This guidance document is being distributed for comment purposes only.
Draft released for comment on February 8, 2000
U.S. Department of Health and Human
Services Division of Dental, Infection Control, |
Comments and suggestions regarding this document should be submitted by April 11, 2000 to the Docket No. 00D-0053, Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, (HFA-305), Room 1061, Rockville, MD 20852.
World Wide Web/CDRH home page at http://www.fda.gov/cdrh/reuse/1156.pdf or CDRH Facts on Demand at 1-800-899-0381 or 301-827-0111, specify number 1156 when prompted for the document shelf number.
Barbara C. Zimmerman
Center for Devices and Radiological Health (HFZ-340)
Food and Drug Administration
9200 Corporate Blvd.
Rockville, MD 20850
301-443-8517
The practice of reprocessing devices that are intended for
single-use (SUDs) began in hospitals in the late 1970s. Since that time, the
practice of reprocessing and reusing SUDs has become widespread. FDA has not regulated
original equipment manufacturers (OEMs), third parties, and hospitals that engage in
reprocessing SUDs in the same manner. In particular, to date, FDA has enforced
existing premarket submission requirements only against OEMs. FDAs premarket
review of an OEMs device labeled for single-use does not ordinarily address whether
reprocessing and reuse of such a device would present a risk to the public health. The public health risk presented by a reprocessed SUD varies. Some devices, which are low risk when used only one time, may present an increased risk to the patient upon reprocessing. Other SUDs are low risk when used for the first time and remain low risk after reprocessing, provided that the reprocessor conducts cleaning and sterilization/disinfection of the SUD in an appropriate manner. Other SUDs, however, cannot be reprocessed safely and should not be reprocessed and reused under any circumstances. FDA is proposing to prioritize its enforcement of premarket requirements for reprocessed SUDs on the basis of the risk that is likely to be posed by the reuse of the device. This guidance document describes the factors the agency will consider to determine the level of risk associated with these devices and the way those factors will be applied to determine whether the risk is high, moderate, or low. |
__________________
1This document is intended to provide guidance. It
represents the Agencys current thinking on this topic. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the requirements of the
applicable statute, regulations or both.
This document describes the process FDA would use to
categorize the risk of SUDs that are reprocessed. The process, called the Review
Prioritization Scheme (RPS), assigns risk categories to frequently reprocessed SUDs. The
process itself is illustrated through flow charts in Appendix 1 and
the risk categories assigned through the process to frequently reprocessed SUDs are listed
in Appendix 2. FDA anticipates using the RPS in the future in response to requests from the public on the category of a reprocessed SUD not listed in Appendix 2. Such requests should be directed, in writing, to the contact noted in the Preface. FDA will periodically publish a revised list of categorized devices based upon these requests. The RPS assigns an overall risk to each SUD by addressing the risk of infection and the risk of inadequate performance following reprocessing. The FDA intends to utilize the overall risk level to prioritize the enforcement of premarket submissions for these devices. Enforcement priorities for reprocessed SUDs are further described in the companion draft guidance entitled: "Enforcement Priorities for Single-Use Devices Reprocessed by Third-Parties and Hospitals." FDA wants to clarify that neither of these guidance documents change the classification of devices under section 513 of the Federal Food, Drug, and Cosmetic Act or establish some system of classification outside that statutory process. The risk prioritization scheme is intended to help FDA and stakeholders determine the level of risk associated with the reuse of single use devices and the enforcement strategy guidance presents FDAs current thinking on the time table it will use to phase in the enforcement of regulatory requirements for third parties and hospitals that may intend to reprocess these products. FDA is seeking input from users, original equipment manufacturers (OEMs), reprocessors, and the general public about this proposed approach for categorizing risk. The attached list in Appendix 2 of this draft RPS guidance identifies frequently reprocessed SUDs and their risk categorization. We acknowledge that this list may be incomplete or that the grouping of devices based on current classification regulations may be too broad. FDA will consider any SUD not on the current list or subsequently revised lists to be one that poses a high risk if it is reprocessed. FDA is soliciting public comment on the list and may revise the factors to categorize risk and the category of risk assigned to specific devices based upon the comments. After receiving comments on this draft guidance, FDA will issue a final guidance. On December 10, 1999 FDA published an earlier version of this draft document on its Website and recently issued a Federal Register notice announcing the availability of the that earlier version. This draft guidance replaces the earlier version in its entirety. |
This draft RPS guidance IS applicable to
third party and hospital reprocessors of SUDs. This draft guidance DOES NOT apply to:
FDA is aware that hospitals may not be the only health care facilities that reprocess devices labeled for single use. At this time, the agency is limiting its focus to SUD reprocessing by third party and hospital reprocessors. In the near future, FDA intends to examine whether it should include other establishments that may reprocess SUDs. |
____________________
2For the purpose of this draft guidance, a hospital is
defined as an acute health care facility.
