# Presentation: 295482

## Regulation of Reprocessing of SUD’s - An OEM Perspective

**MDUFMA Stakeholders Meeting**
**Tony Blank, Boston Scientific Corporation**
**December 3, 2003**

## Key Points

- Risk Classification of Reprocessed Devices
- Must somehow take into account unique device designs.
- Validation requirements
- Must be robust to assure reprocessed SUD’s are held to the same standards of Safety & Efficacy as OEM devices.
- Need for clarity persists
- Two recent examples: Recall Notification, Reprocessed Esophageal Stent.

## Key Points (cont.)

- Bundling of devices from multiple OEMs
- Different designs means different assessments of Substantial Equivalence/Safety & Efficacy.  Therefore, bundling is fundamentally without scientific merit.
- QSR is Not Optional
- Material Controls; Design Controls; CAPA; Records, Documents, & Change Controls; etc.
- PMR Guidance
- Same standard of Safety & Efficacy as PMA
- Post-Market Requirements
- Labeling/Promotional Statements subject to same requirements as all devices;
- Control of product to “maximum number” of reprocessings

## Risk Classification of Reprocessed Devices

- Because of the varied risks posed by varied individual designs, risk classification is NOT a category decision but a device-by-device, model-by-model decision.  (FDA’s own laboratories came to this conclusion in 2001, *Biomedical Instrumentation & Technology*; Sept./Oct. 2001, p. 321.)
- Therefore, the current scheme to identify devices for which additional premarket controls are required (e.g., premarket review of validation data) does not adequately assess risk and should be revised to account for design differences between devices.

## Validation Requirements

- Sound validation principals MUST be applied:
- Establish specifications for process inputs (i.e., contaminated devices)
- Acceptable types and levels of dirt (biological contamination, debris, etc.);
- Necessary environmental controls (temperature, humidity, time to cleaning, etc.);
- Specific design criteria (lumen sizes, port configurations, etc.);
- Construction details (amount/type of adhesives, materials of construction, etc.)

## Validation Requirements (cont.)

- Establish specifications for process outputs (i.e., finished medical devices)
- Acceptable types and levels of dirt (biological contamination, debris, etc.);
- Device performance specifications (bond strength, compliance, impedance etc.)
- Demonstration of Process Effectiveness and Consistency
- Package specifications (seal strength, barrier effectiveness, bust pressure, etc.)
- Demonstration of Process Effectiveness and Consistency
- In Sum...
- We believe the same standards should apply to the reprocessing of devices designed for single use.  Because devices were not designed for reuse, comprehensive scientific rigor must be applied when establishing cleaning, sterilization and performance validation requirements.

## Validation Requirements

**Dull**

**A Validated Process??**

**???**

## Needs Persist - Recall Notification

**PRODUCT**a) ETHICON brand surgical device. The product described on label is a Stapler, reload, TR35W, TR776, TCR 75, TCR 55, TRT75. Recall #Z-1257-03;b) ETHICON brand surgical device. The product described on label is a: 5mm Curved Shears, Scissors Grip Handle 14cm Item Code CS14C. Recall # Z-1258-03;...v) ETHICON brand surgical device. The product described on label is a: Needle, Ultra Veress. Recall # Z-1278-03.
**CODE**All codes.**RECALLING FIRM/MANUFACTURER**Recalling Firm: International Surgical Supply, Inc., Miami, FL, by e-mail on _**September 3, 2003**_. Manufacturer: MedSurg Solutions, Plymouth, MN. FDA initiated recall is ongoing.**REASON**Various Sterile Expired and Non-expired Ethicon brand surgical devices were _**resterilized without adequate validations and distributed**_.**VOLUME OF PRODUCT IN COMMERCE**1,355.

**The name “ETHICON” appears 22 times.  **
**Who is the manufacturer?  MedSurg Solutions!**

## Needs Persist - OBU Reprocessing

**Reprocessed Open But Unused (OBU) **
**Covered Esophageal Stent**

**An Effective Quality System??**

## Bundling Reprocessed SUDs from Multiple OEMs

- Different OEMs means Different Designs, Different Materials, and Different Manufacturing Specifications and thus...
- Different Risk Assessments
- Different Design Inputs/Outputs
- Different Validation Inputs/Outputs
- Different Assessments of S&E or SE
_***Conclusion***_
- Bundling from multiple OEMs lacks scientific merit
- and should not be allowed

## QSR is Not Optional

- Material Controls
- Expect Reprocessors to control all incoming materials (including used devices).  Includes detecting and appropriately accounting for changes.
- Design Controls
- Since Reprocessors do not have access to the OEM’s design specifications and are unaware of changes to the design specificationsvalidation must address such potential changes (e.g., assessments that assure that every single device reprocessed continues to meet validated design outputs).
- Etceteras...
***	******Whether a Reprocessor or an OEM, a robust and effective implementation of the Quality System Requirements is vital to the protection of patients.***

## PMR Guidance

**“****(B) In the case of a class III device referred to in subsection (a) that is a reprocessed single-use device:**
**...****.**
**(ii) Subject to clause (i), the provisions of this section apply to a report under subparagraph (A) to the same extent and in the same manner as such provisions apply to an application under paragraph (1).”**
_*In English*_
- PMR’s are to be evaluated to the same extent and held to the same standards as PMA’s.  Specifically, provide sufficient evidence to provide assurance of the safety and efficacy of the reprocessed device for its intended use (as designed and manufactured).
- Preapproval inspections
- Clinical Studies to establish safety and efficacy of the device to the maximum number of reprocessings

## Post Market Requirements

- Promotional Statements
- “Reprocessed in an FDA-approved facility”
- “Same as (or better than) original device”
- “FDA-approved 510(k)”
- “Tested/Inspected to a higher level of quality than original device”
- "The devices we send to hospitals are the same as those purchased from manufacturers, our studies show they're as clean or cleaner, they function the same and because we test 100 percent of them they'll work when the doctor opens them in the operating room." *- Bryan Sullivan, CFO; Sterilmed*
*	**Statements such as these constitute False and Misleading Labeling and is thus *_*Misbranding*_*.  *
*	**Entities which promulgate such claims must be held accountable like *_*any medical device manufacturer*_* should be.*

## Post Market Requirements

- Clearance/Approval incorporates specification of “maximum number of times” the device can be reprocessed and remain either substantially equivalent or safe and effective.
- Consequently, Reprocessors must demonstrate effective controls to...
- track the number of times a device has been reprocessed;
- remove devices from the market after the device has been reprocessed the identified maximum number of times; and
- ensure that reprocessed SUDs are returned to the initial purchaser (i.e., hospital) to limit potential for cross-contamination.

## Final Point - Patient Consent

- _Fact_
- Reprocessed SUD’s have been previously exposed to other, potentially infectious, biological environments before use on a patient and were never designed to facilitate effective cleaning, repackaging and resterilization (in contrast to devices designed for reprocessing). Thus, a reprocessed SUD must inherently pose a greater patient risk (compared to an original device).
- _Conclusion_
- Patients should be given the opportunity to choose whether or not they will consent to the use of a reprocessed SUD.