Survey of
nearly 1,000 hospital professionals backs need for UDI
Safety
Institute Device Recall Survey
On October 20, 2006, a
“device recall survey” was sent via e-mail to the subscribers of
Premier Inc.’s Safety Institute Safety Share newsletter.
The survey was part of Premier’s effort to gather information on
the current methods used in healthcare settings to record and
track information on medical devices.
It was noted in the
request for participation that the information gathered in the
survey would be shared with the FDA as additional insight into
how a unique device identification (UDI) system may improve
patient safety by facilitating device recalls and improving
medical device adverse event reporting. Premier submitted the
survey results with its formal comments to the FDA on November
9, 2006.
Survey findings
- More than 80
percent of respondents stated that a national UDI system
would enhance patient safety.
- The most common
method used to record information on a patient record
regarding an implanted medical device is transfer of a
product label into the patient’s record (60 percent).
- When recalls
occur, nearly all hospitals are conducting manual searches
of records or logs to identify patients who received a
recalled device or product.
Respondent
characteristics
A total of 948
individuals responded to the survey. Respondents were asked to
select a job type that best represented their responsibilities.
These are the job types reported by respondents:
Table 1
|
Job type |
Number of
respondents |
|
Administration |
175 |
|
Infection
control |
172 |
|
Materials
management |
149 |
|
Risk
management |
120 |
|
Nursing |
111 |
|
Quality
services |
111 |
|
Surgery/OR |
93 |
|
Clinical
support |
81 |
|
Safety |
74 |
|
Pharmacy |
32 |
|
Facility/environment |
27 |
|
Regulatory
compliance |
27 |
|
Physician/medical
|
25 |
|
TOTAL |
948 |
Table 2
|
1. To the best of your
knowledge, which methods or system (s) do you currently
use to record information in the patient record on the
medical devices that are implanted in a patient? Check
all that apply: |
|
·
Hand written recording of
the device in patient record |
51.1% |
|
·
Transfer of text label
provided by the medical device company into the patient
record |
60.1% |
|
·
Transfer of a bar coded
label (or other device identifier) from the device into
the patient record. |
40.8% |
|
·
Don’t know |
19.6% |
|
·
Other
|
8.7% |
|
|
|
|
2. Do you have a system or
database, beyond the individual patient record, to track
or record medical devices that are implanted in a
patient? |
|
·
Yes |
46.2% |
|
·
No |
20.8% |
|
·
Don’t know or not applicable |
33% |
|
|
|
|
3. Which of the following
systems do you use to label patient care equipment or
medical devices (e.g., IV pumps) for the purpose of
locating or tracking them. Check all that apply: |
|
·
Manual method (e.g.,
handwritten or text label) |
65.8% |
|
·
Electronic method (e.g.,,
bar coding) |
28% |
|
·
Radiofrequency
identification (RFID) |
2.8% |
|
·
Don’t know or not applicable |
15.4% |
|
·
Other |
6.1% |
|
4. When there is a recall of a
medical device, either implanted or patient care-related
device, what method do you currently use to track or
locate the device and/or the patient? Check all that
apply: |
|
·
Manual review of patient
record |
42% |
|
·
Manual review of logs |
58.4% |
|
·
Electronic retrieval of
information |
40.5% |
|
·
Don’t know or not applicable |
16.2% |
|
·
Other |
5.6% |
|
|
|
|
5. To what degree do you
believe that having a unique device identifier system
would enhance patient safety by improving your current
process for recording device information and tracking
recalls? |
|
·
None |
2.3% |
|
·
Minimal |
6.8% |
|
·
Somewhat |
27.7% |
|
·
Greatly |
52.7% |
|
·
Don’t know or not applicable |
10.5% |
|
|
|
|
6. Are you currently
establishing your own identifier for products once they
are received and before they are distributed to
patients? |
|
·
Yes |
28.7% |
|
·
No |
32.2% |
|
·
Don’t know or not applicable |
39.1% |