The RPS identifies two types of risks that arise as a result
of using a reprocessed SUD: (1) the risk of infection; and (2) the risk of inadequate or
unacceptable device performance following reprocessing. Based on the risk of infection and
inadequate device performance, the scheme places SUDs in overall risk categories of low,
moderate, or high. As noted above, these risk categories will be used in establishing
FDAs enforcement priorities and periods of enforcement discretion for premarket
requirements. The worksheet and flowcharts attached (Appendix 1) to this guidance are the tools that FDA has used when applying the RPS. It is important to note that many of the questions asked in the flowcharts may require subjective responses. Despite the possibility of different interpretations, FDA has tried to make consistent categorizations across all SUD types. Flowchart 1: Evaluating the Risk of Infection (Appendix 1) One of the FDAs primary concerns is the risk of disease transmission during reuse of a reprocessed SUD. For a reusable device, the OEM provides the user with validated step-by-step reprocessing instructions or the methods to reprocess for reuse are commonly known and accepted. However, the OEM of a single-use device does not consider safety and effectiveness issues related to reprocessing the device for reuse. Flowchart 1 evaluates the risk of infection posed by reuse of a SUD following reprocessing. FDA considers all implantable SUDs to be high risk. Implantable devices are defined in 21 CFR Part 860.3(d). Flowchart 1 pertains only to non-implantable devices. |
Question 1: Is the SUD a non-critical device? |
||
The chart asks how the device will contact the patient, or in some cases, the user or health care worker, by applying the definitions of the Spaulding criteria3 for critical, semi-critical, and non-critical devices. |
A non-critical device is a device that is intended to make topical contact and not penetrate intact skin. A non-critical device presents a low risk of disease transmission when reprocessed and reused. A semi-critical device is a device that is intended to contact intact mucous membranes and not penetrate normally sterile areas of the body. A semi-critical device presents a greater risk of disease transmission than a non-critical device. A critical device is a device that is intended to contact normally sterile tissue or body spaces during use and presents the greatest risk of disease transmission.
|
______________________
3Spaulding, E.H. 1972. Chemical disinfection and
antisepsis in the hospital. J. Hosp. Res., 9, 5-31.
Question 2: Does postmarket information suggest that using the reprocessed SUD may present an increased risk of infection when compared to the use of a SUD that has not been reprocessed? | ||
If the device were determined to be critical or semi-critical, FDA would evaluate existing postmarket data (e.g., published data, laboratory reports, reports to FDA) to determine if the reprocessed SUD may present an increased risk of infection when compared to the use of a SUD that has not been reprocessed. FDA believes that the existence of significant adverse postmarket data is a compelling reason for concern and, therefore, FDA would consider the device to be high risk.
|
Question 3: Does the SUD include features that could impede thorough cleaning and adequate sterilization/disinfection? | ||
Some design features, such as narrow lumens and interlocking parts, can harbor debris that cannot be readily accessed and removed during cleaning unless the device can be disassembled or otherwise serviced and all surfaces of the devices exposed for manual cleaning. If a device cannot be adequately cleaned, terminal processing to disinfect or sterilize the device will not be successful and the SUD presents a greater risk of disease transmission. If a device does not incorporate any of these hard to clean features, then the SUD presents a low risk of disease transmission.
|
Question 4: Does a reusable device exist that has an equivalent design and the same intended use as the SUD? | ||
In some circumstances, there will be cleared, approved, or exempt reusable devices (including designs with problematic construction or materials features) that are equivalent to a SUD with the same intended use. In this case, the risk is diminished because it is evident that cleaning and sterilization/disinfection can be accomplished with the reprocessed SUD by using techniques directed by labeling for the reusable device.
