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Policies,Administrative,UWHC,Department Specific,Surgical Services,Administrative

Medical Devices FDA Tracking in Perioperative Areas (1.37)

Medical Devices FDA Tracking in Perioperative Areas (1.37) - Policies, Administrative, UWHC, Department Specific, Surgical Services, Administrative

1.37

UNIVERSITY OF WISCONSIN

POLICY & PROCEDURE

EFFECTIVE DATE

March 1994
ORIGINAL
 REVISION

OCTOBER 2017
PAGE 1
OF 4
POLICY #

1.37
ADMINISTRATIVE MANUAL
NURSING MANUAL
OTHER SURGICAL SERVICES
TITLE
MEDICAL DEVICES FDA TRACKING IN
PERIOPERATIVE AREAS


I. PURPOSE
A. This policy will enable UW Health to comply with the FDA Safe Medical Devices Act
which will track the purchase, implant, explant and disposition of certain medical devices.
The policy applies to inventory tracking of FDA tracked items only.


II. POLICY
A. The devices that must be tracked are as follows:
1. Below is the expert from the Medical Devices Tracking- Guidance for Industry and Food
and Drug Administration list, as of March 27, 2014


UNIVERSITY OF WISCONSIN

POLICY & PROCEDURE

EFFECTIVE DATE

March 1994
ORIGINAL
 REVISION

OCTOBER 2017
PAGE 2
OF 4
POLICY #

1.37
ADMINISTRATIVE MANUAL
NURSING MANUAL
OTHER SURGICAL SERVICES
TITLE
MEDICAL DEVICES FDA TRACKING IN
PERIOPERATIVE AREAS



2. Other devices as required by the FDA, but not referenced above.
a) Ventricular Assist Devices
b) Others as identified by the manufacturer




UNIVERSITY OF WISCONSIN

POLICY & PROCEDURE

EFFECTIVE DATE

March 1994
ORIGINAL
 REVISION

OCTOBER 2017
PAGE 3
OF 4
POLICY #

1.37
ADMINISTRATIVE MANUAL
NURSING MANUAL
OTHER SURGICAL SERVICES
TITLE
MEDICAL DEVICES FDA TRACKING IN
PERIOPERATIVE AREAS


III. PROCEDURE

A. Surgical Services leaders or their designee (e.g., AFCH Service Champions, Care Team
Leaders) will inform Intraoperative and/or Inventory Control personnel which items are
required to be tracked and assure the following steps are completed.

B. Tracking information is to be gathered at three phases in the process (e.g., upon receipt,
when implanted/explanted or when removed from inventory).

1. Upon Receipt:

a) Devices received by UW Health:
(1) If accepted by Receiving, documentation is performed by the
Inventory Control Specialist for the service line where the item is stocked
via the FDA Tracking Log. Record the following information:
(a) Name of device
(b) Lot number, Batch number, Model number or Serial
number or Unique Device Identifier (UDI). Include all of these
that apply.
(c) Date device received
(d) Manufacturer or representative/courier
(2) If a device is accepted via a representative or courier,
documentation is performed by either the Inventory Control Specialist or
the Materials Coordinator. Record the following information:
(a) Name of device
(b) Lot number, Batch number, Model number or Serial
number or Unique Device Identifier (UDI). Include all of these
that apply.
(c) Date device received
(d) Manufacturer or representative/courier


UNIVERSITY OF WISCONSIN

POLICY & PROCEDURE

EFFECTIVE DATE

March 1994
ORIGINAL
 REVISION

OCTOBER 2017
PAGE 4
OF 4
POLICY #

1.37
ADMINISTRATIVE MANUAL
NURSING MANUAL
OTHER SURGICAL SERVICES
TITLE
MEDICAL DEVICES FDA TRACKING IN
PERIOPERATIVE AREAS


2. Implanted and/or explanted, complete the following information;

a) Fill out manufacturer's form and turn into the Operating Room control
station for USPS mailing.
b) Record the implanted and/or explanted device in the patient care record
and all information available for mandatory tracked items.

3. Device(s) removed from hospital inventory (i.e. given back to vendor,
exchanged for other goods, lent to other hospitals) require notification to the
Surgical Specialty Supervisor/Manager.

a) Surgical Services leaders or their designee (e.g., AFCH Service
Champions, Care Team Leaders) will be responsible for documenting the
disposition of the device in the FDA Tracking Logs.

IV. REFERENCES
Medical Device Tracking – Guidance for Industry and Food and Drug Administration,
Document issued on March 27, 2014

V. REVIEWED BY

A. Surgical Services Policy and Procedure Committee
B. Jill Barriere, Manager, AFCH Operating Room, RN, BSN, CNOR
C. Deb Ankowicz, Director of Risk Management MS, RN
D. Brenda Brookins, Materials Coordinator
E. Christine Schwartz, Inventory Control Supervisor CMRP
F. Linda Frederick, Surgical Services Supervisor, BSN, RN
G. Elizabeth Phillips, Surgical Services Supervisor, BSN, RN
H. Deb Zink, Surgical Services Supervisor, RN

VI. SIGNED BY

Anne Mork, MHCDS, MS, RN
Director, Surgical Services Department