techniques, instruments, and analytical procedures for evaluating
product performance and reliability. OST provides innovative solutions
to public health problems through the development of generic techniques
to enhance product safety and effectiveness.
How do standards support the regulatory mission of FDA?
The appreciation on our part that we might best manage the risks
of products through the development of consensus standards is
key to our ability to manage the expenditure of resources it takes
to get the products through the approval process to market. Standards
are used to support every regulatory requirement of the Center.
All manufacturers may declare conformance with a recognized
consensus standard in lieu of submitting data to fulfill a regulatory
requirement. Since our first list of recognized consensus standards
was published in February of 1998, FDA has recognized more than
650 consensus standards. Another direct application of standards
by FDA is in the area of quality systems. The Quality Systems
Regulation is largely based on consensus standards.
You are active in the Association for the Advancement of Medical
Instrumentation. AAMI has recently committed itself to the development
and use of ISO standards only. Can you comment on how decisions
such as AAMIs impact SDOs such as ASTM?
For our program, the work of the two organizations is very complementary.
Each has developed areas of expertise and competence that are
independent of the other. We could not accomplish our program
without the contributions of both. Its a very symbiotic relationship,
and it works very well.
In a larger sense, wherever the industry looks for answers in
the standards world, thats who well work with. Ten years ago,
I was one of the strongest proponents for using U.S.-developed
technology as the basis for international standards. I thought
that the best way of getting the best technology into the standards
was to use that approach, simply because the United States tends
to have more resources available to solve a problem, and historically
has been more willing to contribute those resources to develop
the standards than anyone else in the world.
Today, Im not so sure. In fact, I think I would say I have changed
my emphasis on the international standards. I think that they
have not demonstrated the necessary value-added to make them the
only source. So a best-technology approach is how we want to go.
From the FDAs perspective we want to recognize the best standards,
and if you look at the standards that the agency has recognized,
I think thats the approach youll see playing out.
When and how did you first become involved in ASTM?
I first attended ASTM Committee Week meetings in 1965. At the
time, I was working at the National Bureau of Standards, now the
National Institute of Standards and Technology, in the areas of
force measurement and measurement of the physical properties of
materials. I joined ASTM in 1968 as a member of then-Committee
E09 on Fatigue when I became interested in the fatigue behavior
of aircraft materials and parts. Today, I still have friends on
the committees I joined back in the 1960s.
Your primary ASTM committee affiliation is with Committee F04
on Medical and Surgical Materials and Devices. What are some of
the significant challenges Committee F04 has confronted in standards
I suspect the challenges that face F04 are not much different
from those that face other product committees of ASTM. The combined
impacts of the globalization of the marketplace and the economics
of mergers have yet to be fully measured.
Another challenge for these committees is to build, or rebuild,
an academic base in the committee membership. Im not proposing
a shift in the balance of the membership of a committee but I
am suggesting that, without a viable academic presence, the technology
used by the committee tends to go stale. Participation by academics
and, in the case of the committees developing standards for medical
devices, clinical experts is very hard to come by. No one pays
their way to meetings or other expenses. It is very hard for them
to justify days away from their institutions to work on standards.
Committee F04 has helped ensure public health and safety through
its standards development. What are some accomplishments of F04
in this regard in which you or members of your staff have taken
FDA has been a significant player in F04 since it was formed,
and it would be hard to single out individual accomplishments
that FDA initiated. However, the current standards development
effort in tissue engineering is one area spearheaded by FDA players.
The people at FDA who participate in ASTM have all been very active
in committee work and hold a lot of leadership positions on ASTM
committees. In the development of medical device standards, very
often, FDA has the only public-sector data to bring to the discussion.
Manufacturers generate information and data that comes to the
standards table, but often FDA is the only public sector participant
with the resources to develop new data. Consumers dont have the
resources to develop this kind of work. FDA is committed to the
development of standards through the consensus process and thats
been the case for 25 years with no change.
In your more than 30 years of participation in the Society, how
have you seen ASTM change? How do you feel the Society is situated
for the business and standards development challenges of the future?
ASTM has adopted the concept of the information economy. Fortunately,
we did it early in the development of the technology. Ive watched
and participated as ASTM worked through several generations of
equipment and software to support the new technology requirements.
While it was painful and expensive, let me assure you that ASTM
is now the envy of many of our colleagues in the standards world.
I was complimented just recently week on our ability to publish
and distribute information in ways that are unrivaled. Several
societies have been or are thinking about approaching ASTM to
do their distribution of information.
What are the challenges you see for ASTM in the coming years?
Well, I addressed some of this earlier in the interview with regard
to maintaining academic and clinical participation. In addition,
I have not been able to assess the impact of electronic publication on the overall
funding stream of the Society. The growing trend in technical
information is to make such information free to the user. This
could threaten standards developing organizations that depend
on the publication of information for income. The secret will
be the ability of the Society to sustain the quality of the information
and the value it provides to the user.
Regarding ASTMs place in the international arena, Im a strong
believer in market-driven international standards. ASTM has a
high- quality product technologically. This fact is recognized
in those industries and communities that come to ASTM to develop
their standards, the building community and the petroleum industry,
the environmental community, and so many others. So I think that
our standing internationally is based on our ability to produce
the best standards in a timely way. And as long as we continue
to do that, we will fare well internationally.
Is there anything else you want to add?
I hope that 2001, the first year of the new millennium, is a good
year for all our members and the committees they serve on. If
there is any way that the Society staff or leadership can be of
assistance in accomplishing your goals, were here to help.
Copyright 2001, ASTM