STERILE PROCESSING
subject to FDA inspection and regulation. For ISOs, registration with the FDA as a repairer of medical devices is voluntary. Thus, OEMs have an extra burden and cost associated with their repair activities. Virtually anyone with a license to do business in a state can provide medical instrument repair. There are no requirements for quality or ability to repair the device back to the OEM specifications. When an ISO repairs a product, there is no requirement for the ISO to label or mark the product as being repaired by them. The OEM’s name and product information remain on the product, thus should fail- ure of the product occur post-ISO repair, the customer likely will associate the product failure to the OEM and not the ISO.
Quality questions
“OEMs regularly find evidence of improper repair and repairs that do not meet their product specifications. In some cases, the improper repair could pose a risk to patient safety. As just one example, upon receiving a complaint from a hospital customer that a resectoscope used in ureteroscopy was failing because the electrode was being crushed when the surgeon tried to advance the electrode, the OEM was being blamed for poor quality. Upon investigation, it was discovered that an ISO had replaced the ceramic beak on the resectoscope. The ISO beak was not to the same specifications as the origi- nal OEM part. The ISO repair technician apparently was not aware of the critical nature of the part. Because the ISO beak was oversized, the electrode was catching on it and could not be advanced. The surgeon could not perform the procedure on the patient due to this. The patient was exposed to the OR
environment for longer than necessary increasing their risk for [surgical site infection] (American College of Surgeons Risk Factors for SSI 2018).
“I have witnessed power tools (e.g., saws, drills etc.) where
because the ISO did not have a control board for a newer model device, they substituted a control board from a previous model that did not provide the same functions to the user. The user hospital was not notified of this change by the ISO. One ISO reversed the cables on a flexible endoscope so that up was down and down was up.
Regulatory recommendations
“I believe that the FDA should classify instruments as general or complex. For complex instruments, the FDA should require full compliance from all companies that provide repair ser- vices. General instruments, due to the lower risk of improper repair, do not need to be regulated by the FDA. It should be up to the OEM whether it chooses to authorize and/or sell their components to an ISO. It should be the ISO’s sole responsibility to ensure that it meets OEM specifications for a repair, or it should notify the end user of the change they made. OEMs typically charge more for repair services versus an ISO; however, with the OEM the customer is assured of high quality and customer support on each repair. With an ISO, there is no guarantee that the repaired product meets the OEM specifications.”
Gregg Agoston, Vice President, Business Development, SPD Transformation Services, SpecialtyCare
United States Postal Service - Statement of Ownership, Management, and Circulation (Requester Publications Only) 1.
2. 3. 4. 5.
Publication Title: Healthcare Purchasing News Publication Number: 1098-3716 Filing Date: 9/19/22
Issue of Frequency: Monthly Number of Issues Published Annually: 12
6. Annual Subscription Price: Free to Qualified 7. Complete Mailing Address of Known Office of Publication (Not Printer): Endeavor Business Media, LLC, 2477 Stickney Point Road, Suite 221B, Sarasota, FL 34231 Contact Person: Laura Moulton; Telephone: 941/259-0859.
8. 9.
Complete Mailing Address of Headquarters or General Business Office of Publisher (Not Printer): Endeavor Business Media, LLC,30 Burton Hills Blvd., Ste. 185., Nashville, TN 37215
Full Names and Complete Mailing Addresses of Publisher, Editor, and Managing Editor - Publisher, Matthew Raynor; Editor, Rick Dana Barlow; Managing Editor: Scott Tomko; 2477 Stickney Point Road, Suite 221B, Sarasota, FL 34231(same for all)
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13. Publication Title: Healthcare Purchasing News
14. Issue Date for Circulation Data: September 2022 15. Extent and Nature of Circulation a. Total Number of Copies (Net press run)
b. Legitimate Paid and/or Requested Distribution (By Mail and Outside the Mail) (1) Outside County Paid/Requested Mail Subscriptions stated on PS Form 3541. (2) In-County Paid/Requested Mail Subscriptions stated on PS Form 3541.
(3) Sales Through Dealers and Carriers, Street Vendors, Counter Sales, and Other Paid or Requested Distribution Outside USPS
c. d.
(4) Requested Copies Distributed by Other Mail Classes Through the USPS Total Paid and/or Requested Distribution (Sum of 15b (1), (2), (3), and (4))
Nonrequested Distribution (By Mail and Outside the Mail) (1) Outside County Nonrequested Copies Stated on PS Form 3541 (2) In-County Nonrequested Copies Stated on PS Form 3541
(3) Nonrequested Copies Distributed Through the USPS by Other Classes of Mail
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e. f.
g. Total Nonrequested Distribution
Total Distribution (Sum of 15c and 15e) Copies not Distributed
h. Total (Sum of 15f and g) i.
Percent Paid and/or Requested Circulation (15c divided by 15f times 100)
16 Electronic Copy Circulation a.
Requested and Paid Electronic Copies b. Total Requested and Paid Print Copies c. d.
Average No. Copies Each Issue During Preceding 12 Months
36,057
26,337 0
77 0 26,415
6,324 0 0
2,879 9,203
35,618 439
36,057 74.16%
1,248
Total Requested Copy Distribution (Line 15f) + Requested/Paid Electronic Copies Percent Paid and/or Requested Circulation (Both Print & Electronic Copies)
27,663 36,866 75.04%
I certify that 50% of all my distribution copies (electronic and print) are legitimate requests or paid copies:
17. Publication of Statement of Ownership for a Requester Publication is required and will be printed in the: November 2022 issue of this publication.
18 Laura Moulton, Audience Development Manager Date: 9/19/22
I certify that all information furnished on this form is true and complete. I understand that anyone who furnishes false or mis- leading information on this form or who omits material or information requested on the form may be subject to criminal sanctions (including fines and imprisonment) and/or civil sanctions (including civil penalties).
No. Copies of Single Issue Published
Nearest to Filing Date 36,000
27,197 0
62 0 27,259
5,487 0 0
2,900 8,387
35,646 354
36,000 76.47%
1,305
28,564 36,951 77.30%
hpnonline.com • HEALTHCARE PURCHASING NEWS • November 2022 37
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