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FAST STATS


NEWSWIRE


A 5-minute MicroSurvey on treating physicians’ perspectives regarding the spread of measles and patient and caregiver sentiments included data sourced from 455 U.S. physicians,


distributed from across the nation and with a broad range of years in practice. The survey was conducted April 18-19, 2019.


of responding physicians say they’re getting more calls with questions about measles.


of physicians say patients are getting proactive about measles vaccination and its urgency.


say they hear more anxiety on measles vaccination from parents with newborns.


of physicians noted an increased spread of misinformation.


57% 61% 57% 41% 4%


of the physicians surveyed have personally treated patients with measles.


know of colleagues in their facility that have treated patients with measles.


know of colleagues in their community that have treated patients with measles.


13% 23% 36%


of physicians strongly anticipate that more communities will instill vaccination requirements.


oce no  . 6


UDI Update: FDA fi nalizes guidance for convenience kits The Food and Drug Administration an- nounced on April 25, its final guidance: niue evice dentifi cation onvenience Kits,” which the agency says gives its inter- pretation of the defi nition of convenience kit” for sole purposes of applying unique device identifi er  reuirements. FDA says the document clarifies the FDA’s policy related to UDI considerations for “medical procedure kits” and helps ensure that the exception for UDI labeling of devices within the immediate container of a convenience kit is applied in a way that provides adeuate identifi cation of devices through distribution and use. ccording to s   . a convenience kit is “two or more different medical devices packaged together for the convenience of the user.  said in the an- nouncement that the agency “interprets this to mean a device that contains two or more different medical devices packaged together and intended to remain packaged together and not to be replaced, substituted, repack- aged, sterilized, or otherwise processed or modifi ed before being used by an end user. What follows are some brief examples of what is contained in various types of con- venience kits for purposes of FDA’s unique device identifi cation system reuirements, including UDI labeling and data and sub- mission reuirements. etail fi rst aid it:  fi rst aid kit sold at retail that includes only devices—such as bandages, cold compresses, scissors, and an oral thermometer—packaged together is a convenience kit. t is a device that contains two or more different medical devices that are packaged together for the convenience of the user and intended to remain packaged together and not to be replaced, substi- tuted, repackaged, sterilized, or otherwise processed or modifi ed before being used by an end user. Therefore, the label of each individual device within the container is not required to bear a UDI, provided that a UDI is available on the label affi ed to the im- mediate container of the kit.  labeler may choose to market individual devices sepa- rately to the end user. n such cases, the label and device package of the individual devices that may be used to replenish or augment the fi rst aid kit must bear a  because they are not part of the convenience kit. onsterile orthopedic deice set: A collection of orthopedic devices comprises implants and reusable instruments that are all supplied non-sterile. ach of these devices is removed from its packaging to be placed into a sterilization tray for clean- ing and sterilization at some point prior to use, as intended by the labeler. nly a few


June 2019 • HEALTHCARE PURCHASING NEWS • hpnonline.com


of the implants in each set may be selected for implantation in a single procedure on a single patient. fter the procedure, the sets are replenished with different implants, replacing those used during the procedure. The sterilization tray, the replacement implants, the implants that were in the sterilization tray prior to the procedure and not chosen for surgical use, and the reusable instruments, are all sterilized for potential use in subseuent surgical cases. This is not a convenience kit because the devices are not intended to remain packaged together without undergoing sterilization before being used by an end user. Therefore, each device must comply with all applicable UDI labeling, data submission, and direct mark reuirements. Sinle use disposale medical procedure


it: A single use, disposable medical proce- dure kit, such as an anterior cruciate liga- ment  procedure kit, comprises sterile, single use instruments such as guide wires, drill tip guide pins, tunnel plugs, and a graft passer that are used for  reconstruction procedures. The kit comprises devices that are packaged and sealed in a single con- tainer, and the container is supplied sterile. The container is intended to remain sealed and the contents sterile until the contents are about to be used on a patient. ll the devices are used for a single procedure on a single patient, or, if unused after a single procedure on a single patient, disposed of without be- ing used because sterility has been compro- mised. This single use disposable medical procedure kit is a convenience kit because it is a device comprising individual devices packaged together for the convenience of the user and not intended to be replaced, sub- stituted, repackaged, sterilized, or otherwise processed or modifi ed before the devices are used by an end user. Therefore, the label of each individual device within the container is not required to bear a UDI, provided that a  is available on the label affi ed to the immediate container of the kit. Sterile it containin oth sinleuse


and reusale medical deices pacaed toether: A suture kit contains single-use sutures and reusable stainless-steel instru- ments, including forceps, needle holders, and scissors. The kit is supplied sterile, but after the initial procedure in which the single use device suture is consumed, the labeler intends that the instruments may be reused on different patients, which requires repro- cessing before each subseuent use. This is a convenience kit because the individual devices within the device are packaged to- gether for the convenience of the user and not intended to be replaced, not required to bear a UDI, provided that a UDI is avail- able on the label affi ed to the immediate


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