Page 27 - Safety Risk Management for Medical Devices

6 Safety Risk Management for Medical Devices

FLIP-DOWN
SAFETY ROPE-WHEN SUN GLASSES ROLL BAR HARD HAT WITH WIDE BRIM
OTHER SYSTEMS FAIL & EAR PROTECTORS
PADDED-BACK SEAT
AUTOMATIC
HIGH-VOLUME “WHOA” & HEAD RESTRAINT
BACK-UP LIGHTS
BIRD-CAGE MASK & TAIL LIGHTS & DIRECTIONAL LIGHTS
SAFETY GOGGLES SHOULDER HARNESS
180° REAR VIEW MIRROR AUTOMATIC, AIR-FILLED
CHEST PROTECTOR
HEAD LIGHTS
MAPS, IF YOU GET LOST
PRESCRIPTION SAFETY & CHECK LIST BEFORE RIDING
GOGGLES TO INSURE BLUE-TAIL FLY REPELLENT
HORSES GOOD VISION.
SEAT BELT
GRAB-RAIL
SELF STARTER (ACCESSORY)
SAFETY SWITCHES & “HOT LINE”
TO INSURANCE COMPANY KNEE PADS (JUST IN CASE)
& QUILTED PANTS
STEEL-TOED STIRRUPS
SAFETY NET E.P.A.
ALL AROUND
EMISSIONS
CONTROL
4 WHEELS SYSTEM
TO KEEP HORSE
UPRIGHT IN CASE
HE SLIPS –
HENCE NOT
ENDANGERING DUAL
THE RIDER. CINCH NON-SKID SPARK SUPPRESSORS
Cowboy after O.S.H.A.
Figure 2.1 Overengineered cowboy.
The cartoon in Fig. 2.1 was drawn by J.N. Devin in 1972. Although it gives a
comical view of overengineering, there are some lessons hidden in there. It shows
when a good intention can go awry to the point of making a product useless.
2.2.2 Avoiding recalls and field corrective actions
Safety violations are the main reason for product recalls, and Field Corrective Actions.
Product recalls are very expensive, and expose manufacturers to lawsuits and poten-
tially large fines, settlement costs, and legal fees. Moreover, the reputation of a manu-
facturer may become tarnished and future sales hampered.
Good risk management practices can reduce the probability of harming people or
the environment, and thus avoiding recalls.
One of the most important benefits of risk management is that it provides leading
indicators for potential future problems. In many cases a manufacturer realizes only after an
adverse event, that they are in trouble and facing a lawsuit, or punishment by Regulatory
bodies. Risk management enables manufacturers to identify the highest risks associated
with their products and be able to forecast the probability of serious adverse events.

2.2.3 Better communications
An unexpected side benefit of risk management is improved communication. In
most companies the product-development teams become siloed, which means poor