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14. Storage, Distribution and Installation


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14 STORAGE, DISTRIBUTION, AND INSTALLATION

INTRODUCTION
     Holding and Distribution Procedures
     Warehouse Storage
     Distribution Records
DEVICE INSTALLATION
EXHIBITS
     Finished Product Release Form
     Release To Finished Goods/Shipping
     Product Shipping Hold
     Release From Product Shipping Hold
     Partial List of Traceable Devices


INTRODUCTION

The device Quality System (QS) regulation covers the manufacture, storage (820.150), distribution (820.160) and installation (820.170) of finished devices. For manufacturers and importers, distribution is one of the most important steps in their quality system. After a product is distributed, a manufacturer rarely has direct control over the product or how it is used. Thus, it is important that controls be in place to assure that only correctly labeled, packaged and approved finished devices are distributed and, if necessary, installed.

Holding and Distribution Procedures

Section 820.160 requires that the purchase order be reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution. Manufacturers should have a program to reduce problems in this area. Marketing personnel should be adequately trained. Sales specification flyers and catalogs should be carefully written and kept current to reduce ordering problems. Incoming purchase orders should be checked and ambiguities and errors resolved. After receipt by appropriately trained personnel, orders should be reviewed immediately. If purchase orders are reviewed late in the manufacturing process or just before distribution, the value of the review may be significantly reduced. Where the customer includes specifications, each specified parameter should be checked against the corresponding parameter for the device. A checklist of device parameters may be a helpful tool for this review and should be filed with, or keyed to, the purchase order.

The QS regulation (820.60), Identification, requires manufacturers to set up and maintain identity control of their products from component receipt, production, distribution and through installation to prevent mixups. The regulation also requires that written procedures be provided for control and distribution of finished devices (820.160). The purpose of this requirement is to assure that only approved devices are distributed. Each manufacturer should determine what written procedures are needed to assure that only "approved for release" devices are distributed from the manufacturer. If a manufacturer believes written procedures will not contribute to assuring that only Aapproved for release@ devices are distributed by their manufacturer, they should be able to defend their decision. For example, the control is integrated into the activities required to package the device or to complete the device history record. This flexibility is allowed by section 820.5, Quality system, of the QS regulation.

Many manufacturers mark their released finished devices or identify them by location or packaging so that a simple visual check is sufficient to indicate whether the product is acceptable to release for distribution. For example, radiation-emitting electronic products are subject to a performance standard. The application of the certification label is often the last step in approving product release for distribution, and this label is used to distinguish such devices. After final release, the crating of large equipment is a very distinguishing feature. These types of operations may preclude the need for a separate written procedure.

For interstate contract sterilization, 21 C.F.R. section 801.150(e) requires a written agreement between the parties which details the necessary procedures to help prevent the erroneous release of packaged and labeled "sterile" but not yet sterilized devices that appear to be, but are not, ready for release. Regardless of whether 801.150(e) applies, the QS regulation requires controls, as necessary, to prevent mixups in complex situations such as contract sterilization. For consistency, a contract as described by 801.150(e) is commonly used by manufacturers for interstate and intrastate shipments. Compliance with such a contract satisfies the applicable GMP requirements. (See Chapter 10, Purchasing and Acceptance Activities, and Compliance Policy Guide 7382.830B for details.)

Sometimes manufacturers need to ship "finished devices" that have not been officially released because the final test data is not yet available. The critical factor is that the device still remains under the manufacturer=s control. The most common example occurs when a manufacturer is waiting for the results from biological indicator tests. FDA permits manufacturers to ship such devices under quarantine to their own controlled warehouses where the devices may be readily recalled prior to any use, if the need arises. Manufacturers should not ship non-released devices to routine distributors or anyone outside of their direct control. Non-released products or products on "hold" for any quality reason should be controlled to prevent release. A suitable control is quarantine with a label on the units, pallets, etc., to indicate their status.

Warehouse Storage

Storage should always be done under systematic, orderly conditions (820.150). Manufacturers should use a first-in, first-out (FIFO) distribution system when fitness for use of a device deteriorates over time (820.150).

When a controlled environment is necessary to prevent abnormal deterioration, the environment should be specified, controlled, and monitored according to sections 820.70(c) (see Chapter 6, Buildings and Environment). Environmental specifications, such as storage temperature, should be included in the device master record.

