SAFETY SYRINGES

1
(No Transcript)
2
SAFETY SYRINGES SAVE LIVES AND SAVE COST
3
Company Introduction

• To reduce the risk of needle stick injuries, in
  1998 Hou-se Medical Inc.(former company of FMDI)
  became devoted in developing various patents for
  the advancement and production of - Safety
  Syringe.
• April 2002 based on Hou-se Medical Inc., Formosa
  Medical Device Inc. was established . FMDIs main
  goal is to expand development, manufacturing and
  marketing, most of all to put this safety
  product in use to protect the benefit of our
  paramedics.
• SafePro Safety Syringe will be FMDIs main
  product line to expand to the North America
  Market, establish the SafePro brand, to
  consolidate company resources and to continue to
  develop various safety products for diversified
  usage. FMDI aims to be one of the leading medical
  devices companies in the world.

4
Company History
5
Major Investors

• ? Wu Shun, Huang
• ? Mirle Automation Corp.(Listed on the TSE)
• ? Nak Sealing Technologies Corp.(Listed on the
  TSE)
• ? L K Engineering Corp (Listed on the TSE)
• ? Fu Sheng Group (Listed on the TSE)
• ? Taiwan Incubator SME Development Co.

6
US and Malaysia Patent

• US Patent No.
• 5,328,475 5,405,327 5,569,203
  5,562,627 5,575,774 5,591,131
  6,117,107 6,093,171 6,387,079
  6,432,088 6,514,229
• Malaysia Patent No.
• MY-110928-A, MY-113607-A

7
Needle Stick Percentage of Different Care Workers
8
Paramedics Needle Stick Injuries Estimation Chart
9
US Needlestick Injury Report

• Each year, up to 800,000 accidental needlesticks
  are report in the
• United States alone. It is estimated that only
  1/3 of accidental
• needlesticks are even reported

Resource Contamination incidents among doctors
and midvies reasons for non-reporting and
knowledge of risks. Occup Med
(Lond), 47(6), 357-60. 1997. Burke, S., Madan,
I.
The percentage of infection by Occupational
Exposure to Bloodborne Pathogens
10
US Needlestick Injury Report

• Average Direct Cost of Percutaneous injury and
  Mucocutaneous Exposures in the U.S.A.
• Tested as negativeUS205 Tested as
  positiveUS2,032
• Above does not include treatment, patient care,
  lost of working hours, mental damage and death
  costs

11
US Needle Stick Injury Report

• ? The California OSHA estimates that each
  needlestick injury costs about US2,2343,822,
  restrictions of Safety Syringes can save more
  than US1,000 million annually.
• ? Ohio OSHA imposes restrictions on using Safety
  Syringes to protect the states 40,000
  paramedics, this results in US1,200 million
  reduction of medical fees annually.

12
Product Features

• 1. Safety Function
• 2. Easy Use
• 3. Complete Specifications
• 4. High Quality
• 5. Stable Supply
• 6. Patented Technology

13
Certification of Product and Manufacturer

• ?FDAs approval of 510(k) submission
• 10/18/2001 K012726
• 8/29/2002 K022063
• ?Manufacturer - Mirle Automation Corp.
• - ISO9001 certified
• 7/18/2002 No.FM34233
• - GMP certified
• 10/17/2002 No.0910064574

14
Customer Preference Trail)TAMPA, FL. USA July,
2002 to Oct. 2002

• Coordinator M.S. (Nursing), ARNP Healthcare
  Professional, with
• over 15 years of increasingly
  responsible experience in
• community/private practice and
  clinical research
• settings.
• Participants Working in clinics, physicians
  offices and urgent care
• centers, and having
  experience ranged from 1 to 10
• years, injections given per
  week from 4 to gt20.
• Educational backgrounds included PA, RN, LPN and
  MA.
• Test Product 3cc 22Gx1 and 3cc 23Gx1 of SafePro
  Safety Syringe

15
Customer Preference TrailTAMPA, FL. USA July,
2002 to Oct. 2002
16
Product Specification
17
Product Specification
18
Product Specification
Available in June, 2003
19
Product Specification
delivery after 4 months receiving purchase order
20
Product Specification
5cc - available in June, 2003 10cc and 20cc -
delivery after 4 months receiving purchase order
21
Product Specification
22
Product Specification
23
Schematic for SafePro Safety Syringe
Breakable Point
Gasket
Shealth
Plunger
Collar
Syringe
Hub
Arrow Head
24
Step -1
Lock in the correct position. Insert the needle
into the barrel. You will hear a click when it
moves into the correct locked position.
Step 1 and Step 2 only applicable to non
pre-armed model
25
Step -2
Check the gap. Make sure there is no gap
otherwise, repeat step 1.
No Gap
Gap
26
Step -3
Check the needle. Pull the cap off
27
Step -4
Aspirate the medicine. Use standard medical
operating procedures for aspiration.
DO NOT push plunger to the end of the barrel.
Make sure hub is not pushing against the bottle
cap
28
Step -5
Inject the medicine.
At the end of the injection, push the plunger
into the end of the barrel.
29
Step -6
Push the plunger to a full stop to administer all
of the contents in the syringe and fully engage
the plunger with the needle. Withdraw needle from
patient.
30
Step -7
Retract the plunger by pulling the plunger at the
stopper point.
31
Step -8
Band off the plunger. Break off the "break-point"
of the plunger to keep the needle safely
contained within the barrel.
32
Step -9
Throw away. Dispose of the syringe in an approved
medical waste collector.
Sharps Container
33
THANK YOU