|
Question 5: Are there recognized consensus performance standards, performance tests recommended by the OEM, or a CDRH guidance document that may be used to determine if the SUD has been adequately cleaned and sterilized/disinfected? | ||
FDA has recognized numerous domestic and international consensus standards that may be used for design and performance aspects of the reprocessed SUD. The list of FDA-recognized standards is available on FDAs website www.fda.gov/cdrh/modact/recstand.html. OEM-recommended performance tests (e.g., manufacturer-developed test, standards that are not recognized) may also be applicable. In addition, there are CDRH guidance documents on FDAs website www.fda.gov/cdrh/guidance.html, which may include specifications, test protocols, and acceptance criteria.
|
Question 6: Is this a semi-critical device? | ||
|
Flowchart 2:
Risk of Inadequate Performance (Appendix 1) Another one of FDAs primary concerns is the risk of inadequate performance during reuse of a reprocessed SUD. For a reusable device, the OEM validates that the device will perform without failure for the number of times it is labeled to be reused. However, a manufacturer of a SUD validates that the SUD will perform without failure for only one use. In Flowchart 2, we evaluate the risk of inadequate performance posed by reuse of a SUD following use and reprocessing. FDA considers all implantable SUDs to be high risk. Implantable devices are defined in 21 CFR Part 860.3(d). Flowchart 2 pertains only to non-implantable devices. |
||
Question 1: Does postmarket information suggest that using the reprocessed SUD may present an increased risk of injury when compared to the use of an SUD that has not been reprocessed? |
||
FDA evaluates existing postmarket data (e.g., published data, laboratory reports, reports to FDA) to determine if the reprocessed SUD may present an increased risk of injury when compared to the use of a SUD that has not been reprocessed. FDA believes that existence of significant adverse postmarket data is a compelling reason for concern and, therefore, would consider the device to be high risk. FDA does not consider the absence of relevant information to be either evidence of increased risk or proof of safety.
|
Question 2: Could failure of the device cause death, serious injury, or permanent impairment? | ||
For purposes of risk categorization associated with inadequate performance, Flowchart 2 distinguishes between those SUDs whose failure could cause death, serious injury, or permanent impairment and those SUDs whose failure would cause less severe harm.
|
Question 2a: Are there recognized consensus performance standards, performance tests recommended by the OEM, or a CDRH guidance document that may be used to determine if the performance of the SUD has been altered due to reprocessing and use? | ||
FDA has recognized numerous domestic and international standards that may be used for design and performance aspects of the reprocessed SUD. The list of FDA-recognized standards is available on FDAs WEBsite. OEM-recommended performance tests (e.g., manufacturer-developed tests, standards that are not recognized) may also be applicable. In addition, there are CDRH guidance documents on FDAs website, which may include specifications, test protocols, and acceptance criteria.
|
Question 2b: Can visual inspection determine if performance has been affected? | ||
Visual, critical failure of the device may be self-evident before or during use of the device. Measures can then be implemented to correct the failure.
|
Question 3: Does the SUD contain any materials, coatings, or components that may be damaged or altered by a single use or by reprocessing and/or resterilization/disinfection in such a way that the performance of the device may be adversely affected? | ||
Materials, coatings, or components may be damaged or altered by a single use or by reprocessing. For example, battery life, material strength or flexibility, lubrication, and antimicrobial coatings may be adversely affected.
|
Question 4: Are there recognized consensus performance standards, performance tests recommended by the OEM, or a CDRH guidance document that may be used to determine if the performance of the SUD has been altered due to reprocessing and use? | ||
FDA has recognized numerous domestic and international standards that may be used for design and performance aspects of the reprocessed SUD. The list of FDA-recognized standards is available on FDAs WEBsite. OEM-recommended performance tests (e.g., manufacturer-developed tests, standards that are not recognized) may also be applicable. In addition, there are CDRH guidance documents on FDAs website, which may include specifications, test protocols, and acceptance criteria.