The storage and handling of devices to be distributed may involve extensive activities (820.140 and 820.150). For example, damaged, recalled or returned devices should be suitably marked and segregated from devices acceptable for release (820.86). Returned devices should be handled and stored such that the cause of failure or other useful information is not destroyed. Returned defective devices should be formally investigated according to 820.100 Corrective and Preventive Action and any associated complaints investigated according to 820.198. Therefore, manufacturers will need controls to assure that returned defective devices do not dead-end in the warehouse, but are expeditiously routed to the appropriate department for evaluation, investigation, conclusions and follow-up (see Chapter 15, Complaint Files).

Distribution Records

Quality System section 820.184, Device History Record (DHR), requires manufacturers of devices to maintain basic records for:

Section 820.160, Distribution, requires the following records:

Some of the above information necessary for the distribution records is a duplicate of Device History Record (DHR) requirements. These duplications may be copied or transferred electronically from the DHR. If appropriate, a manufacturer may combine the records by adding the distribution information to the DHR.

In addition to the above requirements, manufacturers of implantable devices and life sustaining devices, the failure of which during use could result in significant injury to the user, are required to establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and, where appropriate, components (820.65). A partial list of traceable devices that meet this definition is printed at the end of this chapter.

Distribution records may be the same as, or part of, the normal business records. Generation of a separate record is not required unless the business records are not readily available, e.g., not maintained at the same establishment as the device history record and not readily retrievable electronically. Many manufacturers, also keep distribution records for billing and market survey purposes.

Manufacturers of radiological electronic products listed in 21 CFR 1002.1, Record and Reporting Requirements By Product, shall maintain distribution records that will enable them to trace specific products or production lots to distributors, or to dealers in those instances in which the manufacturer distributes directly to dealers (See 21 CFR 1002.30, Records to be Maintained by Manufacturers).

Distribution records shall be kept for a period of time equivalent to the design life and expected life of the device, but in no case less than two years from the date of release for commercial distribution by the manufacturer [820.180(b)]. The intent of this requirement is support for potential repairs, corrective actions and recalls. Each manufacturer should make a prudent decision whether to discard records or keep all, or part, of them for a longer period. When requested, distribution records shall be made available to FDA investigators for review and copying during normal business hours.

DEVICE INSTALLATION

Section 820.170 on installation requires that each manufacturer establish and maintain adequate installation and inspection instructions and, where appropriate, testing procedures. The purpose of this requirement is to ensure that the device is properly installed and will perform as intended after installation. This regulation applies to medical device systems and complex devices that require set up and adjustment at the location where they are to be used. For example, before a diagnostic x-ray machine can be used, it has to be installed and adjusted and the performance checked. Cardiopulmonary bypass machines also require set up and adjustment at the user location. Manufacturers of such devices shall:

These instructions and procedures for proper installation by the manufacturer's representative, user, or third party (820.170) shall include instructions on how to determine that the installed device is safe, performing satisfactorily and ready for use. Safety checks at installation refer to safety aspects directly related to the installation and setup activities and not to intrinsic safety features that have already been checked during final acceptance testing at the factory.

The instructions and procedures shall be distributed with the device or otherwise made available to the person installing the device. Such procedures and instructions are part of the device master record and generally include a checklist for the installer to make certain that all necessary installation and checkout activities have been performed correctly. The installer should complete the checklist. If available to the manufacturer, the filled-in checklist or other installation records are part of the device history record.

Installation and servicing are related activities. Therefore, see Chapter 16, Servicing, for more information.


EXHIBITS

Various forms to show that devices are finished and may be released or stopped from release and a list of some traceable devices are briefly described below and then exhibited.

Finished Product Release Form

This exhibit shows an example of a finished product release form which is actually a checklist for the manufacturing and QC departments of an in vitro diagnostic manufacturer to show that all required processes have been completed. The checklist acts as a reminder of the acceptance forms that are needed for a product and has space for the manufacturing and QC people to indicate that these forms have been completed and reviewed. Finally there is space for the designees to approve or disapprove the lot for release and for comments, if needed.

Release To Finished Goods/Shipping

This exhibit is a release form as described above except that it is for various hardware products. The employee writes in the specification for the product being released.

Product Shipping Hold

This exhibit is an example of a form used to stop the shipping of a finished device for reasons related to safety, performance, reliability, regulatory compliance, or other quality requirements.

Release From Product Shipping Hold

This is a form used to release a finished device from a stop shipment order. Because stop orders are always significant, this release form requires a signature by key management.

Partial List of Traceable Devices

This exhibit lists many of the devices for which a manufacturer must adopt a method of device tracking and the citation to 21 C.F.R. for the device.

It is required that implantable devices and life sustaining devices, whose failure during use as described on the label, could result in significant injury to the user, establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices. Where appropriate, this traceability rule also applies to components. These procedures should facilitate corrective action. This identification should be documented in the device history record. Many of these devices were formerly called critical devices.



