Toothworks Safety Engineered Needle Information Tracking Form

A. Background

Date Investigation Completed

YearMonthDay

Name of Medical Sharp:

Purpose / Use of medical sharp:

A safety-engineered version was not found to be commercially available:

Go to Section B

A safety-engineered version was found to be available but was determined to be unsuitable at this time:

Go to Section C

B. Commercial Availability

The following sources of information were reviewed or investigated, but a safety-engineered version of the device was not identified:

InternetPeersProducts / Supplier BrochureLiterature Search

The following suppliers were contacted:

YearMonthDay

C. Suitability of Safety-engineered Needles

A safety-engineered version was identified but was considered unsuitable at this time due to the reasons that were identified during investigation:

The device is not yet licensed by Health Canada as a Medical Device in Canada

Option 1Option 2Option 3

Impact on Patient Care

Needle penetration not comparable (unfavorable) to conventional deviceRequires increased number of needle penetrations during usePatients report a higher degree of pain or discomfort.Device is not compatible with other equipment currently usedAn infection control concern has been documented

Technique

Requires change in technique that has yet to be adopted

Safety Features

Activates prematurely during difficult proceduresCauses pain or discomfort to staff using the device

Other concerns raised and considered valid:

D. Follow Up

Action Items for Follow-Up:

Bring Forward Date for re-evaluation:

MonthDayYear

Approved by HSR

Form Updated 2015-04-22

Safety-Engineered Needle Information Tracking Form