Biomedical Engineers Role in Sustainability

1
Biomedical Engineers Role in Sustainability

• Dr. Gerald E. Miller
• Chairman, Biomedical Engineering
• Virginia Commonwealth University
• December 16, 2009

2
The Food Drug Administration

• Protecting the public
• Monitoring the development and marketing of
  foods, drugs and medical devices
• Maintains a log of recalls and issues
• Designed to assist in the sustainability of
  medical and food products

3
The role of universities

• IRB Protection of Human Subjects
• IACUC Protection of Animal Subjects
• Conflict of Interest Policies
• Intellectual Property Protection
• Peer Review for Research Publications
• Policy for RD ethics
• Policy for Industry sponsored research and
  development standards what is and is not
  appropriate?

4
The role of Biomedical Engineering Scientists
Researchers

• Follow appropriate peer review standards
  research publications
• Participate in the peer review process at the
  university and federal levels
• Maintain appropriate standards in dealing with
  biomedical industry
• Follow university and federal guidelines
  regarding integrity and conflict of interest

5
The FDA application process
6
FDA Application Process part 2
7
FDA monitoring of all products

• Application to Market a New Drug, Biologic or an
  Antibiotic Drug for Human Use form 356h
• Investigational New Drug Application - form 1571
• Transmittal of Annual Report for Drugs and
  Biologics for Human Use - form 2252
• Drug Product Listing for 2257
• Establishment Registration and Listing for Human
  Cells, Tissues, and Cellular and Tissue-Based
  Products (HCT/Ps) form 3356
• MedWatch The FDA Safety Information and Adverse
  Event Reporting Program form 3500
• Vaccine Adverse Event Reporting System

8
FDA food monitoring program areas

• Acidified and Low Acid Canned Foods
• Biotechnology
• Color Additives
• Cosmetics
• Dietary Supplements
• Food Ingredients and Packaging
• Foodborne Illness
• Bad Bug Book
• Microbiological Methods BAM
• Food Labeling and Nutrition
• HACCP Hazard Analysis and Critical Control Point
• Imports and Exports
• Infant Formula
• Inspections, Compliance, Enforcements and Recalls
  
• Medical Foods
• Pesticides and Chemical Contaminants
• Total Diet Study
• Seafood

9
FDA List of drugs medication guide

• http//www.fda.gov/cder/Offices/ODS/medication_gui
  des.htm
• DailyMed provides high quality information about
  marketed drugs. This information includes FDA
  approved labels (package inserts). This Web site
  provides health information providers and the
  public with a standard, comprehensive,
  up-to-date, look-up and download resource of
  medication content and labeling as found in
  medication package inserts.
• Other information about prescription drugs may
  also be available. NLM regularly processes data
  files uploaded from FDA's system and provides and
  maintains this Web site for the public to use in
  accessing the information. Additional information
  about medicines is available on NLM's MedlinePlus
  Web site http//www.nlm.nih.gov/medlineplus/medici
  nes.html.

10
FDA Medwatch

• MedWatch is the Food and Drug Administration's
  (FDA) program for reporting serious reactions,
  product quality problems, therapeutic
  inequivalence/failure, and product use errors
  with human medical products, such as drugs and
  medical devices.
• If you think you or someone in your family has
  experienced a serious reaction to a medical
  product, you are encouraged to take the reporting
  form to your doctor. Your health care provider
  can provide clinical information based on your
  medical record that can help us evaluate your
  report.
• The FDA Form 3500 should be used by healthcare
  professionals and consumers for voluntary
  reporting of adverse events noted spontaneously
  in the course of clinical care, not events that
  occur during clinical trials under an
  Investigational New Drug (IND) application. Those
  mandatory reports are to be submitted to FDA as
  specified in the investigational new
  drug/biologic regulations or investigational
  device exemptions. For instructions on mandatory
  reporting, go to http//www.fda.gov/medwatch/getfo
  rms.htm .

11
FDA Inquiries

• Drugs - Division of Drug Information,
  301-827-4570
• Nutritional Products Cosmetics - 1-888-723-3366
  
• Medical Devices - 1-800-638-2041
• Vaccines, Blood products, and other biologics -
  1-800-835-4709

12
Medical Devices FDA hot areas

• Lasik surgery
• Breast implants
• Medical Imaging systems proper exposure limits
• Contact lenses
• Heart assist technologies
• Dialysis systems

13
Food FDA hot areas

• Food safety chinese food additives
• Labeling
• Nutrition labels
• Dietary supplements
• Genetically engineered foods
• Packaging and sealing
• Usage dates

14
Drugs FDA hot areas

• Cholesterol lowering drugs
• HIV screening tools and drugs
• Cosmetics drugs or not?
• Blood pressure - hypertension, hypotension
  beta blockers vs diuretics
• Arthritis and joint lubrication and cartilage
  regenration
• Genetically engineered drugs
• Drug introduction injection of bolus,
  introduction of slow release capsules,
  introduction of specially designed genetic
  capsules

15
Radiation issues - FDA

• CT
• MRI
• Fluoroscopy
• Mammography
• X-ray
• Tanning beds
• Cell Phones

16
Combinational Products - examples

• Transdermal patch for treatment of Parkinsons
• Absorbable collagen sponge with genetically
  engineered human protein
• Biological gel for surgical hemostasis
• Transdermal patch for attention deficit disorder
• Transdermal patch for depression
• Inhaled insulin for diabetes
• Surgical mesh with antibiotic coating
• Spinal fusion putty
• Inhaled Flu vaccine

17
FDA beginning and end monitoring

• Premarket approval
• Clinical trials
• Post market analysis
• Adverse reaction list
• Consumer and physician reporting

18
What Biomedical Engineers can do?

• Proper research protocols
• Human use evaluation by special committee - IRB
• Animal use evaluation by special committee -
  IACUC
• Peer review for funding
• Peer review for publication
• Interaction with clinicians
• Interaction with patients

19
Biomedical Engineers safeguards regarding
sustainability

• IRB Institutional Review Board protection of
  human clinical trials and human based research
  conducted by an independent board
• IACUC Institutional Animal Care and Use
  Committee conducted by an independent board
• Patent Protection avoid frivolous patent
  applications

20
Sustainable medical devices, food and drugs

• Volunteering information vs Requiring information
• Physician information vs Patient information
• Company provided information vs independent
  information
• Public safety and efficacy is the primary issue

21
What to avoid the latest fiascos

• Additives to baby formula how could this have
  been prevented?
• Proper and continual monitoring?
• Timely response to problems once found?
• Timely recalls?

22
Long term answers - FDA

• FDA system has worked for over 150 years
  includes monitoring, approval process, and
  adverse reaction process
• More stringent monitoring of foreign foods and
  drugs
• More stringent monitoring and approval process
  for combination and tissue based drugs, devices
  and therapies
• Particular monitoring of drugs and foods for
  children, infants, and the elderly

23
Long Term Answers Biomedical Engineers

• Proper RD protocols
• Proper animal and clinical trials independent
  evaluation
• Involvement with clinicians and patients for
  continual feedback
• Careful use of industry sponsored research
• Care in the development of intellectual property
  as a major factor in biomedical research rationale

24
Sustainability Issues and Potential Solutions

• Develop sustainability protocols for FDA for
  foods, drugs, medical devices minimum 10 year
  use
• Develop drug protocols for companies that provide
  more extensive premarket testing
• Develop prescreening protocols for foreign drugs
  and foods