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Question 5: Can visual inspection determine if performance has been affected? | ||
Visual, critical failure of the device may be self-evident before or during use of the device. Measures can then be implemented to correct the failure
|
After determining the risk of infection from Flowchart 1 and the risk of inadequate performance from Flowchart 2, the worksheet in Appendix 1 is
used to determine the overall risk presented by reprocessing the SUD. Step-by-step
instructions for using the worksheet follow:
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FDA is providing 3 examples of how the RPS can be used to assess the overall risk of a reprocessed SUD. The headings for the examples note the risk category, the generic type of device, and, in parentheses, the FDA classification regulation number and internal three-letter product codes assigned by FDA. The questions in the examples are paraphrased from the flowcharts. |
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Appendix 2 is a list of frequently
reprocessed devices identified by FDA and categorized by risk. The list includes:
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1. | Is the SUD an implant as defined in 21 CFR Part
860.3(d)?
If the answer to question #1 above is Yes, STOP. SUD is categorized as High Risk. |
2. |
What is the risk of infection according to Flowchart 1?
If the answer to question #2 is High Risk, STOP. SUD is categorized as High Risk. |
3. |
What is the risk of inadequate performance according to Flowchart 2?
If the answer to question #3 is High Risk, STOP. SUD is categorized as High Risk. |
4. |
Did the SUD result in a Moderate Risk on Flowchart 1 or 2? If so, the SUD is categorized as Moderate Risk. |
5. |
Did the SUD result in a Low Risk on Flowcharts 1 AND 2? If so, the SUD is low risk.
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List of Frequently Reprocessed SUDs
Medical |
Device |
Regulation # |
Exempt |
Type of |
Class |
Procode | Risk |
Cardio- vascular |
Angiography catheter | 870.1200 |
N |
510(k) |
II |
DQO |
high |
blood pressure cuff |
870.1120 |
N |
510(k) |
II |
DXQ |
low |
|
cardiac ablation catheter | unclassified |
N |
PMA |
III |
LPB |
high |
|
cardiac guidewire | 870.1330 |
N |
510(k) |
II |
DQX |
high |
|
compressible limb sleeve | 870.5800 |
N |
510(k) |
II |
JOW |
low |
|
Electrophysiology recording catheter | 870.1120 |
N |
510(k) |
II |
DRF |
high |
|
intra aortic balloon catheter |
870.3535 |
N |
510(k) |
III |
DSP |
high |
|
needle | 870.1390 |
N |
510(k) |
II |
DRC |
high |
|
percutaneous transluminal coronary angioplasty (PTCA) catheter | unclassified |
N |
PMA |
III |
LOX |
high |
|
percutaneous transluminal angioplasty (PTA) catheter | unclassified |
N |
510(k) |
II |
LIT |
high |
|
syringes | 870.1670, |
N |
510(k) |
II |
DXT |
high |
|
trocar | 870.1390 |
N |
510(k) |
II |
DRC |
moderate |
|
Respiratory | breathing mouthpiece | 868.5620 |
Y |
N/A |
I |
BYP |
low |
endotracheal tubes |
unclassified |
N |
PMA |
III |
LZN |
high |
|
masks | 868.5550 |
Y |
N/A |
I |
BSJ |
low |
|
oral and nasal catheters | 868.5350 |
Y |
N/A |
I |
BZB |
low |
|
respiratory therapy and anesthesia breathing circuits | 868.5240 |
Y |
N/A |
I |
CAI |
moderate |
|
tracheobronchial suction catheter | 868.6810 |
N |
510(k) |
I |
BSY |
high |
|