FINISHED PRODUCT RELEASE

Form No.

Rev.

Sheet 1 of 1

Form Approved by:

Date
ECN notes:
Title: AMYLASE SET
Packaging lot numberCircle one CATALOG Number AM-389-01

AM-389-02

The device history documents below were reviewed by
6 Circle one form number in 2, 5 & 7 below.
MFGQC
1. Form # 9926Product flow sheet
2. Form # 1077 or 1078Iodine solution
3. Form # 1082Substrate solution
4. Form # 1083Substrate tube filling sheet
5. Form # 1084 or 1085Iodine filling sheet
6. Form # 1086Packaging record
7. Form # QC-PP-07 or QC-PP-01 Finished device specification
Comments
Sign. MFG Designee APP. Yes or No
Comments
Signature QC Designee Approved Yes or No


RELEASE TO FINISHED GOODS/SHIPPINGForm # Release-110 Rev. BSheet 1 of 1
Form Approved by: Date 4-15-1974
ECN notes:
Type of Product: [ ] Cable [ ] Instrument [ ] Spare/Replacement part/assembly
PRODUCT NAMEPart Number Serial / Lot Number
Inspection Specification Number Revision
PRODUCT STATUS Circle yes or no 9
1. Final inspection complete per standards set forth in the QC manual and device inspection specification ? YESNO
2. Device history record packet present ? YESNO
If the answer to 1 or 2 is NO, return lot to Production.
3. Has Final Inspection performed a simulated use test ? YESNO
4. An identified final test data sheet is with the unit ? YESNO
Comments
Signature QC Designee Approved YESNO
Quantity Released Date


HOLD NUMBER:DATE:
PRODUCT SHIPPING HOLD

BY QUALITY ASSURANCE DEPARTMENT

The product listed below is on SHIPPING HOLD and under NO circumstances is to be shipped from the factory or any field office without the written approval of the Director, Quality Assurance.
PRODUCT:
HOLD STARTING DATE:
CLASSIFICATION OF HOLD
[ ] EFFICACY

[ ] RELIABILITY

[ ] STERILITY

[ ] OTHER (describe)

[ ] SAFETY

[ ] REGULATORY COMPLIANCE

[ ] GOOF UP

REASON FOR HOLD:
ACTION REQUIRED BEFORE RELEASE:
MDR/RECALL NOTES:
Sign., DIRECTOR, QUALITY ASSURANCE
DISTRIBUTION:
[ ] Manager, Shipping Department

[ ] National Field Manager

[ ] General Manager

[ ] Controller

[ ] V.P. Corporate (if s/e problem)

[ ] Director, Manufacturing

[ ] Division President

[ ] Director, R & D

[ ] Director, Marketing

[ ] V.P. International (if int'l sales)


HOLD NUMBER:DATE:
RELEASE FROM PRODUCT SHIPPING HOLD

BY QUALITY ASSURANCE DEPARTMENT

The product listed below is RELEASED from SHIPPING HOLD.
PRODUCT:
HOLD RELEASE DATE:
REASON FOR RELEASE:
MDR/RECALL NOTES:
Sign., DIRECTOR, QUALITY ASSURANCE
DISTRIBUTION:
[ ] Manager, Shipping Department

[ ] National Field Manager

[ ] General Manager

[ ] Controller

[ ] V.P. Corporate (if S/E)

[ ] Director, Manufacturing

[ ] Division President

[ ] Director, R & D

[ ] Director, Marketing

[ ] V.P. International (if Int'l sales)


