missionemp10039_415_AD200082 Product Recalls - Mission Health

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Recalls, Product -- #200.082 Page: 2 Of: 4=====================================================================FDA Classification of Recalls:Class I Recalls ……… Dangerous or defective products that could cause serious health problems ordeath.Class II Recalls …….. Products that may cause a temporary health problem or medically reversibleadverse health consequences.Class III Recalls ……. Products that are unlikely to cause adverse health consequences but violateFDA regulations. An example is aspirin bottles containing 90 tablets insteadof 100, as stated on the product label.Market Withdrawal … Occurs when a product has a minor violation that would not be subject toFDA legal Action. The firm/supplier removes the product from the marketor corrects the violation.Medical Device Is issued in situations where a medical device may present an unreasonableSafety Alert ……….. risk of substantial harm. In some cases, these situations also are consideredrecalls.Source: U.S. Food and Drug AdministrationPROCEDURE:1. Initial recall notifications and medical device/equipment hazard reporting may be maileddirectly to Administration, Risk Management, specific departments and others. Upon directnotification to the department, recalls and advisories are to be forwarded to the MMRC. Afterevaluation by the MMRC, the recall may be forwarded to Biomed, the Pharmacy or, if amedical/surgical product, the MMRC will investigate, track, notify and distribute toappropriate units.2. Upon receipt of the recall by the MMRC/designee, Director of Pharmacy or Biomed/designee,will determine which hospital departments may have the involved product, and will notifythose departments. The Corporate Safety Department will keep appropriate records of therecall/advisory and the recommended action.3. The Recall Action Log (see Attachment A) will be sent to the contact person in thedepartment(s). When staff are notified of the recall/advisory, it is important that they respondquickly by thoroughly inventorying their department. The department(s) which may have theproduct will be responsible for implementing the following, as stated on the Recall Action Log.• Removal of product from service and return as stated on the Recall Action Log.• Modification of product; change in use instructions; stickers for packages etc.• Education of clinical staff of department and responsible area.• Completion of Recall Action Log and reporting back to Materials Management.• Note: If staff have no product to report from their department, this must be reportedas well to the Materials Management Recall Coordinator on the Recall Action Log.
Recalls, Product -- #200.082 Page: 3 Of: 4=====================================================================4. When defective product(s)/equipment are discovered in our facility before a recall has beenissued by the distributor or manufacturer, a copy of the Recall Process for Medical/SurgicalProducts (see Attachment B), available in each department, will be followed to direct staff ofthe process in handling the defective product(s)/equipment. The distributor or manufacturerwill immediately be contacted with this information for investigation to determine if thedefected product(s)/equipment are truly a recall.5. Clinical staff are notified if necessary for optimal course of action [i.e., education to staff,patient notification and/or selection of acceptable replacement product(s)].6. The MMRC/designee, Director of Pharmacy and Biomed will be responsible for contacting theproduct representative or agency regarding disposal of recalled product as returned byinstructions on the Recall Action Log.• Recalled medical/surgical products will be posted as recalled items and held in adesignated area in Materials Management until proper disposal or return.• Products classified as hazardous will be posted as such, impounded immediately and heldin a designated area in Materials Management until proper disposal or return.• Recalled equipment will be held by the Biomed Director/designee until proper disposalor return.• All recalled product or equipment pulled to be disposed of or returned should be clearlyposted on the product as “RECALL” by department. (This prevents theproduct/equipment from being mistaken as usable or being placed back into circulation.)• Recalled products which are collected by the MMRC will be credited, replaced, or anacceptable substitute will be purchased.7. The MMRC/designee and Director of Biomed/designee will complete the recall byimplementing the following as stated on the Recall Finding Results form (Attachment C):• Documenting appropriate departments/individuals who were notified about therecall/advisory to the best knowledge as directed by information findings and datahistory.• Documenting corrective action as stated by departments on completed Recall Action Logand reporting findings back to the product distributor or manufacturer representative oragency.• Noting where any additional documentation on the recall/advisory can be found.8. Director/Designee to insure sales representative removing recalled items from department willprovide appropriate information to MMRC by completing the “Removing Recalled Productsfrom Departments,” form (see Attachment D). All clinical areas using implants are responsiblefor maintaining an implant log for tracking processes.
Page 1: Administrative Policy and Procedure
Page 5 and 6: Attachment ARecalls, Product -- #20
Page 7 and 8: Attachment CRecalls, Product -- #20

missionemp10039_415_AD200082 Product Recalls - Mission Health

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