Gastro- enterology/ Urology |
biliary sphincterotomes | 876.4300 |
N |
510(k) |
II |
KNS |
high |
biopsy needles | 876.1075 |
N |
510(k) |
II |
FCG |
high |
|
endoscopic guidewires | 876.1500 |
N |
510(k) |
II |
KOG |
low |
|
endoscopic staplers |
876.4400 |
N |
510(k) |
II |
FHN |
low |
|
extraction balloons/baskets | 876.1500 |
N |
510(k) |
II |
KOG |
high |
|
non-electric biopsy forceps |
876.1075 |
N |
510(k) |
II |
FCL |
high |
|
trocar | 876.5090 |
N |
510(k) |
II |
FBQ |
low |
|
urethral catheters |
876.5130 |
N |
510(k) |
II |
KOD |
moderate |
|
Nephrology | hemodialysis blood tubing |
876.5820 |
N |
510(k) |
II |
KOC |
moderate |
OB-GYN | laparoscopic dissectors | 884.1720 |
Y |
N/A |
I |
HET |
low |
laparoscopic graspers | 884.1720 |
Y |
N/A |
I |
HET |
high |
|
laparoscopic scissors | 8884.1720 |
Y |
N/A |
I |
HET |
high |
|
trocar | 884.1720 |
N |
510(k) |
II |
HET |
low |
|
Orthopedics | arthroscopy instruments | 888.1100 |
N |
510(k) |
II |
HRX |
low |
carpal tunnel blade |
888.4540 |
Y |
N/A |
I |
LXH |
moderate |
|
drill bits | 878.4540 |
Y |
N/A |
I |
HTW |
low |
|
external fixation device | 878.3900, |
Y |
N/A |
I |
FZF, |
low |
|
flexible reamers/drills | 886.4070 |
Y |
N/A |
I |
GEY, |
low |
|
saw blades | 878.4820 |
Y |
N/A |
I |
GFA, |
low |
|
surgical drills | 878.4820 |
Y |
N/A |
I |
GEY, |
low |
|
Surgery | biopsy forceps | 876.1075 |
N |
510(k) |
II |
FCL |
high |
biopsy needles | 878.4800 |
Y |
N/A |
I |
DWE |
high |
|
burr | 878.4820 |
Y |
N/A |
I |
GFF, |
low |
|
electrosurgical electrodes/ handles/ pencils |
876.4300 |
N |
510(k) |
II |
HAM, GEI, FAS, FEH, KNS |
moderate |
|
endoscopes | 876.1500 |
N |
510(k) |
II |
many |
high |
|
endoscopic blades |
876.1500 |
N |
510(k) |
II |
GCP, |
moderate |
|
endoscopic guidewires | 876.1500 |
N |
510(k) |
II |
GCP, |
low |
|
enodoscopic staplers | 888.4540 |
Y |
N/A |
I |
HXJ |
moderate |
|
fascia holders | 878.4800 |
Y |
N/A |
I |
moderate |
||
laproscope | 884.1720 |
N |
510(k) |
II |
HET, |
low |
|
laser fiber delivery systems |
878.4810 |
N |
510(k) |
II |
GEX, |
low |
|
scissor tips, removable inserts |
878.4800 |
Y |
N/A |
I |
LRW, HHR, HDK, HDJ, JZB, KBD |
moderate |
|
surgical cutting accessories | 878.4800 |
Y |
N/A |
I |
GDZ, GDX, GES, KBQ, KAS |
moderate |
|
trocar | 874.4420 |
Y |
N/A |
I |
KAB |
moderate |
|
trocar | 874.4420 |
N |
510(k) |
II |
FBQ, FBM, GCJ, DRC |
moderate |
|
Plastic Surgery | stapler | 878.4800 |
Y |
N/A |
I |
GAG, GEF, FHM, HBT, HBS |
moderate |
Laboratory | glucometer lancets | 878.4800 |
Y |
N/A |
I |
FMK |
low |
Ophthalmic | keratome blade | 886.4370 |
N |
510(k) |
I |
HMY, |
high |
OR drapes | 878.4370 |
N |
510(k) |
II |
KKX |
moderate |
|
phacoemulsification needle | 886.4670 |
N |
510(k) |
II |
MUS |
high |
|
Infection Control | OR gowns | 878.4040 |
N |
510(k) |
II |
FYA |
low |
sharps containers | 880.5570 |
N |
510(k) |
II |
MTV, FMI |
low |
|
syringes, piston | 880.5860 |
N |
510(k) |
II |
FMF |
high |
|
General Hospital | infusion pump, implanted | unclassified |
N |
PMA |
III |
MDY, LKK |
high |
syringe, irrigating | 880.6960 |
Y |
N/A |
I |
KYZ, KYY |
low |
|
Dental | braces, plastic | 872.5470 |
N |
510(k) |
II |
DYW |
high |
braces, metal | 872.5410 |
Y |
N/A |
I |
EJF |
high |
|
burr | 872.3240 |
Y |
N/A |
I |
EJL |
moderate |
Updated February 16, 2000
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