Partial List of Traceable Devices

CFR CiteClassification Name of Device
PART 868 -- ANESTHESIOLOGY DEVICES
868.1200Indwelling blood oxygen partial pressure (PO2) analyzer
868.2375Breathing frequency monitor
868.5090Emergency airway needle
868.5160(a)Gas machine for anesthesia
868.5240Anesthesia breathing circuit
868.5400Electroanesthesia apparatus
868.5440Portable oxygen generator
868.5470Hyperbaric chamber (Monoplace)
868.5610Membrane lung for long term pulmonary support
868.5650Esophageal obturator
868.5720Bronchial tube
868.5730Tracheal tube
868.5740Tracheal/bronchial differential ventilation tube
868.5750Inflatable tracheal tube cuff
868.5800Tracheostomy tube and tube off
868.5810Airway connector
868.5830Autotransfusion apparatus
868.5895Continuous ventilator
868.5905Noncontinuous ventilator (IPPB)
868.5915Manual emergency ventilator
868.5925Powered emergency ventilator
868.5935External negative pressure ventilator
PART 870 -- CARDIOVASCULAR DEVICES
870.1025Arrhythmia detector and alarm
870.1330Catheter guide wire
870.1360Trace microsphere
870.1750External programmable pacemaker pulse generator
870.1800Withdrawal-infusion pump
870.3250Vascular clip
870.3260Vena cava clip
870.3300Arterial embolization device
870.3375Cardiovascular intravascular filter
870.3450Vascular graft prosthesis of less than 6 millimeters diameter
870.3460Vascular graft prosthesis of 6 millimeters and greater diameter
870.3470Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoro-ethylene
870.3535Intra-aortic balloon and control system
870.3545Ventricular bypass (assist) device
870.3600External pacemaker pulse generator
870.3610Implantable pacemaker pulse generator
870.3620Pacemaker lead adaptor
870.3650Pacemaker polymeric mesh bag
870.3670Pacemaker charger
870.3680Cardiovascular permanent or temporary pacemaker electrode
870.3700Pacemaker programmers
870.3710Pacemaker repair or replacement material
870.3800Annuloplasty ring
870.3850Carotid sinus nerve stimulator
870.3925Replacement heart valve
870.4320Cardiopulmonary bypass pulsatile flow generator
870.4350Cardiopulmonary bypass oxygenator
870.4360Nonroller-type cardiopulmonary bypass blood pump
870.4370Roller-type cardiopulmonary bypass blood pump
870.5200External cardiac compressor
870.5225External counter-pulsating device
870.5300DC-defibrillator (including paddles)
870.5550External transcutaneious cardiac pacemaker (noninvasive)
---Percutaneous transluminal coronary angioplasty (PTCA) balloon dilation catheter
---Automatic implanted cardioverter defibrillator system
PART 872 -- DENTAL DEVICES
872.3640Endosseous implant
PART 874 -- EAR, NOSE, AND THROAT DEVICES
872.3620Ear, nose and throat synthetic polymer material
874.3695Mandibular implant facial prosthesis
874.3730Laryngeal prosthesis (Taub design)
874.3820Emdolmphatic shunt
874.3850Endolymphaic shunt tube with valve
874.3930Tympanotomy tube with semipermeable membrane
---Ear, nose, throat natural polymer-collagen material
PART 876 -- GASTROENTEROLOGY-UROLOGY DEVICES
876.3350Penile inflatable implant
876.5270Implanted electrical urinary continence device
876.5540A-V shunt cannula
876.5630Peritoneal dialysis system and accessories
876.5820Hemodialysis system and accessories, dialysate concentrate, hollow fiber capillary dialyzers, disposable dialyzers, high permeability dialyzers, parallel flow dialyzers, single coil dialyzers, twin coil dialyzers, single needle dialysis set, dialysate delivery systems
876.5870Sorbent hemoperfusion system
876.5880Isolated kidney perfusion and transport system and accessories
876.5955Peritoneo-venous shunt
46 FR 7566 (1/23/81)Urethral sphincter prosthesis
46 FR 7566 (1/23/81)Urethral replacement
PART 878 -- GENERAL AND PLASTIC SURGERY DEVICES
42 FR 63474 (12/16/77)Absorbable surgical sutures
42 FR 63474 (12/16/77)Nonabsorbable surgical sutures
879.4520Polytetrafluoroethylene (Teflon) injectable
878.3300Surgical mesh
878.3500Polytetrafluoroethylene with carbon fibers composite implant material
878.3530Inflatable breast prosthesis
878.3540Silicone gel-filled breast prosthesis
---Implanted mammary prosthesis of composite saline and gel-filled design
878.3610Esophageal prosthesis
878.3720Tracheal prosthesis
878.4300Implantable clip
878.4750Implantable staple
---Maxillofacial prosthesis
PART 880 -- GENERAL HOSPITAL AND PERSONAL USE DEVICES
880.5130Infant radiant warmer
880.5400Neonatal incubator
880.5410Neonatal transport incubator
880.5725Infusion pump
---Implanted infusion pump
PART 882 -- NEUROLOGICAL DEVICES
882.5030Methyl methacrylate for aneurysmorrhaphy
882.5150Intravascular occluding catheter
882.5200Aneurysm clip
882.5225Implanted malleable clip
882.5250Burr hole cover
882.5300Methyl methacrylate for cranioplasty
882.5320Preformed alterable cranioplasty plate
882.5330Preformed nonalterable cranioplasty plate
882.5360Cranioplasty plate fastener
882.5550Central nervous system fluid shunt and components
882.5820Implanted cerebellar stimulator
882.5830Implanted diaphragmatic/phrenic nerve stimulator
882.5840Implanted intracerebral/subcortical stimulator for pain relief
882.5850Implanted spinal cord stimulator for bladder evacuation
882.5860Implanted neuromuscular stimulator
882.5870Implanted peripheral nerve stimulator for pain relief
882.5880Implanted spinal cord stimulator for pain relief
882.5880Epidural spinal electrode
882.5900Preformed craniosynostosis strip
882.5910Dura substitute
882.5950Artificial embolization device
---Lyophilized human (cadaver) dura mater
---Stabilized epidural spinal electrode
---Implanted intracranial pressure monitor
---Totally implanted spinal cord stimulator for pain relief
PART 884 -- OBSTETRICAL AND GYNECOLOGICAL DEVICES
884.5360Contraceptive intrauterine device (IUD) and introducer
884.5380Contraceptive tubal occlusion device (TOD) and introducer
PART 886 -- OPHTHALMIC DEVICES
886.3300Absorbable implant (scleral buckling method)
886.3400Keratoprosthesis
886.3600Intraocular lens
886.3920Eye valve implant
PART 888 -- ORTHOPEDIC DEVICES
888.3000Bone Cap
888.3010Bone fixation cerclage
888.3020Intramedullary fixation rod
888.3025Passive tendon prosthesis
888.3027Polymethyllmethaccrylate (PMMA) bone cement
888.3030Single/multiple component metallic bone fixation appliance and accessories
888.3040Smooth or threaded metallic bone fixation fastener
888.3050Spinal interlaminal fixation orthosis
888.3060Spinal intervertebral body fixation orthosis
888.3100Ankle joint metal/composite semi-constrained cemented prosthesis
888.3110Ankle joint metal/polymer semiconstrained cemented prosthesis
888.3120Ankle joint metal/polymer non-constrained cemented prosthesis
888.3150Elbow joint metal/metal or metal/polymer constrained cemented prosthesis
888.3160Elbow joint metal/polymer semi-constrained cemented prosthesis
888.3170Elbow joint radial (hemi-elbow) polymer prosthesis
888.3180Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis
888.3200Finger joint metal/metal constrained uncemented prothesis
888.3210Finger joint metal/metal constrained cemented prosthesis
888.3220Finger joint metal/polymer constrained cemented prosthesis
888.3230Finger joint polymer constrained prosthesis
888.3300Hip joint metal constrained cemented or uncemented prosthesis
888.3310Hip joint metal/polymer constrained cemented or uncemented prosthesis
888.3320Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis
888.3330Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis
888.3340Hip joint metal/composite semi-constrained cemented prosthesis
888.3350Hip joint metal/polymer semi-constrained cemented prosthesis
888.3360Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis
888.3370Hip joint (hemi-hip) acetabular metal cemented prosthesis
888.3380Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis
888.3390Hip joint femoral (hemi-hip metal/polymer cemented or uncemented prosthesis
888.3400Hip joint femoral (hemi-hip) metallic resurfacing prosthesis
888.3410Hip joint metal/polymer semi-constrained resurfacing cemented prosthesis
888.3480Knee joint femorotibial metallic constrained cemented prosthesis
888.3490Knee joint femorotibial metal/composite non-constrained cemented prosthesis
888.3500Knee joint femorotibial metal/composite semi-constrained cemented prosthesis
888.3510Knee joint femorotibial metal/polymer constrained cemented prosthesis
888.3520Knee joint femorotibial metal/polymer non-constrained cemented prosthesis
888.3530Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis
888.3540Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis
888.3550Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis
888.3560Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
888.3570Knee joint femoral (hemi-knee) metallic uncemented prosthesis
888.3580Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis
888.3590Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis
888.3640Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis
888.3650Shoulder joint metal/polymer non-constrained cemented prosthesis
888.3660Shoulder joint metal/polymer semi-constrained cemented prosthesis
888.3680Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis
888.3690Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis
888.3720Toe joint polymer constrained prosthesis
888.3730Toe joint phalangeal (hemi-toe) polymer prosthesis
888.3750Wrist joint carpal lunate polymer prosthesis
888.3760Wrist joint carpal scaphoid polymer prosthesis
888.3770Wrist joint carpal trapezium polymer prosthesis
888.3780Wrist joint polymer constrained prosthesis
888.3790Wrist joint metal constrained cemented prosthesis
888.3800Wrist joint metal/polymer semi-constrained cemented prosthesis
888.3810Wrist joint ulna (hemi-wrist) polymer prosthesis


Updated 1/1/1997

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